TRIFLUOX-DP: Safety of Trifluridine/Tipiracil as Replacement of Fluoropyrimidines (5-fluorouracil and Capecitabine) Based Chemotherapy as First Line Metastatic Colorectal or Gastroesophageal Cancer Regimens in Patients With Dihydropyrimidine Dehydrogenase Deficiency: a Phase II Trial

The goal of this clinical trial is to test the safety of the trifluridine/tipiracil as replacement of fluoropyrimidines based chemotherapy as first line metastatic colorectal or gastroesophageal cancer regimens in patients with dihydropyrimidine dehydrogenase (DPD) deficiency.
The main questions it aims to answer are:
Is this alternative chemotherapy option a better option in term of safety for this type of patients?
Does the combination of treatments improves the overall safety?
Does the combination of treatments improves the progression-free survival, overall survival, objective response rate and disease control rate?
Does the combination of treatment have an effect on quality of life?
Participants will:
Receive the trifluridine/tipiracil with oxaliplatin every 14 days, associated with:
Panitumumab or bevacizumab for colorectal adenocarcinomas
Nivolumab or trastuzumab for gastroesophageal adenocarcinomas.
Have a CT-Scan every 2 months until disease progression
Complete Health-related quality of life questionnaire every 2 months for a maximum of 6 months
Participate to the optional translational research: Blood samples fo DPYD genotyping and pharmacokinetic analysis

Start Date20 Jun 2024

Sponsor / Collaborator

UNICANCER

[+1]

NCT06343116 / Not yet recruitingPhase 3

Randomized Double-blind, Placebo-controlled, Multicenter Clinical Study of Nimotuzumab Combined With Trifluridine/Tipiracil in Third-line and Beyond for the Treatment of Metastatic Colorectal Cancer

This is a randomized, double-blind, placebo-controlled, multicenter study. The main purpose of the study is to evaluate the clinical efficacy and safety of nimotuzumab combined with trifluridine/tipiracil in third-line and beyond for the treatment of metastatic colorectal cancer (mCRC). This study planned to be divided into two parts: Part A and Part B. Part A (safety run-in) with a 3 + 3 study design, which primary endpoint is safety; Part B (main study) with a prospective, randomized, double-blind, placebo-controlled design, which primary endpoint is overall survival (OS).

Start Date01 Apr 2024

Sponsor / Collaborator

Biotech Pharmaceutical Co., Ltd.

NCT06379399 / RecruitingPhase 1/2IIT

Trifluridine/Tipiracil Combined With Cetuximab in the Treatment of Third-line and Above RAS/BRAF Wild-type Metastatic Colorectal Cancer: A Single-center, Prospective Phase Ib/II Study

This study is a single-center, prospective, single-arm exploratory study aimed at evaluating the efficacy and safety of trifluridine/tipiracil in combination with cetuximab in the treatment of third-line and above RAS/BRAF wild-type metastatic colorectal cancer.

Start Date01 Apr 2024

Sponsor / Collaborator

Zhejiang Cancer Hospital

100 Clinical Results associated with Tipiracil Hydrochloride/Trifluridine

100 Translational Medicine associated with Tipiracil Hydrochloride/Trifluridine

100 Patents (Medical) associated with Tipiracil Hydrochloride/Trifluridine

289

Literatures (Medical) associated with Tipiracil Hydrochloride/Trifluridine

01 Feb 2024·Journal of pharmaceutical and biomedical analysis

Simultaneous determination of tipiracil, trifluridine and its metabolite 5-trifluoromethyluracil in human plasma using segmented polarity LC-MS/MS: A fully validated assay with clinical application

Article

Author: Ding, Li ; Li, Xianjing ; Zhang, Xinrui ; Zhou, Qiaoyun ; Zhang, Rong ; Shu, Chang

Trifluridine (FTD) and tipiracil (TPI) hydrochloride tablets (TAS-102) were used for the treatment of patients with metastatic rectal cancer that was resistant to conventional chemotherapy drugs. In this study, a rapid and sensitive liquid chromatography-tandem mass spectrometry method was developed and fully validated for the simultaneous determination of TPI, FTD, and the metabolite 5-trifluoromethyluracil (FTY) of FTD in human plasma. The plasma samples were prepared by protein precipitation. The chromatography separation was performed using ACE Excel 3 AQ (100 × 2.1 mm i.d., 1.7 µm, ACE, England) column protected by a security guard cartridge (4.0 × 2.0 mm i.d., 5 µm, Phenomenex, USA) with a gradient elution of 0.05% acetic acid in water and methanol at a flow rate of 0.35 mL/min. The MS/MS analysis was performed by using multiple reaction monitoring with the segmented polarity (positive for TPI: m/z 243.1→183.0, and negative for FTD: m/z 295.1→252.0 and FTY: m/z 178.9→158.9) electrospray ionization mode. The segmented polarity mode was designed to achieve two advantages: better sensitivity and simultaneous determination of the analytes with different ion polarities. The calibration ranges were as follows: 1.00-250 ng/ for TPI, 8.00-8000 ng/mL for FTD and 5.00-1250 ng/mL for FTY. The selectivity, accuracy, precision, matrix effect, recovery, carryover, dilution integrity and stability test results meet ICH acceptance criteria. The method was evaluated using the RGB model and successfully applied to a clinical study in patients with solid tumors. For TPI, FTD and FTY, the maximum plasma concentration was 137-147 ng/mL, 6160-6240 ng/mL and 724-725 ng/mL, respectively; the plasma elimination half-life was 1.69-1.78 h, 1.70 h, and 3.09-3.14 h, respectively, after an oral administration of 60 mg TAS-102.

13 Dec 2023·Cureus

Clinical Phase I Study of TAS102/Irinotecan/Bevacizumab Combination Therapy in Japanese Patients With Unresectable Metastatic Colorectal Cancer (mCRC)

Article

Author: Takakura, Yuji ; Ohdan, Hideki ; Egi, Hiroyuki ; Kochi, Masatoshi ; Mukai, Shoichiro ; Adachi, Tomohiro ; Hinoi, Takao ; Shimizu, Wataru ; Yoshimitsu, Masanori ; Shimomura, Manabu

BACKGROUND:

In this phase I study, we aimed to examine the safety of a triple combination (TAS-102/irinotecan/bevacizumab) therapy in patients with previously treated metastatic colorectal cancer (mCRC).

METHODS:

In the TAS-102 dose-escalation phase, we determined dose-limiting toxicity (DLT), estimated the maximum tolerated dose (MTD), and determined the recommended dose (RD); in the expansion phase, we evaluated safety. The RD was administered in advance for 10 patients. The TAS-102 dose was increased to 25-35 mg/m² and administered orally twice on days 1-5 and 8-12. Irinotecan (100 mg/m²) and bevacizumab (5 mg/m²) were administered on days 1 and 15 of the treatment, respectively.

RESULTS:

Fifteen patients were enrolled in dose-escalation Levels 1-3, and ten in the expansion phase. A 30 mg/m² TAS-102 dose at Level 2 was administered to three patients, with one presenting grade 4 neutropenia. A 35 mg/m² TAS-102 dose at Level 3 was administered to five patients, with three patients presenting grade 4 neutropenia and grade 3 DLTs. We added three patients at Level 2 and set the MTD at 30 mg/m², with no DLTs. The RD was fixed at 25 mg/m², with no DLTs (N = 10) or treatment-related deaths. One patient showed complete response at Level 2, four presented partial response, and eleven individuals maintained stable disease for over four months. The median progression-free survival duration was 7.6 months, while the median overall survival period was 16.9 months.

CONCLUSION:

The TAS-102/irinotecan/bevacizumab combination therapy was safe, effective, and well-tolerated in patients previously treated with mCRC.

01 Dec 2023·Gan to kagaku ryoho. Cancer & chemotherapy

[A Case of MSI-High Sigmoid Colon Cancer in Which Long-Term Survival Was Achieved by Pembrolizumab for Recurrent Lesions Resistant to Conventional Chemotherapy].

Article

Author: Maruyama, Yuuya ; Hayashishita, Souhei ; Matsuishi, Akira ; Mochizuki, Shotaro ; Monma, Tomoyuki ; Suzuki, Hiroya ; Sakamoto, Wataru ; Fujita, Shotaro ; Tsumuraya, Hideaki ; Sakuma, Mei ; Kono, Koji ; Saze, Zenichiro ; Kanouda, Ryo ; Kaneta, Akinao ; Takiguchi, Chiaki

The patient underwent sigmoidectomy with D3 lymph node dissection and partial bladder resection for sigmoid colon cancer(cT4bN1M0, cStage Ⅲa), after preoperative chemotherapy with mFOLFOX plus panitumumab, and FOLFOXIRI plus bevacizumab. Postoperative adjuvant chemotherapy was performed by 8 courses of CAPOX. He relapsed hilar lymph nodes and peritoneal dissemination after 13 months after surgery, he underwent resection of the recurrent lesions. Four months after, he developed recurrence in liver and peritoneum. Although he was treated with FOLFIRI plus ramucirumab or aflibercept, resulted in progression of disease, then he received trifluridine tipiracil hydrochloride plus bevacizumab. At this point, the Japanese health insulance had started to cover pembrolizumab, this therapy was started as the fourth chemotherapy after the diagnosis of high frequency microsatellite instability(MSI), and then tumor markers rapidly declined. He underwent 38 courses of pembrolizumab, the recurrent lesions both liver and peritoneum disappeared. He had stoma closure, peritoneal dissemination disappeared not only intraoperatively but also in histologically from the peritoneal scar. He has received pembrolizumab for 4 years without another recurrence. Here, we report a case of MSI-high sigmoid colon cancer in which long-term survival was achieved by pembrolizumab for recurrent lesions resistant to conventional chemotherapy.

News (Medical) associated with Tipiracil Hydrochloride/Trifluridine

24 Jun 2024

·pmlive.com

Takeda’s Fruzaqla approved by EC to treat metastatic colorectal cancer in adults

Takeda’s Fruzaqla (fruquintinib) has been approved by the European Commission (EC) to treat adults with previously treated metastatic colorectal cancer (CRC). Patients eligible for the VEGF inhibitor will have received available standard therapies, including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, and anti-VEGF and anti-EGFR agents, and will have progressed on or been intolerant to either trifluridine-tipiracil or regorafenib. CRC, which begins in either the colon or rectum, was the second most common cancer in Europe in 2022, with approximately 538,000 new cases of the disease diagnosed that year. Although early-stage CRC can be surgically resected, Takeda outlined that metastatic CRC “remains an area of high unmet need with poor outcomes and limited treatment options”. The EC’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was based on positive results from the late-stage FRESCO-2 trial, which evaluated Fruzaqla plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated metastatic CRC. The study met all its primary and key secondary efficacy endpoints and demonstrated consistent benefit among patients treated with Fruzaqla regardless of prior therapy type, Takeda said, adding that the drug demonstrated a manageable profile. Teresa Bitetti, president of the global oncology business unit at Takeda, said the approvals marked “an important moment for the colorectal cancer community in the EU”. “We look forward to offering patients a novel treatment option that has a manageable safety profile and can be effective regardless of the prior types of therapies they have received,” she said. Fruzaqla received approval from the US Food and Drug Administration (FDA) in November to treat adults with metastatic CRC who have been previously treated with chemotherapy, an anti-VEGF therapy, and in some cases, an anti-EGFR therapy. The latest authorisation for the therapy comes just two months after Takeda’s Entyvio (vedolizumab) was approved by the FDA for subcutaneous administration in adults with moderately to severely active Crohn’s disease. The company also recently received FDA accelerated approval for the use of its kinase inhibitor Iclusig (ponatinib) in adults who are newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukaemia.

Drug ApprovalClinical ResultAccelerated Approval

24 Jun 2024

·www.pharmaceutical-technology.com

EC approves Takeda’s Fruzaqla for metastatic colorectal cancer

Takeda holds the licence for developing, marketing and manufacturing fruquintinib outside of mainland China, Hong Kong and Macau. Credit: Tada Images / Shutterstock. The European Commission (EC) has approved Takeda’s Fruzaqla (fruquintinib) as a monotherapy for adults with metastatic colorectal cancer who have exhausted currently available standard therapies. This approval is for patients who have advanced on or are not tolerant to treatments including trifluridine-tipiracil and regorafenib. In April 2024, the treatment received a positive opinion from the Committee for Medicinal Products for Human Use. The latest development comes after the US Food and Drug Administration (FDA) granted approval for the same indication in November 2023 . The approval is based on data from the Phase III multi-regional FRESCO-2 trial assessing Fruzaqla along with best supportive care (BSC) versus placebo plus BSC. See Also: Johnson & Johnson seeks FDA approval for Tremfya for Crohn’s disease AstraZeneca’s Truqap and Faslodex combo receives approval in EU The trial met all primary and key secondary efficacy endpoints with the treatment demonstrating benefit regardless of patients’ previous therapy types. The oral inhibitor had a manageable safety profile with adverse reactions that led to discontinuation of treatment. Takeda holds the sole global licence for developing, marketing and manufacturing fruquintinib outside mainland China, Hong Kong and Macau. A submission for Fruzaqla was made to the Japan Pharmaceuticals and Medical Devices Agency in September 2023. Fruquintinib is developed and marketed by Hutchmed in China. It was first approved by the China National Medical Products Administration in September 2018 and commercially launched in China in November of the same year under the brand name ELUNATE. Takeda Global oncology business unit president Teresa Bitetti stated: “The approval marks an important moment for the colorectal cancer community in the EU. For the first time in over a decade, patients with previously treated metastatic colorectal cancer have a new targeted treatment option that can be used irrespective of whether their tumours harbour actionable mutations.”

Drug ApprovalPhase 3License out/in

22 Jun 2024

·pipelinereview.com

Bristol Myers Squibb Announces U.S. FDA Accelerated Approval of KRAZATI® (adagrasib) in Combination with Cetuximab for Adult Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or Metastatic Colorectal Cancer (CRC)

Approval based on results from the Phase 1/2 KRYSTAL-1 study where KRAZATI in combination with cetuximab showed an objective response rate of 34% in pretreated patients with locally advanced or metastatic CRC harboring a KRAS G12C mutation 1 Second FDA approval for KRAZATI – reinforcing its potential across tumor types PRINCETON, NJ, USA I June 21, 2024 I Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for KRAZATI ® (adagrasib) in combination with cetuximab as a targeted treatment option for adult patients with KRAS G12C -mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR) results. Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial. “CRC with a KRAS G12C mutation occurs in approximately 3-4% of CRC patients and has historically been challenging to treat,” 2 said Rona Yaeger, MD, Gastrointestinal Oncologist & Early Drug Development Specialist, Memorial Sloan Kettering Cancer Center. “The FDA approval of KRAZATI combined with cetuximab now provides a new treatment option to these patients when their tumors do not respond well to prior therapies.” The approval is based on results from cohorts of the Phase 1/2 KRYSTAL-1 open-label study which evaluated KRAZATI (600 mg tablets administered orally twice daily) in combination with cetuximab in 94 patients with heavily pretreated CRC harboring a KRAS G12C mutation. The study met its primary endpoint, with a confirmed ORR of 34% (n=94, 95% CI: 25-45) for KRAZATI with cetuximab, all of which were partial responses. The median DOR, one of the secondary endpoints, was 5.8 months (95% CI: 4.2-7.6). 1 Current late-line standard of care options result in limited response rates (ORR 1-6%) after progression on chemotherapy ± VEGF/VEGFR inhibitors. 3,4 KRAZATI is associated with the following Warnings & Precautions: Gastrointestinal adverse reactions including diarrhea, nausea, and vomiting, QTc interval prolongation, hepatotoxicity, and interstitial lung disease (ILD)/pneumonitis. 1 Please see Important Safety Information below. “Today’s approval of KRAZATI in CRC is the second in the U.S. for this therapy and the first for BMS’ recently expanded oncology portfolio. This is an important milestone for BMS and the patients we serve as we deliver on our commitment to provide innovative medicines for cancer,” said Wendy Short Bartie, senior vice president, U.S. Oncology and Hematology at Bristol Myers Squibb. “We are proud to make KRAZATI – the first KRAS G12C inhibitor to be FDA approved beyond non-small cell lung cancer – available to CRC patients, and look forward to further evaluating KRAZATI through our ongoing development program.” In 2022, the FDA granted breakthrough therapy designation for KRAZATI in combination with cetuximab for patients with KRAS G12C -mutated advanced CRC whose cancer has progressed following prior treatment with certain chemotherapy and an anti-VEGF therapy. KRAZATI is an irreversible inhibitor of KRAS G12C with a long half-life (23 hours), dose-dependent pharmacokinetics (PK), and central nervous system (CNS) penetration, which, in combination with cetuximab may enhance inhibition of KRAS-dependent signaling or overcome adaptive feedback. The company partnered with QIAGEN to develop a tissue-based companion diagnostic (CDx) for KRAZATI that is now available. KRAZATI is a registered trademark of Mirati Therapeutics, Inc., a Bristol Myers Squibb company. About KRYSTAL-1 KRYSTAL-1 is an open-label, multicenter, multiple expansion cohort Phase 1/2 trial to determine the safety and efficacy of KRAZATI in patients with advanced colorectal cancer (CRC) that harbor a KRAS G12C mutation. The primary endpoint for the Phase 2 cohort of the KRYSTAL-1 study was objective response rate (ORR). Secondary endpoints included duration of response (DOR). The KRYSTAL-1 study was funded by Mirati Therapeutics, Inc., a Bristol Myers Squibb company. Select Safety Profile from KRYSTAL-1 The safety profile for KRAZATI plus cetuximab was evaluated in patients with KRAS G12C -mutated, locally advanced or metastatic CRC, and is consistent with previous reports and known safety profile of each drug individually. Serious adverse reactions occurred in 30% of 94 patients who received KRAZATI in combination with cetuximab. The most common adverse reactions (≥20%) were rash, nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, headache, dry skin, abdominal pain, decreased appetite, edema, anemia, dizziness, cough, constipation, and peripheral neuropathy. 