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Clinical Trials

Date: 2013-05-16

Type of information: Presentation of results at a congress

phase: 2

Announcement: presentation of new Phase II data at the American Society of Clinical Oncology (ASCO) Congress in Chicago on 31 May to 4 June

Company: AstraZeneca (UK)

Product: olaparib

Action mechanism:

PARP inhibitor. 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: ovarian cancer

Therapeutic area: Cancer - Oncology

Country:

Trial details:

The Phase II study is a randomised, double-blind clinical trial to evaluate the efficacy of olaparib maintenance therapy compared to placebo in high grade platinum-sensitive relapsed serous ovarian cancer patients. The pre-planned subgroup analysis retrospectively evaluated patients with confirmed gBRCA mutation status and tBRCA mutation status from archival tumour samples. Results from the full study population were first presented at ASCO in 2011.

Latest news:

* On May 16, 2013, AstraZeneca has announced that it will be moving three of its cancer compounds forward to Phase III clinical development that it will present new Phase II data for olaparib, its investigational oral poly ADP ribose polymerase (PARP) inhibitor, at the American Society of Clinical Oncology (ASCO) Congress in Chicago on 31 May to 4 June, demonstrating its potential as a maintenance treatment for platinum-sensitive relapsed ovarian cancer patients with BRCA gene mutations. Based on these data, AstraZeneca is planning to move olaparib forward to Phase III clinical trials for this patient population in the second half of 2013.
Olaparib features in an oral presentation (abstract # 5505 for maintenance therapy of relapsed platinum-sensitive ovarian cancer) and five poster discussions (abstract # 4013 in gastric cancer; abstract # 2514 in BRCA1/2 mutation positive breast and ovarian cancer; abstract # 11024 as a monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation; abstract # 2579 in advanced solid tumors and abstract # 2581 in EGFR-mutation positive patients with advanced non small cell lung cancer).

Is general: Yes