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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Malignant Solid Tumors

Thank you

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

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