1 About Colorectal Cancer Colorectal cancer (CRC) is cancer that develops in the colon or the rectum, which are part of the body’s digestive, or gastrointestinal, system. 5 CRC is the third most commonly diagnosed cancer in the world. 6 In 2024, it is estimated that there will be approximately 106,590 new cases of the disease in the U.S.; it is the second leading cause of cancer-related deaths in the U.S. among men and women combined. 7 KRAS is the most frequently mutated oncogene in human cancer and is one that drives oncogenesis in up to 50% of patients with CRC. 2 The KRAS G12C mutation occurs in approximately 3-4% of CRC cases. 2 About KRAZATI ® (adagrasib) KRAZATI (adagrasib) is a highly selective and potent oral small-molecule inhibitor of KRAS G12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRAS G12 C -mutated cancers, as the KRAS G12C protein regenerates every 24-48 hours. 8 KRAS G12C mutations act as oncogenic drivers and occur in approximately 14% of non-small cell lung cancer (NSCLC; adenocarcinoma) and 3% of several other cancers. 9,10 In 2022, KRAZATI was granted accelerated approval for treatment of adult patients with KRAS G12C -mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial. KRAZATI continues to be evaluated as a monotherapy and in combination with other anti-cancer therapies in patients with advanced KRAS G12C -mutated solid tumors, including NSCLC and CRC. Please see U.S. Full Prescribing Information for KRAZATI . INDICATIONS KRAZATI in combination with cetuximab is indicated for the treatment of adult patients with KRAS G12C -mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. KRAZATI , as a single agent, is indicated for the treatment of adult patients with KRAS G12C -mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. These indications are approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for these indications may be contingent upon verification and description of a clinical benefit in confirmatory trials. Please see U.S. Full Prescribing Information for KRAZATI . Bristol Myers Squibb: Creating a Better Future for People with Cancer Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, please visit BMS.com or follow us on LinkedIn , X (formerly Twitter), YouTube , Facebook , and Instagram . 1 KRAZATI. Prescribing Information. Princeton, NJ. Mirati Therapeutics, Inc., a Bristol Myers Squibb company; 2024. 2 Yaeger, R., Weiss, et al. Adagrasib with or without cetuximab in colorectal cancer with mutated KRAS G12C. New England Journal of Medicine . 2023;388(1), 44–54. https://doi.org/10.1056/nejmoa2212419 3 Prager, G., et al. Trifluridine–Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer. New England Journal of Medicine . 2023 May 4;388(18). https://www.nejm.org/doi/full/10.1056/NEJMoa2214963 4 Grothey, A., et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet . https://pubmed.ncbi.nlm.nih.gov/23177514/ 5 What is colorectal cancer? American Cancer Society. (n.d.) https://www.cancer.org/cancer/colon-rectal-cancer/about/what-is-colorectal-cancer.html 6 Globocan 2020, World https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf 7 Colorectal cancer statistics: How common is colorectal cancer? American Cancer Society. (n.d.). https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html 8 Hallin J, Engstrom LD, Hargis L, et al. The KRAS Inhibitor MRTX849 Provides Insight toward Therapeutic Susceptibility of KRAS-Mutant Cancers in Mouse Models and Patients. Cancer Discov . 2020;10(1):54-71 9 Campbell et al, Nature Genetics 2016 “Distinct patterns of somatic genome alterations in lung adenocarcinomas 10 Nassar, A., et al. Distribution of KRASG12C Somatic Mutations across Race, Sex, and Cancer Type. New England Journal of Medicine, 384:185-187. https://doi.org/10.1056/nejmc2030638 SOURCE: Bristol Myers Squibb

Drug ApprovalClinical ResultPhase 3Accelerated ApprovalBreakthrough Therapy

100 Deals associated with Tipiracil Hydrochloride/Trifluridine

External Link

KEGG	Wiki	ATC	Drug Bank
-	Tipiracil Hydrochloride/Trifluridine	L01BC	DB08937

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
HER2-positive gastric cancer	KR	Jeil Pharmaceutical Co., Ltd.	17 Oct 2019
Metastatic Gastric Carcinoma	US	Taiho Oncology, Inc.	22 Feb 2019
Metastatic Gastroesophageal Junction Adenocarcinoma	US	Taiho Oncology, Inc.	22 Feb 2019
Gastroesophageal junction adenocarcinoma	EU	Les Laboratoires Servier SAS	25 Apr 2016
Gastroesophageal junction adenocarcinoma	IS	Les Laboratoires Servier SAS	25 Apr 2016
Gastroesophageal junction adenocarcinoma	LI	Les Laboratoires Servier SAS	25 Apr 2016
Gastroesophageal junction adenocarcinoma	NO	Les Laboratoires Servier SAS	25 Apr 2016
Metastatic Colorectal Carcinoma	US	Taiho Oncology, Inc.	22 Sep 2015
Colorectal Cancer	JP	Taiho Pharmaceutical Co., Ltd.	24 Mar 2014
Stomach Cancer	JP	Taiho Pharmaceutical Co., Ltd.	24 Mar 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 3	FR	Servier Group	30 Jan 2022
Dihydropyrimidine Dehydrogenase Deficiency	Phase 2	-	Les Laboratoires Servier SAS	20 Jun 2024
Adenocarcinoma	Phase 2	CA	AHS Cancer Control Alberta	27 Oct 2021
Advanced gastric carcinoma	Phase 2	CA	AHS Cancer Control Alberta	27 Oct 2021
Advanced Pancreatic Adenocarcinoma	Phase 2	HK	Taiho Pharmaceutical Co., Ltd.	01 Mar 2021
ER-positive/HER2-negative Breast Cancer	Phase 2	NL	Servier Pharmaceuticals LLCStartup	25 Sep 2020
Metastatic Triple-Negative Breast Carcinoma	Phase 2	CA	AHS Cancer Control Alberta	01 Feb 2020
Advanced Colorectal Adenocarcinoma	Phase 2	US	Roswell Park Comprehensive Cancer Center	27 Dec 2019
Colorectal cancer recurrent	Phase 2	US	Roswell Park Comprehensive Cancer Center	27 Dec 2019
Colorectal Cancer, Hereditary Nonpolyposis, Type 1	Phase 2	US	Roswell Park Comprehensive Cancer Center	27 Dec 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04923529 (TAS-102, ESMO_GI2024) Manual	Phase 2	Advanced Pancreatic Adenocarcinoma Third line	28	TAS-102 35mg/m2	ubgntbawrq(hvtfhpnghz) = fmfrdjhowg psorabpydv (hjildkutqt, 37.4 - 69.8) View more	Positive	27 Jun 2024
NCT05481463 (ASCO2024)	Phase 2	Secondary malignant neoplasm of pancreas Third line	11	Surufatinib+TAS-102	dgsdeivate(ddhmwwjosb) = vcnolftgiq ufqnsaxlow (cadlqfrqlb, 1.91 - 3.94) View more	Positive	24 May 2024
				Surufatinib+TAS-102 (without liver metastases)	dgsdeivate(ddhmwwjosb) = isvdwxdiet ufqnsaxlow (cadlqfrqlb, 2.14-NA) View more
ASCO2024	Not Applicable	Metastatic Colorectal Carcinoma	-	trifluridine-tipiracil	whsckycayy(shrtsqtgdu) = ltzdsepifa yinmlauutl (psibtagjkg ) View more	-	24 May 2024
				trifluridine-tipiracil	whsckycayy(shrtsqtgdu) = irdzxdyzow yinmlauutl (psibtagjkg ) View more
NCT04627961 (phase 2 study of trifluridine/tipiracil (FTD/TPI), ASCO2024)	Phase 2	Nasopharyngeal Cancer, Recurrent	33	FTD/TPI	nvnshwatvk(unjsmmsojw) = nfvrvqisvi mcopzbwyui (xjsrbfwcrz ) View more	Positive	24 May 2024
				trifluridine/tipiracil (FTD/TPI)	nvnshwatvk(unjsmmsojw) = uthyirgkoy mcopzbwyui (xjsrbfwcrz )
ASCO2024	Not Applicable	Metastatic Colorectal Carcinoma Second line	68	TAS102/bevacizumab	ahnsoqxnpf(ykbplexmfg) = zvydhlumyr ylkwwkasix (ylyyuckwmu ) View more	Positive	24 May 2024
				TAS102 alone	ahnsoqxnpf(ykbplexmfg) = gifsjsxqzh ylkwwkasix (ylyyuckwmu ) View more
NCT05343013 (MD Anderson INTERCEPT program, ASCO2024)	Phase 2	Adjuvant ctDNA+	15	TAS-102	pzoqxnfzud(efjirtzwok) = oqbkacrczb qggvzyrloy (uezoxtrjla )	Positive	24 May 2024
				TAS-102	pzoqxnfzud(efjirtzwok) = obvmwcnbeh qggvzyrloy (uezoxtrjla )
NCT04564898 (TriComB, ASCO2024)	Phase 1	Metastatic Colorectal Carcinoma	11	Trifluridine/Tipiracil (FTD/TPI) 25mg/sqm BID	pqqyzxxgsu(fycrrxoijb) = Grade 3/4 AEs are listed in the Table gfpjbahwyw (kuvmrnjsyh )	Positive	24 May 2024
				Trifluridine/Tipiracil (FTD/TPI) 30mg/sqm BID
NCT04737187 (SUNLIGHT, ASCO2024)	Phase 3	Colorectal Cancer \| Metastatic Colorectal Carcinoma	492	FTD/TPI + BEV	iahdullcxa(bzhpznnnoc) = snhirseavw xdudzqlaso (rfbcoylwbz ) View more	Positive	24 May 2024
				FTD/TPI alone	iahdullcxa(bzhpznnnoc) = pbgwdrlsod xdudzqlaso (rfbcoylwbz )
ASCO2024	Not Applicable	Metastatic Colorectal Carcinoma Third line RAS wt	866	Trifluridine/tipiracil (T)/Regorafenib (R) sequence	gwwehqpvlt(ttrdqxqzqq) = There were no statistically significant differences in OS between these groups xrlxvdmaci (fauwvrctef ) View more	Negative	24 May 2024
				Regorafenib (R)/Trifluridine/tipiracil (T) sequence
NCT01896856 (Pubmed)	Phase 2	Metastatic Colorectal Carcinoma	104	Guadecitabine and irinotecan	wivkseauqy(cqqjtpdgjt) = 18% in Arm A, 12% in Arm B piloxggppv (lfvuwkohxn ) View more	-	15 May 2024
				Regorafenib or TAS-102

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

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. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis