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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Advanced Ovarian Cancer; Paclitaxel; Carboplatin; Triple Negative Metastatic Breast Cancer

Treatments: Drug: KU-0059436 (AZD2281)(PARP inhibitor); Drug: Paclitaxel + Carboplatin; Drug: Paclitaxel; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00516724

2007-000939-26 (EudraCT Number)

D0810C00004

KU36-96

Details and patient eligibility

About

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.

Enrollment: 189 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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189 participants in 3 patient groups

1

Experimental group

Description:

Carboplatin + KU-0059436

Treatment:

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

Drug: Carboplatin

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

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

2.

Experimental group

Description:

Paclitaxel + KU-0059436

Treatment:

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

Drug: Paclitaxel

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

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

3.

Experimental group

Description:

Paclitaxel, Carboplatin + KU-0059436

Treatment:

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

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

Drug: Paclitaxel + Carboplatin

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