A Randomized Phase II Clinical Trial to Evaluate the Efficacy Alternating mFOLFOX/mFOLFIRI Chemotherapy Regimen as a Second-line Treatment for Advanced Biliary Tract Cancer

In second line with advanced or recurrent biliary tract cancer refractory to first line gemcitabine plus cisplatin,efficacy of mFOLFOX/FOLFIRI vs mFOLFOX will be evaluated at randomized phase 2 trial.

Start Date01 Aug 2025

Sponsor / Collaborator

Seoul National University Bundang Hospital

NCT06941857

/ Not yet recruitingPhase 2IIT

A Phase 2 Study of NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Treatment-naïve, Metastatic Pancreatic Cancer

The purpose of this study is to evaluate safety of the treatment regimen and identify any novel toxicities.

Start Date01 Jul 2025

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+2]

NCT07012798

/ Not yet recruitingPhase 2IIT

A Prospective, Single-arm, Single-center Phase II Clinical Study of Hepatic Artery Infusion Chemotherapy (FOLFOX) Combined With Durvalumab (MEDI4736), Bevacizumab, and Stereotactic Body Radiotherapy in Sequential Treatment of Potentially Resectable Locally Advanced Hepatocellular Carcinoma

Study Design:
This is a pilot study with a single arm in a single centre assessing safety and efficacy of durvalumab in combination with bevacizumab and HAIC followed by SBRT. This study will be conducted in selected patients with intermediate or advanced stage HCC not amenable to curative therapy. Approximately 30 patients will be enrolled and receive treatments.
Primary Objectives:
To evaluate the possibility of HAIC plus durvalumab and bevacizumab followed by SBRT as conversion therapy for HCC.
Secondary Objective(s):
To evaluate the efficacy of HAIC plus durvalumab and bevacizumab followed by SBRT for HCC.
To evaluate the safety of HAIC plus durvalumab and bevacizumab followed by SBRT for HCC.
Exploratory Objective(s):
Evaluate the consistency of imaging CR and pathological CR in resected patients, and explore biomarkers associated with prognosis .

Start Date30 Jun 2025

Sponsor / Collaborator

Tianjin Medical University Cancer Institute and Hospital

100 Clinical Results associated with Folinic Acid

100 Translational Medicine associated with Folinic Acid

100 Patents (Medical) associated with Folinic Acid

9,726

Literatures (Medical) associated with Folinic Acid

01 Dec 2025·Journal of Gastrointestinal Cancer

Final Results of ERBIMOX: A Randomized Phase II Study of Modified FOLFOX7 With or Without Cetuximab as First-Line Treatment for KRAS Wild-type Metastatic Colorectal Cancer

Article

Author: Zirrgiebel, Ute ; Depenbusch, Reinhard ; Müller, Lothar ; Lerchenmüller, Christian ; Boller, Emil ; Niemeier, Beate ; Marschner, Norbert ; Sahm, Stephan ; Tesch, Hans ; Potthoff, Karin

BACKGROUND:

The combination of FOLFOX/FOLFIRI with an EGFR-antibody (cetuximab/panitumumab) is a first-line standard for RAS wild-type metastatic colorectal cancer (mCRC). The OPTIMOX stop-and-go regimen, which reduces oxaliplatin-induced neuropathy, and fluorouracil/folinic acid (FU/FA) were standard maintenance-therapies in the pre-antibody era. Whether an EGFR-antibody adds value to the OPTIMOX strategy in the RAS wild-type setting remains unknown.

METHODS:

In the open-label, randomized, multicenter phase II ERBIMOX trial, patients with KRAS wild-type mCRC received either first-line induction-therapy with 8 cycles of mFOLFOX7 followed by maintenance-therapy with FU/FA (OPTIMOX arm) or mFOLFOX7 + cetuximab followed by FU/FA + cetuximab (ERBIMOX arm). Primary objective was to demonstrate superiority of additional cetuximab to mFOLFOX7 during induction/maintenance-therapy. Primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS) and safety. The trial is registered at EudraCT (No.2006-002744-28).

RESULTS:

From 2006-2011, 138 patients with KRAS wild-type mCRC from 23 German sites were randomly assigned to either OPTIMOX (N = 63) or ERBIMOX (N = 75). ORR numerically favored the ERBIMOX arm (64.0% vs. 54.0%, P = 0.3071). Median PFS (ERBIMOX vs. OPTIMOX) was 9.6 vs. 8.8 months (P = 0.7612), median OS 25.6 vs. 30.9 months (P = 0.5821). Most common grade 3/4 adverse events (AEs) were skin reactions (21.9% vs. 2.1%) and gastrointestinal disorders (13.5% vs. 9.5%). No cetuximab-related deaths occurred.

CONCLUSION:

In treatment-naïve KRAS wild-type mCRC, adding cetuximab to mFOLFOX7 resulted in numerically higher ORR than mFOLFOX alone, but no statistically significant differences in ORR, PFS or OS; probably because of the premature stop due to poor recruitment. The safety profile was as expected, with few discontinuations.

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

New recommendations for reversal of high-dose methotrexate cytotoxicity with folinic acid

Review

Author: Heldrup, Jesper ; Guscott, Martin ; Chatelut, Etienne ; Bleyer, Archie ; Ten, Carolina ; Schwartz, Stefan ; Howard, Scott ; Ramsey, Laura ; Hwang, Miriam ; Schaff, Lauren ; Bernhardt, Brooke

PURPOSE:

Folinic acid (FA) rescue protocols to counter the adverse effects of high-dose methotrexate (HDMTX) vary widely, and the risk of over-rescue and potential adverse effects of excessive FA (e.g., hypercalcemia) are under-recognized issues when providing augmented rescue in cases of delayed methotrexate elimination (DME). This opinion summary defines over-rescue, describes its potential adverse impacts, highlights the risk of hypercalcemia associated with excessive FA dosing in patients with acute kidney injury (AKI) from HDMTX, and provides recommendations to improve safety and efficacy of FA rescue in patients receiving HDMTX.

METHODS:

A multidisciplinary panel of experts with clinical experience in HDMTX treatment convened in three roundtable meetings to coalesce expert opinion and best published evidence on the pharmacology and clinical effects and interactions of FA and HDMTX.

RESULTS:

The type of FA (calcium folinate, calcium levofolinate, sodium levofolinate), dose, and frequency of FA administration may be factors for over-rescue and the development of hypercalcemia due to their respective pharmacokinetic characteristics, especially in cases of DME requiring augmented FA rescue.

CONCLUSION:

Clinicians are reminded of the possibility of over-rescue with FA and its impact on subsequent HDMTX courses, types of FA available and their durations of action, and avoid providing too frequent doses. In the setting of AKI and DME requiring high doses of FA, use of sodium levofolinate or calcium levofolinate may be considered to reduce the risk of hypercalcemia associated with calcium folinate.

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Dose adjustment strategy for high-dose methotrexate-induced toxicities in pediatric acute lymphoblastic leukemia: based on population PK analysis and exposure-toxicity relationship

Article

Author: Zuo, Zhong ; Xuan, Qiaolan ; Zhang, Yating ; Liu, Shu ; Fang, Jianpei ; Cao, Ailing ; Xu, Lvhong ; Li, Xinyu ; Wang, Jian ; Qiu, Kunyin ; Wang, Xueding ; Guan, Yanping ; Zhou, Dunhua ; Huang, Min

PURPOSE:

High-dose methotrexate (HD-MTX) is the cornerstone of the therapy for acute lymphoblastic leukemia (ALL). However, severe adverse events are frequently reported despite standard supportive cares. Therefore, we aim to develop a new strategy to individualize HD-MTX and improve patient safety.

METHODS:

A retrospective study was conducted in which toxicity were evaluated in 134 patients with 461 HD-MTX treatment courses. All of the patients experienced standard supportive cares. Exposure-toxicity analysis was conducted to obtain the target concentration and area under the curve (AUC) of MTX. Population PK model was established for dose simulations.

RESULTS:

A high rate of severe toxicities (78.1%) was observed. Patients with C_24h above 75 µmol/L were at high risk for developing serious myelosuppression (P < 0.001) or hepatic injury (P = 0.005) within each cycle. Moreover, although no effect of AUC_0-24 h was found on toxicities within the relative cycle, a prolonged effect of MTX overexposure was observed on the toxicities in the next cycle. When the AUC_0-24 h levels were above 1447 µmol/L·h, patients were more likely to develop serious myelosuppression (P = 0.004) in the subsequent cycle. Based on the C_24h and AUC_0-24 h levels and the known required effective doses, reducing the dose from 5 g/m² to 2-3 g/m² according to the risk stratification is recommended to prevent related toxicities.

CONCLUSION:

MTX C_24h and AUC_0-24 h levels are the predictors of HD-MTX-related toxicity. For patients with overdose of HD-MTX, a new dose adjustment strategy is established to improve patient safety and optimize clinical benefit.

News (Medical) associated with Folinic Acid

27 May 2025

·www.prnewswire.com

AbbVie Features New Data Across Difficult-to-Treat Solid Tumors and Blood Cancers at ASCO 2025, Highlighting Breadth and Depth of its Oncology Portfolio

- Key oral presentations highlight new data from AbbVie's novel investigational antibody-drug conjugates (ADCs) including telisotuzumab adizutecan (ABBV-400, Temab-A) in advanced non-small cell lung cancer (NSCLC), ABBV-706 in high-grade neuroendocrine neoplasms (NENs) and pivekimab sunirine (PVEK) in blastic plasmacytoid dendritic cell neoplasm (BPDCN). NORTH CHICAGO, Ill., May 27, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that key data from its broad oncology portfolio will be showcased across multiple oral presentations and posters at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 - June 3, 2025). These new data highlight significant progress in AbbVie's robust oncology pipeline, across a range of difficult-to-treat solid tumors and blood cancers. "The data we're presenting at this year's ASCO reflect the breadth and depth of our oncology pipeline and our unwavering commitment to research that could transform outcomes for patients facing cancer," said Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "These presentations underscore our leadership in driving scientific innovation to address some of the most pressing unmet needs in oncology today by leveraging our innovative platforms such as ADCs." An oral presentation on investigational telisotuzumab adizutecan (ABBV-400, Temab-A), a next-generation, c-Met directed antibody-drug conjugate (ADC) with a novel topoisomerase 1 inhibitor (Top1i) payload, will showcase: Preliminary safety and efficacy results in 41 patients with pre-treated, advanced epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) from the dose expansion part of a Phase 1 study (NCT05029882).1 Patients received a median of 3 prior lines of therapies and 93% of patients had prior anti-EGFR treatment. The objective response rate (ORR) was 63%.1 High ORR was observed regardless of c-Met protein expression levels.1 At the time of data cut-off, 54% of responders experienced a ≥6 months duration of response (DoR).1 The most common any-grade TEAEs in ≥30% of patients were anemia (63%), nausea (61%), vomiting (37%), decreased appetite (34%), and neutropenia (34%).1 Additional data with 4 months follow-up will be presented at ASCO. Temab-A is also being evaluated in multiple ongoing clinical trials including a Phase 1/2 Study (NCT06772623) in first-line NSCLC without actionable genomic alterations in combination with budigalimab (AbbVie's investigational programmed cell death 1 inhibitor), a Phase 2 study (NCT06107413) in second-line metastatic colorectal cancer (CRC) in combination with fluorouracil, folinic acid and bevacizumab, and a Phase 3 study (NCT06614192) as monotherapy in patients with c-Met overexpressing refractory metastatic CRC. "The anti-tumor activity of Temab-A in patients with pre-treated, advanced EGFR-mutated non-squamous NSCLC is encouraging and supports further exploration of this novel ADC in this setting," said Ross Camidge, M.D., Ph.D, University of Colorado Cancer Center, United States and principal investigator of the trial. "Temab-A appears to have a manageable safety profile and continues to show promising clinical activity in advanced NSCLC, which is associated with poor prognosis." Additional oral presentations will highlight new safety and efficacy data for ABBV-706, a SEZ6-directed ADC with a Top1i payload, and pivekimab sunirine (PVEK), a novel ADC designed to target CD123: In a Phase 1 open-label study of ABBV-706 monotherapy, 64 patients with high-grade neuroendocrine neoplasms (NENs), a diverse group of rare and aggressive solid tumors, received ABBV-706 monotherapy IV at 1.3–3.5 mg/kg once every 3 weeks.2,3 The entire cohort had an ORR of 31.3%, and a median DoR of 5.6 months.2 The most common grade ≥3 TEAEs (cumulative across all dose levels), were anemia (45%), neutropenia (33%), and thrombocytopenia (21%).2 Additional data will be presented at ASCO. This ongoing study (NCT05599984) is evaluating ABBV-706 as monotherapy, or in combination with budigalimab, carboplatin, or cisplatin, in patients with advanced solid tumors expressing SEZ6, including small-cell lung cancer, NENs and high-grade Central Nervous System tumors. Results from the open-label, multicenter Phase 1b/2 CADENZA trial (NCT03386513) of PVEK monotherapy in patients with previously untreated or relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN), a highly aggressive and rare type of blood cancer, demonstrated clinical benefit.4,5 The results show that among 33 untreated patients, the primary endpoint of composite complete response (CCR) rate, defined as CR + clinical CR (CR with minimal skin abnormality), was 70% (95% CI, 51.3-84.4) with a median duration of CCR of 9.8 months. ORR was 85%.4 In the 51 patients with R/R BPDCN, the CCR rate was 14% with a median duration of CCR of 9.2 months. ORR was 35%.4 Among all the 84 patients enrolled, the most common grade ≥3 TEAEs were peripheral edema (12%).4 TEAEs led to discontinuation in 9% and 7% of patients with first-line and R/R BPDCN, respectively. 4 Additional data will be presented at ASCO. PVEK is also being evaluated in a Phase 1/2 study (NCT04086264) in R/R and newly diagnosed acute myeloid leukemia. "Over the past few years, we've significantly expanded our ADC portfolio to investigate a broad range of solid tumors and blood cancers, reflecting our deep commitment to transforming cancer care through targeted therapies and biomarker driven approaches," said Daejin Abidoye, M.D., vice president, therapeutic area head of solid tumors, AbbVie. "These results highlight the potential of our investigational medicines to offer a meaningful clinical benefit in multiple difficult-to-treat cancers, where current treatment options are limited." Further information on AbbVie clinical trials is available at . Additional details on key presentations at ASCO are available below and the full ASCO Annual Meeting 2025 abstracts are available here. Telisotuzumab adizutecan, ABBV-706, pivekimab sunirine, etentamig, livmoniplimab, budigalimab, ABBV-291 and ABBV-969 are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies. Venetoclax, ibrutinib, epcoritamab, telisotuzumab vedotin are approved medicines being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses. EPKINLY ®/TEPKINLY ® (epcoritamab) is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. VENCLEXTA®/VENCLYXTO® (venetoclax) is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. IMBRUVICA® (ibrutinib) is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc. U.S. Prescribing Information for AbbVie Medicines Please see full Prescribing Information for EMRELIS™ (telisotuzumab vedotin-tllv) Please see full Prescribing Information for EPKINLY® (epcoritamab-bysp) Please see full Prescribing Information for IMBRUVICA® (ibrutinib) Please see full Prescribing Information for VENCLEXTA® (venetoclax tablets) About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube. About AbbVie in Oncology AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit . Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References: Camidge R, Raimbourg J, Lee Y-G, et al. Telisotuzumab Adizutecan (ABBV-400; Temab-A), a c-Met Protein-Targeting Antibody-Drug Conjugate, in Patients With Advanced EGFR Mutated Non-Squamous NSCLC: Results From a Phase 1 Study. Abstract 8512 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Cooper A, Chandana S, Furqan M, et al. Safety and efficacy of ABBV-706, a seizure-related homolog protein (SEZ6)- targeting antibody-drug conjugate, in high-grade neuroendocrine neoplasms. Abstract 105 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Sultana Q, Kar J, Verma A, et al. A Comprehensive Review on Neuroendocrine Neoplasms: Presentation, Pathophysiology and Management. J Clin Med. 2023 Aug 5;12(15):5138. doi: 10.3390/jcm12155138. Pemmaraju N, Marconi G, Montesinos P, et al. Efficacy and safety of pivekimab sunirine (PVEK) in patients (pts) with blastic plasmacytoid dendritic cell neoplasm (BPDCN) in the CADENZA study. Abstract 6502 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Cazzato G, Capuzzolo M, Bellitti E, et al. Blastic Plasmocytoid Dendritic Cell Neoplasm (BPDCN): Clinical Features and Histopathology with a Therapeutic Overview. Hematol Rep 2023;15(4):696-706 doi: 10.3390/hematolrep15040070. Contacts: SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultASCOPhase 1ADCPhase 2

04 Feb 2025

·www.drugs.com

Dual-Targeted Therapies Plus Chemo Improve Objective Response Rate in BRAF V600E Metastatic CRC

TUESDAY, Feb. 4, 2025 -- For patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC), encorafenib + cetuximab (EC) plus standard chemotherapy (modified folinic acid [or levofolinate], fluorouracil , and oxaliplatin regimen [mFOLFOX6]) is associated with an improved objective response rate compared with standard of care (SOC), according to a study published online Jan. 25 in Nature Medicine . The research was published to coincide with the American Society of Clinical Oncology annual Gastrointestinal Cancers Symposium, held from Jan. 23 to 25 in San Francisco. Scott Kopetz, M.D., Ph.D., from the University of Texas MD Anderson Cancer Center in Houston, and colleagues examined EC+mFOLFOX6 versus SOC in patients with previously untreated BRAF V600E mCRC in the phase 3 BREAKWATER study. At data cutoff, data were not mature for the dual primary end point of progression-free survival. However, the researchers found that BREAKWATER met the other dual primary end point of objective response rate, demonstrating a significant and clinically relevant improvement (60.9 versus 40.0 percent for EC+mFOLFOX6 versus SOC; odds ratio, 2.443). The median duration of response was 13.9 and 11.1 months, respectively. The hazard ratio was 0.47 at this first interim analysis of overall survival. The safety profiles were consistent with those known for each agent; serious adverse event rates were 37.7 and 34.6 percent in the EC+mFOLFOX6 and SOC groups, respectively. "These encouraging data support this regimen to potentially become the new SOC in BRAF V600E-mutant mCRC; prespecified analyses of mature progression-free survival and overall survival data are planned," the authors write. Several authors disclosed ties to biopharmaceutical companies, including Pfizer, which sponsored BREAKWATER; support was also received from other pharmaceutical companies. Abstract/Full Text More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

