Cyclacel Pharmaceuticals has commenced a Phase lb/ll clinical trial to investigate the safety and effectiveness of sapacitabine in combination with olaparib (Lynparza) for the treatment of patients with BRCA mutant breast cancer.
The investigator-sponsored, open-label, single-group assignment trial intends to enrol around 64 patients with breast cancer and BRCA1 or BRCA2 mutation.
In the first part of the two-stage trial, Cyclacel will evaluate the safety and tolerability of escalating doses of the study's drug combination.
The second part of the trial will evaluate the efficacy of the recommended Phase ll dose in 18 patients.
If a pre-specified number of these patients achieve a full or partial response as per RECIST 1.1 criteria, the Phase lb/ll trial will include 28 additional patients.
The Phase lb/ll trial’s primary endpoints include identifying maximum-tolerated dose, recommended Phase ll dose and objective response rate. Its secondary endpoint is progression-free survival.
The trial will be held at Dana-Farber Cancer Institute in partnership with Cyclacel and AstraZeneca, which will provide sapacitabine and Lynparza, respectively.
The trial’s principal investigator Sara Tolaney said: “Despite advancements in the treatment of BRCA positive breast cancer, we are continually searching for ways to improve on the standard of care for this disease which carries a poor prognosis for the majority of individuals.
“PARP inhibitor monotherapy is the current standard of care for breast and ovarian cancers with homologous recombination deficient (HRD) cancers, which include those positive for BRCA mutations.
“The study will help determine if the all-oral combination of sapacitabine and olaparib could provide additional benefit to these patients for whom limited treatment options exist.”
BRCA mutation is a change in either of the BRCA1 and BRCA2 genes, which are capable of suppressing tumours.