Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin
Outcome Time Frame:
assessed at each visit
Safety Issue:
No
Principal Investigator
Jane Robertson, BSc, MBCHB, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
D0810C00004
NCT ID:
NCT00516724
Start Date:
June 2007
Completion Date:
August 2013
Related Keywords:
- Triple Negative Metastatic Breast Cancer
- Advanced Ovarian Cancer
- Carboplatin
- Paclitaxel
- malignant solid tumours
- Poly(ADP ribose) polymerases
- Breast Neoplasms
- Ovarian Neoplasms