Date: 2018-09-10
Type of
information: Initiation of the trial
phase: 1b-2
Announcement: initiation of the trial
Company: Cyclacel Pharmaceuticals (USA - NJ)
Product: sapacitabin and olaparib
Action
mechanism:
- nucleoside analog. Sapacitabine is an oral nucleoside analogue prodrug that acts through a novel mechanism. The compound interferes with DNA synthesis by introducing single-strand DNA breaks leading to arrest of the cell division cycle at G2 phase and development of double-strand DNA breaks.
- poly ADP-ribose polymerase (PARP) inhibitor/enzyme inhibitor. Lynparza™ (olaparib) is an oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells.
- Lynparza™ is the first PARP inhibitor to be approved for patients with germline BRCA-mutated advanced ovarian cancer, and has been launched in the U.S. and Europe. In addition to ovarian cancer, AstraZeneca is investigating the full potential of olaparib in multiple tumour types, with Phase III studies in second line gastric cancer, BRCA-mutated pancreatic cancer and adjuvant and metastatic BRCA-mutated breast cancers underway.
Disease: BRCA mutant breast cancer
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
-
- The investigator-sponsored Phase 1b/2 study will enroll approximately 64 patients with breast cancer and BRCA1 or BRCA2 mutation. The primary endpoints are to determine maximum tolerated dose, recommended Phase 2 dose and objective response rate. Progression-free survival will be assessed as a secondary endpoint. The first of two parts of the study will assess safety and tolerability of escalating doses of the combination. The second part will assess efficacy of the recommended Phase 2 dose in 18 patients. If a prespecified number of these patients achieve a complete or partial response per RECIST 1.1 criteria, the study will be expanded to a further 28 patients. (NCT03641755)
Latest
news:
- • On September 10, 2018, Cyclacel Pharmaceuticals announced the initiation of a Phase 1b/2 investigator-sponsored clinical trial to evaluate the safety and effectiveness of sapacitabine in combination with olaparib in patients with BRCA mutant breast cancer. The trial will be conducted at the Dana-Farber Cancer Institute with collaborators Cyclacel and AstraZeneca providing sapacitabine investigational drug and the approved PARP-inhibitor olaparib (Lynparza®), respectively.
Is
general: Yes