ASCOClinical ResultPhase 3

03 Feb 2025

·www.pharmaceutical-technology.com

Pfizer’s colon cancer combo approval further supported by Phase III win

The top-line data also saw statistically significant and clinically meaningful improvement in overall survival (OS). Credit: Shutterstock / NMK-Studio. Pfizer ’s metastatic colorectal cancer (mCRC) combination therapy has met one of the primary endpoints of improving progression-free survival (PFS) in a Phase III trial, further supporting a full approval. The company’s active-controlled, open-label BREAKWATER trial (NCT05217446) evaluating a combination of Pfizer’s Braftovi (encorafenib), Eli Lilly’s Erbitux (cetuximab) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) met one of its dual primary endpoints, improving PFS. The trial investigated the combination in mCRC patients living with a BRAF V600E mutation who are treatment-naive. The top-line data also saw statistically significant and clinically meaningful improvement in overall survival (OS). Additionally, the company has added that no new safety signals have been observed. In December 2024, the US Food and Drug Administration (FDA) granted accelerated approval to the combination therapy of Braftovi, Erbitux and mFOLFOX6. Although it is waiting on full analysis of the final results, Pfizer intends to present its findings in a meeting with the FDA to support full approval. Speaking ahead of World Cancer Day on 4 February, Pfizer’s chief oncology officer Roger Dansey said: “We are extremely pleased with the clinically meaningful PFS and OS results from the BREAKWATER study, which have the potential to be practice-changing for this patient population that has historically had limited treatment options and poor outcomes. “The Braftovi regimen is emerging as a new standard of care as the first targeted therapy approved for use as early as first-line for patients with mCRC with a BRAF V600E mutation.” The multi-centre BREAKWATER trial is also the first trial to be launched under the regulatory body’s Project FrontRunner, an initiative aimed at encouraging sponsors to seek approval for drugs for patients in an earlier stage of clinical treatment. This is as opposed to seeking approval for treatments designed for patients who have already undergone several therapies or treatment options. In the BREAKWATER trial patients were randomised to receive either 300mg of Braftovi and Erbitux alone or in combination with mFOLFOX6. The active control group received mFOLFOX6, FOLFOXIRI (Folinic acid, fluorouracil, oxaliplatin and irinotecan), or CAPOX (capecitabine and oxaliplatin) with or without bevacizumab. A BRAF mutation is a form of cancer in which the BRAF gene begins to cause certain cells to continue dividing without ever receiving a signal to stop. The V600E variant is one of the more common forms of BRAF mutation with the name defining the location and nature of the condition. While some BRAF mutations are susceptible to different forms of targeted therapy, other BRAF mutations are not. Elsewhere in the treatment of mCRC, Tizona Therapeutics has expanded its ongoing Phase Ib clinical trial of TTX-080, a novel antibody targeting human leukocyte antigen-G (HLA-G), in patients with the condition. Meanwhile, Johnson & Johnson has reported a 49% overall response rate in a colorectal cancer study with RYBREVANT.

Clinical ResultPhase 3Phase 1Accelerated ApprovalDrug Approval

100 Deals associated with Folinic Acid

External Link

KEGG	Wiki	ATC	Drug Bank
D07986	Folinic Acid	L01XX	DB00650

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Colorectal Cancer	-	-	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


JPRN-UMIN000043939 (NAPOLEON-2, ASCO_GI2025)	Not Applicable	Pancreatic Cancer neutropenia	150	Nanoliposomal irinotecan and fluorouracil with folinic acid (NFF)	veakjhnolc(jlneohrqjz) = ejuggleiec fmbhiveczc (ytekwoxfev )	Positive	23 Jan 2025
JPRN-UMIN000043939 (NAPOLEON-2, ASCO_GI2025)	Not Applicable	Pancreatic carcinoma non-resectable	150	Nanoliposomal irinotecan and fluorouracil with folinic acid (NFF)	vmminmcnhw(qdrmclihnp) = vzzwkmnsrr uypumapxen (tcvpkughlv, 6.6 - 9.2) View more	Positive	23 Jan 2025
NCT03259035 (CCTG CO.28 \| NEO \| CO.28, CTgov)	Phase 2	Rectal Cancer \| Rectal Adenocarcinoma	58	folinic acid+oxaliplatin+capecitabine+fluorouracil	tuszqrmghh = aduisfejgr makexfwtab (wbeaaikeqc, iuruwkaxby - cphvumztkc) View more	-	10 Oct 2024
JPRN-UMIN000048143 (JON 2109-P, ESMO2024) Manual	Phase 3	Pancreatic Cancer Second line	446	S-1 monotherapy	gcnpghrqni(ymskbyewss) = oephciaxmc rjulnmlyuq (tgcuhucmfw ) View more	Positive	16 Sep 2024
				Nanoliposomal irinotecan plus 5-fluorouracil/leucovorin regimen	gcnpghrqni(ymskbyewss) = bbdxakgsrr rjulnmlyuq (tgcuhucmfw ) View more
NCT01905150 (CTgov)	Phase 2	Pancreatic Cancer	34	VitaminC+G-FLIP-DM (G-FLIP Alone for 4 Weeks, Then G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+VitaminC)	zuwcvamhqm(gbpzesdbmw) = bjfveamhma cufobveeie (jzkcjeiece, zmxakvywnl - fxbwzwiacr) View more	-	14 Aug 2024
				VitaminC+G-FLIP-DM+G-FLIP (G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+Vitamin C.)	zuwcvamhqm(gbpzesdbmw) = anqjowrtot cufobveeie (jzkcjeiece, gddknyptfq - xudpcgagdw) View more
NCT02842580 (HIGH-LIGHT, CTgov)	Phase 2	Metastatic Colorectal Carcinoma	21	acide folinique+Bevacizumab+irinotecan+Oxaliplatin+capécitabine+5FU (Standard Arm (Escalation Strategy - Arm A))	lcublbtvss(osklnarlaq) = zzqvimxtii rpsumhysve (ratfdhaloz, wkvulwmmht - vtrdulwptn) View more	-	10 Jul 2024
				acide folinique+bevacizumab+irinotecan+Oxaliplatin+capécitabine+5FU (Experimental Arm (De-escalation Strategy -Arm B))	lcublbtvss(osklnarlaq) = etfmpuzols rpsumhysve (ratfdhaloz, hketmmkkmk - wbjbmdpmtj) View more
NCT02352337 (PRODIGE 35-PANOPTIMOX \| PANOPTIMOX, CTgov)	Phase 2	Metastatic Pancreatic Cancer	276	Leucovorin Calcium+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (FOLFIRINOX)	ulymeflvkn = rmaijlbqvn alngmbaxfp (gfcbybkhqy, vqmhqkzfic - zjrnvimhdh) View more	-	10 Jul 2024
				LV+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (FOLFIRINOX + LV5FU2 in Maintenance)	ulymeflvkn = plqydihsiy alngmbaxfp (gfcbybkhqy, fcgrimqjok - nkbtiglhru) View more
NAPOLEON-2 (ESMO_GI2024) Manual	Not Applicable	Pancreatic Cancer Second line	87	Nano-liposomal irinotecan, fluorouracil, and folinic acid (NFF)	umqorpxnvg(lswrsjcwcw) = thrfohpifk gzdxzpboma (aqqzkubflc, 6.4 - 9.4) View more	Positive	27 Jun 2024
NCT01515787 (PROSPECT, CTgov)	Phase 2/3	Locally Advanced Rectal Carcinoma	1,194	surgery+leucovorin+Oxaliplatin+5-fluorouracil+capecitabine (Group 1)	mlfsartupm = guuzhtuond ahqkswdxzx (fmdbgdcscn, topjpdweph - buiilkgyrx) View more	-	02 Feb 2024
				surgery+leucovorin+Oxaliplatin+5-fluorouracil+capecitabine (Group 2)	mlfsartupm = dbjamezcju ahqkswdxzx (fmdbgdcscn, hguwarxouu - llgwfgitva) View more
ESMO 12023 \| ESMO 22023 Manual	Not Applicable	Metastatic Pancreatic Cancer	129	pegylated liposomal irinotecan + 5-fluorouracil + leucovorin	ygnsfpjtfk(bghaeocgsx) = ndchsprplu yzjisqgwqb (jdkgaiyclh, 47.4 - 68.7) View more	Positive	23 Oct 2023

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis