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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.

Study to assess the efficacy and safety of a PARP inhibitor for the treatment of BRCA-positive advanced ovarian cancer

NCT ID

Patient Level Data

Therapeutic Area

AstraZeneca Clinical Trial Information – Outside US

Research Site

A Phase II open-label, non-comparative, international, multicentre study to assess the efficacy and safety of KU 0059436 given orally twice daily in patients with advanced BRCA1  or BRCA2 associated ovarian cancer

Number of patients with confirmed best RECIST response of complete response (CR) or partial response (PR).  Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.

Age Continuous

Sex: Female, Male

BRCA1 or BRCA2 mutations known to cause loss of gene function (clinical deleterious or suspected deleterious mutations).

BRCA mutation

Study Specific Characteristic

PP Analysis Set

ITT Analysis Set

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease from baseline in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

PP Analysis Set (includes all enrolled patients who complete the trial schedule and medication regime without any major deviations to the protocol - this is the main analysis population, with ITT used to confirm)

Confirmed objective tumour response (according to Response Evaluation Criteria In Solid Tumors (RECIST)

Clinical Benefit (CB) is defined as the percentage of patients with a RECIST tumour response of confirmed complete response, partial response or stable disease for ≥8 weeks)

Clinical Benefit (CB)

PP Analysis Set (includes all enrolled patients who complete the trial schedule and medication regime without any major deviations to the protocol - this is the main analysis population, with ITT used to confirm

Duration of response

The best % change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).

Best percentage change in tumour size

Progression-Free Survival (PFS) is defined as the time from first dose to the earlier date of radiologic progression (as per RECIST criteria) or death by any cause in the absence of objective progression.

Progression-Free Survival (PFS)

Overall Study

Two cohorts of women with Breast Cancer gene 1 (BRCA1)- or BRCA2-associated ovarian cancer who had failed at least one prior chemotherapy in the advanced/metastatic setting, were planned to receive olaparib 100 mg bd (n= up to 24) or 400 mg bd (n= up to 40).  Enrolment to  2 cohorts was sequential with the 400 mg bd cohort being recruited first.

Arms	Assigned Interventions
Experimental: KU-0059436 (AZD2281) 100 mg BID	Drug: KU-0059436 (AZD2281)(PARP inhibitor) oral Other Name: Olaparib
Experimental: KU-0059436 (AZD2281) 400 mg BID	Drug: KU-0059436 (AZD2281)(PARP inhibitor) oral

Study to assess the efficacy and safety of a PARP inhibitor for the treatment of BRCA-positive advanced ovarian cancer - ICEBERG 2

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

AstraZeneca Clinical Trial Information – Outside US

US and Canada Only

CSR_Synopsis_D0810C00009(KU36-58).pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator