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:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00516724
First received: August 13, 2007
Last updated: June 18, 2012
Last verified: June 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Triple Negative Metastatic Breast Cancer Advanced Ovarian Cancer Carboplatin Paclitaxel |
Drug: KU-0059436 (AZD2281)(PARP inhibitor) Drug: Carboplatin Drug: Paclitaxel Drug: Paclitaxel + Carboplatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- To identify the dose limiting toxicity of the combination therapy [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 190 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Carboplatin + KU-0059436
|
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
oral
Other Name: Olaparib
Drug: Carboplatin
intravenous injection
Other Names:
|
|
Experimental: 2.
Paclitaxel + KU-0059436
|
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
Oral
Other Name: Olaparib
Drug: Paclitaxel
Intravenous injection
|
|
Experimental: 3.
Paclitaxel, Carboplatin + KU-0059436
|
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
Oral
Other Name: Olaparib
Drug: Paclitaxel + Carboplatin
Intravenous injection
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516724
Locations
| Belgium | |
| Research Site | |
| Brussels, Belgium | |
| Netherlands | |
| Research Site | |
| Amsterdam, Netherlands | |
| Research Site | |
| Rotterdam, Netherlands | |
| United Kingdom | |
| Research Site | |
| Sutton, Surrey, United Kingdom | |
Sponsors and Collaborators
AstraZeneca
Investigators
| 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 |
More Information
No publications provided by AstraZeneca
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00516724 History of Changes |
| Other Study ID Numbers: | D0810C00004, KU36-96 |
| Study First Received: | August 13, 2007 |
| Last Updated: | June 18, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by AstraZeneca:
|
malignant solid tumours Poly(ADP ribose) polymerases |
Additional relevant MeSH terms:
|
Breast Neoplasms Ovarian Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms |
Endocrine System Diseases Gonadal Disorders Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 17, 2013