Trial Information
A Phase I, Open Label, Study of the Safety and Tolerability of KU-0059436 and Dacarbazine in the Treatment of Patients With Advanced Solid Tumours
Inclusion Criteria:
- Patients must have:
1. Unresectable stage 3 or stage 4 cutaneous melanoma or unknown primary melanoma
with metastases.
2. Histological or cytological confirmation of melanoma. Histological confirmation
of melanoma from the primary site will suffice, unless the primary site is
unknown.
Exclusion Criteria:
- Previous treatment with cytotoxic chemotherapy for advanced melanoma, apart from
treatment for melanoma with isolated limb perfusion.
- Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or use
of other investigational agents within 4 weeks prior to trial entry (or a longer
period depending on the defined characteristics of the agents used).
- Major surgery within 4 weeks of starting the study.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 in combination with dacarbazine.
Outcome Time Frame:
assessed every 3 weeks
Safety Issue:
No
Principal Investigator
Prof James Carmichael, BSc MBChB MD FRCP
Investigator Role:
Study Director
Investigator Affiliation:
KuDOS Pharmaceuticals Ltd
Authority:
United States: Food and Drug Administration
Study ID:
KU36-73
NCT ID:
NCT00516802
Start Date:
January 2007
Completion Date:
January 2009
Related Keywords:
- Melanoma Neoplasms
- Poly(ADP ribose) polymerases
- dacarbazine
- Neoplasms
- Melanoma
Name | Location |
Research Site |
Allentown, Pennsylvania |