Trial Information
A Phase I, Open-Label, Study of the Safety and Tolerability of KU-0059436 and Topotecan in the Treatment of Patients With Advanced Solid Tumours
Inclusion Criteria:
- Histological or cytological diagnosis of advanced solid tumour for which no suitable
effective therapy exists;
- Evaluable disease
- Adequate bone marrow, hepatic and renal function
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
- Heavily pre treated patient > 2 previous chemotherapy regimens for metastatic disease
- Co-existing active infection
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 topotecan
Outcome Time Frame:
assessed at each visit
Safety Issue:
No
Principal Investigator
James Cassidy
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beaston Oncology Centre, Glasgow, UK
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
KU36-93
NCT ID:
NCT00516438
Start Date:
July 2007
Completion Date:
November 2009
Related Keywords:
- Malignant Solid Tumors
- malignant solid tumours
- Poly(ADP ribose)
- polymerases
- Neoplasms