Drugs / Samuraciclib

Trials 6

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT07645651 Oct 2026 → Jul 2027 expected pancreatic ductal adenocarcinoma University of Washington Recruiting No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT07665684 Jul 2026 → May 2029 expected mucinous adenocarcinoma, pancreatic adenosquamous carcinoma, pancreatic ductal adenocarcinoma University Health Network, Toronto Not yet recruiting No outcome recorded
Phase 1/2 NCT06125522 Jan 2024 → Sep 2026 breast cancer Pfizer Completed No outcome recorded
Phase 1/2 NCT05963997 Oct 2023 → Mar 2026 breast cancer Carrick Therapeutics Limited Completed No outcome recorded
Phase 1/2 NCT04802759 Jun 2021 → May 2029 expected estrogen-receptor positive breast cancer Hoffmann-La Roche Recruiting No outcome recorded
Phase 21 trial
Phase 2 NCT05963984 Nov 2023 → Mar 2025 breast cancer Carrick Therapeutics Limited Completed No outcome recorded

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2025-12-10 Carrick Therapeutics Limited Results Carrick Therapeutics Announces Positive Results from Phase 2 Randomized Trial of Samuraciclib in Combination with Fulvestrant in Patients with Hormone Receptor Positive, HER2 Negative Advanced Breast Cancer carricktherapeutics.com ↗
These Phase 2 trial results show that samuraciclib in combination with fulvestrant provided a very notable and clinically meaningful benefit in a broad patient population with HR positive, HER2 negative metastatic breast cancer whose disease progressed following treatment with a CDK4/6 inhibitor.
2025-05-15 Carrick Therapeutics Limited Results Carrick Therapeutics Announces New Clinical Data Supporting Biomarker-driven Patient Selection for Samuraciclib (CDK7i) in Combination with SERDs in Hormone Receptor Positive Advanced Breast Cancer carricktherapeutics.com ↗
The analysis indicated that study participants with no evidence of a deleterious mutation in the TP53 gene in circulating tumor DNA at baseline or separately, without liver metastases at baseline, experienced extended durations of progression-free survival.
2021-12-09 Carrick Therapeutics Limited Results Carrick Therapeutics Presents Encouraging Clinical Data for Samuraciclib (CT7001) at the 2021 San Antonio Breast Cancer Symposium carricktherapeutics.com ↗
Samuraciclib in combination with fulvestrant in the post CDK4/6 setting has demonstrated a median mPFS of 32 weeks.
2021-09-16 Carrick Therapeutics Limited Results Carrick Therapeutics Presents Encouraging Initial Efficacy for Samuraciclib (CT-7001) in Combination with Fulvestrant in Advanced HR+, HER2- Breast Cancer Patients at ESMO Congress 2021 carricktherapeutics.com ↗
Data presented from a Phase 2a study of samuraciclib in combination with fulvestrant in women with hormone receptor positive (HR+), HER2- advanced breast cancer (BC) previously treated with a CDK4/6 inhibitor (abstract: 1346 (265P)) demonstrated clinical activity and tolerability that supports further clinical development of the combination.
2021-08-16 Carrick Therapeutics Limited Regulatory Carrick Therapeutics Receives FDA Fast Track Designations for Two Samuraciclib Combinations for the Treatment of HR+, HER2 Advanced Breast Cancer and Locally Advanced or Metastatic Triple Negative Breast Cancer carricktherapeutics.com ↗

All press releases naming this drug 14 releases

DateIssuerRelease

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as Samuraciclib ClinicalTrials.gov intervention name — accepted as the source's own label NCT04802759 ↗
5

NCT07665684 ↗

NCT05963997 ↗

NCT07645651 ↗

NCT05963984 ↗

NCT06125522 ↗

Route Oral “360 mg orally once a day” NCT04802759 ↗