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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: October 31, 2014
Last verified: October 2014
  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 ]

Enrollment: 192
Study Start Date: June 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: January 2013 (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:
  • CBDCA
  • Paraplatin®
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: KU36-96, D0810C00004
Study First Received: August 13, 2007
Last Updated: October 31, 2014
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
Adnexal Diseases
Breast Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Skin Diseases
Urogenital Neoplasms
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014