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Clinical Trials

Date: 2013-09-04

Type of information: Recruitment of the first patient

phase: 3

Announcement: recruitment of the first patient

Company: AstraZeneca (UK)

Product: olaparib

Action mechanism:

Olaparib is an investigational oral poly ADP ribose polymerase (PARP) inhibitor. Olaparib is an innovative, potential first-in-class oral poly ADP ribose polymerase (PARP) inhibitor that exploits DNA repair pathway deficiencies to preferentially kill cancer cells. This mode of action gives olaparib the potential for activity in a range of tumour types with DNA repair deficiencies. PARP is associated with a range of tumour types, in particular with breast and ovarian cancers.

Disease: BRCA mutated ovarian cancer

Therapeutic area: Cancer - Oncology

Country:

Trial details:

The SOLO 1 study is being conducted in collaboration with the Gynecologic Oncology Group and the SOLO 2 study with the European Network of Gynaecological Oncological Trial Groups. Both trials are randomised, double blind, placebo controlled studies that utilise the tablet formulation of olaparib at a dose of 300mg twice daily.
The SOLO 1 trial looks at olaparib as a maintenance monotherapy in patients with BRCA mutated ovarian cancer following first line platinum based chemotherapy. The aim of the trial is to determine the benefit of olaparib maintenance monotherapy (compared to placebo) in patients with BRCA mutated high risk ovarian cancer who are in clinical complete response or partial response following first line platinum based chemotherapy, by assessment of progression free survival. Patients must have completed first line platinum based chemotherapy to qualify for the trial. SOLO 1 (GOG-3004) is in collaboration with the Gynecologic Oncology Group. (NCT01844986).
The SOLO 2 trial looks at olaparib as a maintenance monotherapy in patients with BRCA mutated platinum sensitive relapsed ovarian cancer. The aim of the trial is to determine the benefit of olaparib maintenance monotherapy (compared to placebo) in patients with BRCA mutated relapsed ovarian cancer that are in complete or partial response following platinum based chemotherapy, by assessment of progression free survival. Patients must have completed at least two lines of platinum based chemotherapy to qualify for the trail. SOLO 2 (ENGOT-Ov21) is in collaboration with the European Network of Gynaecological Oncological Trial Groups. (NCT01874353).

Latest news:

* On September 4, 2013, AstraZeneca has announced enrollment of the first patient in the Phase III clinical programme for olaparib, an innovative oral poly ADP ribose polymerase (PARP) inhibitor being investigated for the treatment of BRCA mutated ovarian cancer. The Phase III SOLO (Study of OLaparib in Ovarian cancer) programme is designed to determine the benefit, by progression free survival, of olaparib as a maintenance monotherapy in BRCA mutated ovarian cancer patients who are in complete or partial response following platinum-based chemotherapy in the first line setting (SOLO 1), and in the relapsed setting (SOLO 2). The initiation of these studies is based on the subgroup analysis by BRCA mutation status of the Phase II maintenance study in relapsed ovarian cancer, announced at the American Society of Clinical Oncology (ASCO) 2013 Congress, which demonstrated olaparib’s potential as a maintenance treatment for platinum-sensitive relapsed patients with BRCA mutated ovarian cancer.
As a result of the initiation of this programme, the pre-tax impairment charge of $285 million, which was incurred in December 2011 following the decision not to progress olaparib into phase III development, will be reversed in the third quarter of 2013. The reversal of this impairment charge will be excluded from Core earnings per share.
Simultaneously Myriad Genetics has announced that it has entered into an expanded, nonexclusive global collaboration agreement with AstraZeneca to provide companion diagnostics for the olaparib Phase 3 clinical development program.

Is general: Yes