Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00516724

First received: August 13, 2007

Last updated: June 18, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 13, 2007

Last Updated Date

June 18, 2012

Start Date ^ICMJE

June 2007

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with carboplatin.

Change History

Complete list of historical versions of study NCT00516724 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To identify the dose limiting toxicity of the combination therapy [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To identify the dose limiting toxicity of the combination therapy

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel

Official Title ^ICMJE

A Phase I, Open-Label Study to Assess the Safety and Tolerability of KU-0059436 in Combination With Carboplatin, KU-0059436 in Combination With a Paclitaxel/Carboplatin T/C Doublet and KU-0059436 in Combination With Paclitaxel in the Treatment of Patients With Advanced Solid Tumours

Brief Summary

The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with carboplatin and/or Paclitaxel chemotherapy

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Triple Negative Metastatic Breast Cancer
Advanced Ovarian Cancer
Carboplatin
Paclitaxel

Intervention ^ICMJE

Drug: KU-0059436 (AZD2281)(PARP inhibitor)
oral

Other Name: Olaparib
Drug: Carboplatin
intravenous injection
Other Names:
- CBDCA
- Paraplatin®
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
Oral

Other Name: Olaparib
Drug: Paclitaxel
Intravenous injection
Drug: Paclitaxel + Carboplatin
Intravenous injection

Study Arm (s)

Experimental: 1
Carboplatin + KU-0059436
Interventions:
- Drug: KU-0059436 (AZD2281)(PARP inhibitor)
- Drug: Carboplatin
Experimental: 2.
Paclitaxel + KU-0059436
Interventions:
- Drug: KU-0059436 (AZD2281)(PARP inhibitor)
- Drug: Paclitaxel
Experimental: 3.
Paclitaxel, Carboplatin + KU-0059436
Interventions:
- Drug: KU-0059436 (AZD2281)(PARP inhibitor)
- Drug: Paclitaxel + Carboplatin

Publications *

Shamseddine AI, Farhat FS. Platinum-based compounds for the treatment of metastatic breast cancer. Chemotherapy. 2011;57(6):468-87. Epub 2012 Jan 10.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

190

Estimated Completion Date

August 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female patients with a histologically or cytologically diagnosed malignant solid tumour
Adequate bone marrow, hepatic and renal function
Performance status of no more than 2 ( ECOG scale).

Exclusion Criteria:

Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry
Major surgery with 4 weeks of entering the study and must have recovered from effects of the major surgery
More than two previous courses of platinum-containing chemotherapy
Heavily pre-treated patients(> 2 courses of previous chemotherapy and/or extensive irradiation leading to bone marrow deficiency) will be excluded from the study

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, Netherlands, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00516724

Other Study ID Numbers ^ICMJE

D0810C00004, KU36-96

Has Data Monitoring Committee

Responsible Party

AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Jane Robertson, BSc, MBCHB, MD	AstraZeneca
Principal Investigator:	Dr Johann de Bono, MD	Cancer Research UK, The Institute of Cancer Research, London, UK
Principal Investigator:	Prof Jan HM Schellens	The Netherlands Cancer Institute, Amsterdam, The Netherlands

Information Provided By

AstraZeneca

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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