This research study is studying a combination of drugs as a possible treatment for breast cancer with a BRCA mutation.
The interventions involved in this study are:
Sapacitabine (CYC682)
Olaparib (Lynparza™)

Start Date01 Oct 2018

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+2]

NCT01303796 / CompletedPhase 3

A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.

Start Date01 Oct 2011

Sponsor / Collaborator

Cyclacel Pharmaceuticals, Inc.

NCT01253460 / TerminatedPhase 2IIT

A Phase II Clinical Trial of Sapacitabine, Cyclophosphamide, and Rituximab (SCR) for Relapsed Patients With Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL) and Deletion 11q22-23 by FISH

The goal of this clinical research study is to learn if sapacitabine given in combination with 2 standard drugs (cyclophosphamide and rituximab) can help to control CLL and SLL. The safety of this drug combination will also be studied.

Start Date22 Aug 2011

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+2]

100 Clinical Results associated with Sapacitabine

100 Translational Medicine associated with Sapacitabine

100 Patents (Medical) associated with Sapacitabine

Literatures (Medical) associated with Sapacitabine

01 Jan 2024·Enzyme and microbial technology

Functional characterization of a naphthalene-O-methyltransferase from Nocardia sp. CS682

Article

Author: Dhakal, Dipesh ; Sohng, Jae Kyung ; Poudel, Purna Bahadur ; Lee, Jong Cheol

Methylation plays important roles in biosynthesis, metabolism, signal transduction, detoxification, protein sorting and repair, and nucleic acid processing. Generally the methyltransferases transfer methyl groups in various natural products using S-adenosyl methionine (SAM) as a cofactor. In this study, we examined and functionally characterized ThnM3 (enzyme), by testing various substrates with different chemical structures. Among the tested substrates, 1,8-dihydroxynaphthalene was the best substrate for methylation. Whole-cell biotransformation was performed using the enzyme in engineered Escherichia coli to produce 8-methoxynaphthalene-1-ol, and 1,8-dimethoxynaphthalene derivatives of 1,8-dihydroxynaphthalene. The products were confirmed using high-performance liquid chromatography, mass spectrometry, and nuclear magnetic resonance spectroscopic analyses. Therefore, this study is the first to amplify, express the thnM3 (gene), and functionally characterize theThnM3, which exhibits the regioselective modifications of 1,8-dihydroxynaphthalene.

28 Jul 2023·Journal of microbiology and biotechnology

Identification of 1,3,6,8-Tetrahydroxynaphthalene Synthase (ThnA) from Nocardia sp. CS682.

Article

Author: Magar, Rubin Thapa ; Bridget, Adzemye Fovennso ; Poudel, Purna Bahadur ; Sohng, Jae Kyung

Type III polyketide synthase (PKS) found in bacteria is known as 1,3,6,8-tetrahydroxynaphthalene synthase (THNS). Microbial type III PKSs synthesize various compounds that possess crucial biological functions and significant pharmaceutical activities. Based on our sequence analysis, we have identified a putative type III polyketide synthase from Nocardia sp. CS682 was named as ThnA. The role of ThnA, in Nocardia sp. CS682 during the biosynthesis of 1,3,6,8 tetrahydroxynaphthalene (THN), which is the key intermediate of 1-(α-L-(2-O-methyl)-6-deoxymannopyranosyloxy)-3,6,8-trimethoxynaphthalene (IBR-3) was characterized. ThnA utilized five molecules of malonyl-CoA as a starter substrate to generate the polyketide 1,3,6,8-tetrahydroxynaphthalene, which could spontaneously be oxidized to the red flaviolin compound 2,5,7-trihydroxy-1,4-naphthoquinone. The amino acid sequence alignment of ThnA revealed similarities with a previously identified type III PKS and identified Cys¹³⁸, Phe¹⁸⁸, His²⁷⁰, and Asn³⁰³ as four highly conserved active site amino acid residues, as found in other known polyketide synthases. In this study, we report the heterologous expression of the type III polyketide synthase thnA in S. lividans TK24 and the identification of THN production in a mutant strain. We also compared the transcription level of thnA in S. lividans TK24 and S. lividans pIBR25-thnA and found that thnA was only transcribed in the mutant.

01 Dec 2021·CancerQ1 · MEDICINE

Results of a randomized phase 3 study of oral sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia (SEAMLESS)

Q1 · MEDICINE

Article

Author: Berman, Ellin ; Sekeres, Mikkael A. ; Rizzieri, David A. ; Arellano, Martha L. ; Chiao, Judy H. ; Montesinos, Pau ; Maness, Lori J. ; Buyse, Marc E. ; Gaur, Rakesh ; Altman, Jessica K. ; Solomon, Scott R. ; Luger, Selina M. ; Ravandi, Farhad ; Quick, Donald P. ; Gautier, Marc ; Strickland, Stephen A. ; Schiller, Gary J. ; Claxton, David F. ; Thomas, Xavier G. ; Butrym, Aleksandra ; Seiter, Karen ; Goldberg, Stuart L. ; Venugopal, Parameswaran ; Kadia, Tapan M. ; Begna, Kebede H. ; Baer, Maria R. ; Kantarjian, Hagop M. ; Gaidano, Gianluca

Background:

Acute myeloid leukemia (AML) is fatal in elderly patients who are unfit for standard induction chemotherapy. The objective of this study was to evaluate the survival benefit of administering sapacitabine, an oral nucleoside analogue, in alternating cycles with decitabine, a low‐intensity therapy, to elderly patients with newly diagnosed AML.

Methods:

This randomized, open‐label, phase 3 study (SEAMLESS) was conducted at 87 sites in 11 countries. Patients aged ≥70 years who were not candidates for or chose not to receive standard induction chemotherapy were randomized 1:1 to arm A (decitabine in alternating cycles with sapacitabine) received 1‐hour intravenous infusions of decitabine 20 mg/m2 once daily for 5 consecutive days every 8 weeks (first cycle and subsequent odd cycles) and sapacitabine 300 mg twice daily on 3 consecutive days per week for 2 weeks every 8 weeks (second cycle and subsequent even cycles) or to control arm C who received 1‐hour infusions of decitabine 20 mg/m2 once daily for 5 consecutive days every 4 weeks. Prior hypomethylating agent therapy for preexisting myelodysplastic syndromes or myeloproliferative neoplasms was an exclusion criterion. Randomization was stratified by antecedent myelodysplastic syndromes or myeloproliferative neoplasms, white blood cell count (<10 × 109/L and ≥10 × 109/L), and bone marrow blast percentage (≥50% vs <50%). The primary end point was overall survival (OS). Secondary end points were the rates of complete remission (CR), CR with incomplete platelet count recovery, partial remission, hematologic improvement, and stable disease along with the corresponding durations, transfusion requirements, number of hospitalized days, and 1‐year survival. The trial is registered at ClinicalTrials.gov (NCT01303796).

Results:

Between October 2011 and December 2014, 482 patients were enrolled and randomized to receive decitabine administered in alternating cycles with sapacitabine (study arm, n = 241) or decitabine monotherapy (control arm, n = 241). The median OS was 5.9 months on the study arm versus 5.7 months on the control arm (P = .8902). The CR rate was 16.6% on the study arm and 10.8% on the control arm (P = .1468). In patients with white blood cell counts <10 × 109/L (n = 321), the median OS was higher on the study arm versus the control arm (8.0 vs 5.8 months; P = .145), as was the CR rate (21.5% vs 8.6%; P = .0017).

Conclusions:

The regimen of decitabine administered in alternating cycles with sapacitabine was active but did not significantly improve OS compared with decitabine monotherapy. Subgroup analyses suggest that patients with baseline white blood cell counts <10 × 109/L might benefit from decitabine alternating with sapacitabine, with an improved CR rate and the convenience of an oral drug. These findings should be prospectively confirmed.

News (Medical) associated with Sapacitabine

10 Nov 2022

·www.fiercebiotech.com

After nearly 20 years, Cyclacel kicks phase 3 leukemia drug back to Daiichi

Cyclacel has reversed on its plans for sapacitabine and is now racing forward with CDK2/9 inhibitor fadraciclib. Cyclacel Pharmaceuticals once had high hopes for sapacitabine. But, despite making it all the way to phase 3 in acute myeloid leukemia (AML) as well as midstage studies for other cancers, the biotech has decided to give up and hand the rights back to Daiichi Sankyo. The biotech first licensed the nucleoside analog back in 2003. The original deal tied Cyclacel to securing regulatory approval in a country by 2011, but the company was able to amend this before the deadline. It turned out to be a good call, as over a decade later the biotech still hasn’t been able to get the therapy over the finish line. According to the company’s website, sapacitabine has been evaluated in over 1,000 patients across phase 1, 2 and 3 trials for both hematologic cancers and solid tumors. The therapy also picked up orphan-drug tags for the treatment of both AML and myelodysplastic syndrome from the European Medicines Agency and the FDA. The best hope for the drug was the phase 3 SEAMLESS trial in AML, but the results showed a combination of sapacitabine and Johnson & Johnson’s Dacogen didn’t significantly improve survival rates compared to Dacogen alone. A phase 1 trial in BRCA-mutant metastatic breast cancer also looked promising at one point, but clearly it wasn’t enough for the company to stick with the drug. Sapacitabine is an orally available nucleoside analogue, which acts through a DNA single-strand breaking mechanism that can lead to checkpoint activation. Cyclacel made the announcement to drop the drug in its third-quarter earnings, where the company focused the spotlight on fadraciclib, a CDK2/9 inhibitor undergoing a phase 1/2 study in solid tumors and lymphoma. “We are excited about fadra’s tolerability profile, as well as clear evidence of its anticancer activity as a single agent in late-line patients with lymphoma, gynecological, liver and pancreatic cancers,” CEO Spiro Rombotis said in the release. “We expect to shortly determine the recommended phase 2 dose and advance into phase 2 proof-of-concept stage.” The biotech’s other clinical-stage program is a PLK1 inhibitor called CYC140, which is undergoing a phase 1/2 study in patients with advanced solid tumors and lymphoma.

Phase 3Phase 1Clinical ResultOrphan DrugDrug Approval

10 Nov 2022

·endpts.com

Cyclacel pulls the plug on Daiichi-partnered chemo — 8 years after a failed PhIII in AML

Hovering around penny stock territory, New Jersey-based Cyclacel Pharmaceuticals $CYCC said yesterday it’s finally going to call it quits on a Daiichi Sankyo-partnered cancer drug candidate that saw a Phase III flop in acute myeloid leukemia in late 2014. First licensed from Daiichi back in 2003, Cyclacel says it now wants to terminate the development of sapacitabine, and its license agreement with Daiichi on the drug “for commercial reasons,” with the termination effective by March 23, 2023. Back in late 2014, a data and safety monitoring board called to halt that sapacitabine study in AML due to futility, but the company continued the trial into 2017, ultimately finding that it did not show an overall survival benefit. The median OS was 5.9 months on the study arm versus 5.7 months on the control arm (P = .8902), according to the results published last year. The drug was also tested in mid-stage trials for other cancers like myelodysplastic syndromes and lung cancer. Cyclacel unveils a flop in leukemia 2 years after a call on futility, but still won’t give up Meanwhile, Cyclacel said in its earnings report yesterday that it’s also working on an ongoing Phase I/II study of oral fadraciclib in solid tumors and lymphoma, and its cash runway has been extended through the end of next year.

Phase 3License out/inClinical ResultClinical Trial Termination

09 Nov 2022

·www.biospace.com

Cyclacel Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Business Update

- Oral Fadraciclib Daily Dosing Well Tolerated in 18 Evaluable Patients Treated in Dose-Escalation of Phase 1/2 Trial in Advanced Solid Tumors and Lymphoma - - Two Partial Responses in Lymphoma and 11 Stable Diseases in Advanced Solid Tumors - - Expect to Determine Recommended Phase 2 Dose for Oral Fadraciclib and Start Phase 2 in 1Q 2023 - - Encouraging Activity in First Dose Level of Oral CYC140, PLK1 Inhibitor, with Durable Stable Disease in Two Patients with Ovarian and KRAS G12V mutated Non-Small Cell Lung Cancers - - Cash Runway To End of 2023 - - Conference Call Scheduled for November 9, 2022 at 4:30 pm ET - BERKELEY HEIGHTS, NJ, Nov. 09, 2022 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced third quarter 2022 financial results and provided a business update. “Our recent R&D Day highlighted interim clinical data emerging from our ongoing Phase 1/2 study of oral fadraciclib in solid tumors and lymphoma,” said Spiro Rombotis, President and Chief Executive Officer. “We are excited about fadra’s tolerability profile, as well as clear evidence of its anticancer activity as a single agent in late-line patients with lymphoma, gynecological, liver and pancreatic cancers. Moreover, we are seeing this activity during dose-escalation which is designed to evaluate safety. We expect to shortly determine the recommended Phase 2 dose (RP2D) and advance into Phase 2 proof-of-concept stage. We look forward to reporting updated data from our ongoing Phase 1/2 studies of fadraciclib and CYC140 in 2023.” “We have presented progress with our two clinical-stage programs, oral fadraciclib (CDK2/9 inhibitor) and oral CYC140 (PLK1 inhibitor), at our recent R&D Day and the ENA 2022 meeting,” said Mark Kirschbaum, M.D., Chief Medical Officer. “In the 065-101 study of oral fadra, we have reached the sixth dose level after observing that fadra was well tolerated in the first five dose levels. Two out of three lymphoma patients achieved partial response and 11/15 patients with cervical, endometrial, hepatocellular and ovarian cancers achieved stable disease with target lesion reductions. A pancreatic patient achieved stable disease for 5 cycles of treatment. In addition, we achieved levels of fadraciclib that are adequate to inhibit CDK2 and CDK9 for approximately 5 to 7 hours per dose on continuous dosing. At our R&D Day, we also reported preliminary data from the first two dose levels of our Phase 1/2 study of oral CYC140 in patients with advanced solid tumors and lymphoma. We were surprised to observe stable disease at the first dose level in an ongoing patient with metastatic, KRAS G12V mutated, non-small cell lung cancer for 6 cycles and a patient with metastatic ovarian cancer for 5 cycles. We believe that CYC140 is differentiated from other PLK1 inhibitors by its PLK-centric kinase pro by inhibiting BRD4, a validated, epigenetic target in cancer biology.” Key Corporate Highlights On October 31, 2022 the Company held an R&D Day (Webcast replay) at which updated clinical and preclinical data on fadraciclib and CYC140 were presented: Interim results from oral fadraciclib 065-101 Phase 1/2 study in advanced solid tumors and lymphoma 18 evaluable patients with advanced solid tumors or lymphoma were treated in DL 1-5 (median treatment duration of 2.4 cycles; range 1-5 cycles) Well tolerated at all dose levels thus far 2/3 partial responses (PR) in T-cell lymphoma patients; 4 patients with cervical, endometrial, hepatocellular and ovarian cancer) showed stable disease with target lesion reductions and a pancreatic cancer patient achieved stable disease for 5 cycles Achieved target engagement levels predicted to inhibit CDK2 and CDK9 for approximately 5 to 7 hours per dose on continuous dosing Enrollment continues at DL6 (150mg twice a day, Monday-Friday, weeks 1-4) A principal investigator from Seoul National University Hospital presented preclinical data showing sensitivity to fadra in biliary tract and pancreatic cancer cells obtained from patient specimens Interim findings from oral CYC140 140-101 Phase 1/2 study in advanced solid tumors and lymphoma No dose limiting toxicities observed to date in the first two doses levels (DL1-2) Stable disease at dose level 1 in an ongoing patient with metastatic, KRAS G12V mutated, non-small cell lung cancer for 6 cycles and a patient with metastatic ovarian cancer for 5 cycles Enrollment continues in the 065-102 study of oral fadraciclib in patients with advanced leukemia. The Company will not be pursuing further development of sapacitabine and has advised Daiichi Sankyo Co., Ltd., the licensor, that it wishes to terminate their license agreement for commercial reasons with the termination expected to be effective as of March 23, 2023. Key Near-Term Business Objectives and Expected Timeline 4Q 2022 Determine recommended Phase 2 dose (RP2D) with oral fadraciclib from the Phase 1 stage of 065-101 study with oral fadraciclib in patients with advanced solid tumors and lymphoma 1H 2023 First patient dosed with oral fadraciclib in Phase 2 proof-of-concept stage of 065-101 study in patients with advanced solid tumors and lymphoma Report final data from dose escalation stage of 065-101 study with oral fadraciclib in patients with advanced solid tumors and lymphoma Report interim data from 140-101 study with oral CYC140 in patients with advanced solid tumors and lymphoma 2H 2023 Report interim data from initial cohorts in Phase 2 proof-of-concept stage of 065-101 study with oral fadraciclib in patients with advanced solid tumors and lymphoma Report interim data from dose escalation stage of 065-102 study with oral fadraciclib in patients with advanced leukemia Report final data from dose escalation stage of 140-101 study with oral CYC140 in advanced solid tumors and lymphoma Financial Highlights As of September 30, 2022, cash and cash equivalents totaled $23.7 million, compared to $36.6 million as of December 31, 2021. Net cash used in operating activities was $15.7 million for the nine months ended September 30, 2022 compared to $14.0 million for the same period of 2021. The Company estimates that its available cash will fund currently planned programs to the end of 2023.  Research and development (R&D) expenses were $4.4 million for the three months ended September 30, 2022, as compared to $4.2 million for the same period in 2021. R&D expenses relating to fadraciclib were $2.5 million for the three months ended September 30, 2022, as compared to $3.3 million for the same period in 2021 due to decrease in clinical trial costs of $0.3 million associated with ongoing clinical trials evaluating fadraciclib in Phase 1/2 studies and a reduction of $0.5 million in non-clinical expenditures. R&D expenses related to CYC140 were $1.7 million for the three months ended September 30, 2022, as compared to $0.7 million for the same period in 2021 due to clinical trial costs associated with the CYC140 Phase 1/2 study. General and administrative expenses for the three months ended September 30, 2022, were $2.1 million, compared to $1.8 million for the same period of the previous year due to an increase in professional and legal costs Total other income, net, for the three months ended September 30, 2022, was $0.4 million, compared to $13,000 for the same period of the previous year. The increase of $0.3 million for the three months ended September 30, 2022, is primarily related to foreign exchange gains. United Kingdom research & development tax credits were $1.0 million for each of the three months ended September 30, 2022 and September 30, 2021 and are directly correlated to qualifying research and development expenditure. Net loss for the three months ended September 30, 2022, was $5.1 million, compared to $5.0 million for the same period in 2021.  Conference call information: US/Canada call: (800) 579-2543 / international call: (785) 424-1789 US/Canada archive: (888) 276-5315 / international archive: (402) 220-2332 Code for live and archived conference call is CYCCQ322. Webcast Link For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at . The webcast will be archived for 90 days and the audio replay for 7 days. About Cyclacel Pharmaceuticals, Inc. Cyclacel is a clinical-stage, biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and mitosis biology. The transcriptional regulation program is evaluating fadraciclib, a CDK2/9 inhibitor, and the anti-mitotic program CYC140, a PLK1 inhibitor, in patients with both solid tumors and hematological malignancies. Cyclacel's strategy is to build a diversified biopharmaceutical business based on a pipeline of novel drug candidates addressing oncology and hematology indications. For additional information, please visit . Forward-looking Statements This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and intended utilization of Cyclacel’s product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, trials may have difficulty enrolling, Cyclacel may not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, the potential effects of the COVID-19 pandemic, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings we the Securities and Exchange Commission and are available at . Such forward-looking statements are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts Company: Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com Investor Relations: Irina Koffler, LifeSci Advisors, LLC, (646) 970-4681, ikoffler@lifesciadvisors.com © Copyright 2022 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc. SOURCE: Cyclacel Pharmaceuticals, Inc. CYCLACEL PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (LOSS) (In $000s, except share and per share amounts) Three Months Ended September 30, 2022 2021 Revenues: Total revenues - - Operating expenses: Research and development 4,413 4,217 General and administrative 2,054 1,781 Total operating expenses 6,467 5,998 Operating loss (6,467 ) (5,998 ) Other income (expense): Foreign exchange gains (losses) 276 9 Interest income 67 4 Other income, net 14 - Total other income (expense), net 357 13 Loss before taxes (6,110 ) (5,985 ) Income tax benefit 1,014 998 Net loss (5,096 ) (4,987 ) Dividend on convertible exchangeable preferred shares (50 ) (50 ) Net loss applicable to common shareholders $ (5,146 ) $ (5,037 ) Basic and diluted earnings per common share: Net loss per share – basic and diluted $ (0.42 ) $ (0.54 ) Weighted average common shares outstanding 12,314,679 9,368,056 CYCLACEL PHARMACEUTICALS, INC.  CONSOLIDATED BALANCE SHEET (In $000s, except share, per share, and liquidation preference amounts) September 30, December 31, 2022 2021 ASSETS Current assets: Cash and cash equivalents $ 23,706 $ 36,559 Prepaid expenses and other current assets 4,209 4,383 Total current assets 27,915 40,942 Property and equipment, net 37 64 Right-of-use lease asset 153 30 Non-current deposits 2,916 1,551 Total assets $ 31,021 $ 42,587 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 983 $ 2,117 Accrued and other current liabilities 3,370 3,177 Total current liabilities 4,353 5,294 Lease liability 107 30 Total liabilities 4,460 5,324 Redeemable common stock 4,494 - Stockholders’ equity 22,067 37,263 Total liabilities and stockholders’ equity $ 31,021 $ 42,587

Financial Statement

100 Deals associated with Sapacitabine

External Link

KEGG	Wiki	ATC	Drug Bank
D09722	Sapacitabine	-	DB06365

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia	Phase 3	DK	Bloodwise	26 Mar 2011
Myelodysplastic Syndromes	Phase 3	DK	Bloodwise	17 Mar 2011
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma	Phase 3	DK	Bloodwise	10 Mar 2011
Breast Cancer	Phase 2	US	Cyclacel Pharmaceuticals, Inc.	04 Sep 2018
Recurrent Chronic Lymphoid Leukemia	Phase 2	US	Cyclacel Pharmaceuticals, Inc.	22 Aug 2011
Small Lymphocytic Lymphoma	Phase 2	US	Cyclacel Pharmaceuticals, Inc.	22 Aug 2011
Chronic Lymphocytic Leukemia	Phase 2	US	Anderson University	29 Jun 2011
Non-Small Cell Lung Cancer	Phase 2	US	Cyclacel Pharmaceuticals, Inc.	01 Dec 2008
Cutaneous T-Cell Lymphoma	Phase 2	US	Cyclacel Pharmaceuticals, Inc.	01 Apr 2007
BRCA mutation positive Breast Cancer	Phase 1	US	Cyclacel Pharmaceuticals, Inc.	01 Oct 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AACR2023 Manual	Phase 1	Breast Cancer BRCA1 Mutation \| BRCA2 Mutation	10	sapacitabine+olaparib	ifeywiliro(gnqbpsvbrj) = not determined vvfulrnmjs (jxjgedaave ) View more	Negative	14 Apr 2023
NCT01303796 (SEAMLESS, CTgov)	Phase 3	Acute Myeloid Leukemia	482	Decitabine+Sapacitabine (Sapacitabine-decitabine Alternating)	hzvgxxqxkh(uwqhktaerv) = anpygutjco whcwijkioi (nwkqiyetjc, agqmrkfmfz - tjcemwxeym) View more	-	22 Jun 2022
				Decitabine (Decitabine)	hzvgxxqxkh(uwqhktaerv) = ngqfxmuaad whcwijkioi (nwkqiyetjc, dtsjadjget - ihkyjmqgsb) View more
NCT01303796 (Pubmed \| Cancer) Manual	Phase 3	Acute Myeloid Leukemia	482	decitabine+sapacitabine	lqhsbxghaa(hbqozymnzf) = lpplvdocjg llwyaaldpp (ygcfqmfvzt ) View more	Positive	01 Dec 2021
				decitabine	lqhsbxghaa(hbqozymnzf) = eanuukqdjv llwyaaldpp (ygcfqmfvzt ) View more
NCT01253460 (CTgov)	Phase 2	Chronic Lymphocytic Leukemia \| Recurrent Chronic Lymphoid Leukemia \| Small Lymphocytic Lymphoma	18	cyclophosphamide+Sapacitabine+Rituximab	luqwgqdggq(orufiotnyb) = rfjtxbnoqp qvxrcgtpzn (hgpvhohhbq, ewfgrnosih - hmlkvqhttu) View more	-	06 Sep 2019
NCT00999401 (ASCO2016)	Phase 1	HR-positive/HER2-low Solid Tumors	67	Sapacitabine 50 mg b.i.d./Seliciclib 1200 mg b.i.d.	twvkxncobg(uyrrsvhrex) = 7% eiflkdomfv (gymueqqowx ) View more	Positive	20 May 2016
				Sapacitabine 250 mg q.d./Seliciclib 200 mg q.d.
AACR2013	Phase 1	Solid tumor	38	Sapacitabine	ybfhydazbs(pbblboppqd) = qhjzqztvvj fqbhzmbocu (jpiiyrkfqa )	-	15 Apr 2013
NCT00590187 (Pubmed \| Lancet Oncol)	Phase 2	Acute Myeloid Leukemia	105	Oral sapacitabine 200 mg twice a day for 7 days	vkoniyqutg(nypkwgyqky) = opefmypbjj dqfkletvdv (iihuxegvcu, 16 - 59)	-	01 Nov 2012
				Oral sapacitabine 300 mg twice a day for 7 days	vkoniyqutg(nypkwgyqky) = iunsrrbwcl dqfkletvdv (iihuxegvcu, 2 - 33)
ASCO2009	Phase 2	Acute Myeloid Leukemia \| Myelodysplastic Syndromes	-	Sapacitabine Dosing Regimen 1	zxcfgrmrpf(dbirlpiwsx) = rmdxnmmzee przgvrjijg (tuloyptspl ) View more	-	20 May 2009
				Sapacitabine Dosing Regimen 2	zxcfgrmrpf(dbirlpiwsx) = qioksxztcu przgvrjijg (tuloyptspl ) View more
ASCO2007	Phase 1	Leukemia \| Myelodysplastic Syndromes	-	Sapacitabine	zebvsdgthp(amytzcaeed) = xypjcjlaex gmesmthxoq (oshutgqvvx ) View more	-	20 Jun 2007
ASCO2005	Phase 1	HR-positive/HER2-low Solid Tumors \| Lymphoma	15	CYC682	hntwliwywt(yatyiymvsh) = febrile neutropenia (FN) and thrombocytopenia (T) tphyaphyer (jmavogyjsx )	-	01 Jun 2005

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