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

Sponsor
AstraZeneca (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT00516724
Collaborator
(none)
189
4
3
186.3
47.3
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: KU-0059436 (AZD2281)(PARP inhibitor)
  • Drug: Carboplatin
  • Drug: KU-0059436 (AZD2281)(PARP inhibitor)
  • Drug: Paclitaxel
  • Drug: KU-0059436 (AZD2281)(PARP inhibitor)
  • Drug: Paclitaxel + Carboplatin
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
189 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Actual Study Start Date :
Jun 22, 2007
Actual Primary Completion Date :
Jan 4, 2013
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Carboplatin + KU-0059436

Drug: KU-0059436 (AZD2281)(PARP inhibitor)
oral
Other Names:
  • Olaparib
  • Drug: Carboplatin
    intravenous injection
    Other Names:
  • CBDCA
  • Paraplatin®
  • Experimental: 2.

    Paclitaxel + KU-0059436

    Drug: KU-0059436 (AZD2281)(PARP inhibitor)
    Oral
    Other Names:
  • Olaparib
  • Drug: Paclitaxel
    Intravenous injection

    Experimental: 3.

    Paclitaxel, Carboplatin + KU-0059436

    Drug: KU-0059436 (AZD2281)(PARP inhibitor)
    Oral
    Other Names:
  • Olaparib
  • Drug: Paclitaxel + Carboplatin
    Intravenous injection

    Outcome Measures

    Primary Outcome Measures

    1. To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin [assessed at each visit]

    Secondary Outcome Measures

    1. To identify the dose limiting toxicity of the combination therapy [assessed at each visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 130 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Research Site Brussels Belgium 1090
    2 Research Site Amsterdam Netherlands 1066 EC
    3 Research Site Rotterdam Netherlands 3015
    4 Research Site London United Kingdom SM2 5NG

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00516724
    Other Study ID Numbers:
    • KU36-96
    • D0810C00004
    First Posted:
    Aug 15, 2007
    Last Update Posted:
    Jun 3, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by AstraZeneca
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 3, 2022