Phase 2 Study of TLK286 in Platinum Resistant Advanced Epithelial Ovarian Cancer

Telik

Status and phase: Completed; Phase 2

Conditions: Ovarian Neoplasms

Treatments: Drug: TLK286

Study type: Interventional

Funder types: Industry

Identifiers

NCT00038428

TLK286.2003

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness and safety of TLK286 given intravenously once every week in the treatment of patients with advanced ovarian cancer that is resistant to platinum-based chemotherapy.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Histologic diagnosis of ovarian cancer
• Recurrent or persistent disease following primary therapy
• Measurable disease
• Prior treatment with at least one but no more than three prior chemotherapy regimens
• Resistant or refractory to platinum-based chemotherapy
• At least 18 years of age
• Good performance status (ECOG 0 to 1)
• Adequate liver, renal and bone marrow function

Exclusion criteria

• Pregnant or currently breast feeding
• Treatment with chemotherapy or immunotherapy within four weeks
• Prior radiation to the whole pelvis

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)