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: July 23, 2014
Last verified: July 2014

August 13, 2007
July 23, 2014
June 2007
January 2013   (final data collection date for primary outcome measure)
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 ]
To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with carboplatin.
Complete list of historical versions of study NCT00516724 on ClinicalTrials.gov Archive Site
To identify the dose limiting toxicity of the combination therapy [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]
To identify the dose limiting toxicity of the combination therapy
Not Provided
Not Provided
 
Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel
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

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Triple Negative Metastatic Breast Cancer
  • Advanced Ovarian Cancer
  • Carboplatin
  • Paclitaxel
  • Drug: KU-0059436 (AZD2281)(PARP inhibitor)
    oral
    Other Name: Olaparib
  • Drug: Carboplatin
    intravenous injection
    Other Names:
    • CBDCA
    • Paraplatin®
  • Drug: KU-0059436 (AZD2281)(PARP inhibitor)
    Oral
    Other Name: Olaparib
  • Drug: Paclitaxel
    Intravenous injection
  • Drug: Paclitaxel + Carboplatin
    Intravenous injection
  • Experimental: 1
    Carboplatin + KU-0059436
    Interventions:
    • Drug: KU-0059436 (AZD2281)(PARP inhibitor)
    • Drug: Carboplatin
  • Experimental: 2.
    Paclitaxel + KU-0059436
    Interventions:
    • Drug: KU-0059436 (AZD2281)(PARP inhibitor)
    • Drug: Paclitaxel
  • Experimental: 3.
    Paclitaxel, Carboplatin + KU-0059436
    Interventions:
    • Drug: KU-0059436 (AZD2281)(PARP inhibitor)
    • Drug: Paclitaxel + Carboplatin
Shamseddine AI, Farhat FS. Platinum-based compounds for the treatment of metastatic breast cancer. Chemotherapy. 2011;57(6):468-87. doi: 10.1159/000334093. Epub 2012 Jan 10. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
192
December 2014
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Netherlands,   United Kingdom
 
NCT00516724
KU36-96, D0810C00004
No
AstraZeneca
AstraZeneca
Not Provided
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
AstraZeneca
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP