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
- Patients must have:
1. Unresectable stage 3 or stage 4 cutaneous melanoma or unknown primary melanoma
2. Histological or cytological confirmation of melanoma. Histological confirmation
of melanoma from the primary site will suffice, unless the primary site is
- 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:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Prof James Carmichael, BSc MBChB MD FRCP
KuDOS Pharmaceuticals Ltd
United States: Food and Drug Administration
- Melanoma Neoplasms
- Poly(ADP ribose) polymerases