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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma Neoplasms

Thank you

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 SiteAllentown, Pennsylvania