Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line to Treat Biliary Cancer

Spectrum Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Biliary Cancer

Treatments: Drug: SPI-1620; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01773785

SPI-1620-12-202

Details and patient eligibility

About

The primary purpose of this study is to determine the effectiveness of SPI-1620 in combination with docetaxel in patients with advanced biliary cancer.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed biliary tract or gallbladder cancer that have relapsed or are refractory after one prior gemcitabine-based chemotherapy regimen for advanced biliary cancer
• Evaluable disease
• ECOG PS ≤ 2
• Adequate bone marrow, liver and renal function

Exclusion criteria

• Treatment with more than one prior chemotherapy regimen
• Known, uncontrolled CNS metastases
• Baseline peripheral neuropathy ≥ grade 2.
• Significant circulatory disorders in the past 6 months
• Concomitant use of phosphodiesterase inhibitors

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

SPI-1620 & Docetaxel

Experimental group

Description:

Patients will receive 11 μg/m2 of SPI-1620 intravenously over one minute. Ten minutes after (±2 min) SPI-1620 administration, patients will receive docetaxel 75 mg/m2 intravenous. This regimen will be repeated every 3-weeks cycles until progression or intolerable toxicity.

Treatment:

Drug: SPI-1620

Drug: Docetaxel