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

Phase 1

Completed

• Conditions: Carboplatin; Triple Negative Metastatic Breast Cancer; Advanced Ovarian Cancer; Paclitaxel
• Interventions: Drug: KU-0059436 (AZD2281)(PARP inhibitor); Drug: Carboplatin; Drug: Paclitaxel; Drug: Paclitaxel + Carboplatin

• Registration Number: NCT00516724
• Lead Sponsor: AstraZeneca

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 available

Study Timeline

• Study Start: 2007-06-22
• Study First Submitted: 2007-08-13
• Study First Submitted QC: 2007-08-13
• Study First Posted: 2007-08-15
• Primary Completion: 2013-01-04
• Status Verified: 2024-04
• Study Completion: 2024-04-11
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3.	KU-0059436 (AZD2281)(PARP inhibitor)	Paclitaxel, Carboplatin + KU-0059436
1	KU-0059436 (AZD2281)(PARP inhibitor)	Carboplatin + KU-0059436
1	Carboplatin	Carboplatin + KU-0059436
2.	KU-0059436 (AZD2281)(PARP inhibitor)	Paclitaxel + KU-0059436
2.	Paclitaxel	Paclitaxel + KU-0059436
3.	Paclitaxel + Carboplatin	Paclitaxel, Carboplatin + KU-0059436

Primary Outcome Measures

Name	Time	Method
To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin	assessed at each visit

Secondary Outcome Measures

Name	Time	Method
To identify the dose limiting toxicity of the combination therapy	assessed at each visit

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom