Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer (NSCLC)

Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer (NSCLC)

A 2-Part Phase 2 Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy

The purpose of this study is to estimate and compare the objective response rate of SPI-1620 administered in combination with docetaxel in patients with NSCLC and to determine the safety of SPI-1620 when administered in combination with docetaxel.

This will be a two part study. In Single Arm Part, patients will receive 11 μg/m2 of SPI-1620 IV followed by docetaxel 75 mg/m2 IV. Cycles will continue every 3 weeks until progression or intolerable toxicity. Overall 27 patients will be enrolled in the Single Arm Part. If 6 or more responses (CR/PR) are observed in this group then the Randomized Part will be initiated. In the Randomized Part approximately 200 patients (100 per arm) will be randomized to receive SPI-1620 plus docetaxel or docetaxel alone. In the experimental arm, patients will receive 11 μg/m2 of SPI-1620 IV followed by docetaxel 75 mg/m2 IV administered in 3-week cycles until progression or intolerable toxicity. In the control arm, patients will receive 75 mg/m2 docetaxel in 3-week cycles until progression or intolerable toxicity.

Patients will receive 11 μg/m2 of SPI-1620 IV followed by docetaxel 75 mg/m2 IV. Cycles will continue every 3 weeks until progression or intolerable toxicity.

Patients will receive 11 μg/m^2 of SPI-1620 intravenous (IV) followed by docetaxel 75 mg/m^2 IV administered in 3-week cycles until progression or intolerable toxicity.

Patients will receive 75 mg/m^2 docetaxel in 3-week cycles until progression or intolerable toxicity.

To estimate and compare the objective response rate of SPI-1620 administered in combination with docetaxel in patients with NSCLC

Periodic physical examinations with vital sign monitoring, safety laboratories and monitoring of adverse events will be performed.

Inclusion Criteria: Histologically or cytologically confirmed locally advanced or metastatic NSCLC that has failed one prior platinum-containing chemotherapy Measurable disease as per RECIST v. 1.1 Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 Adequate bone marrow, liver and renal function Exclusion Criteria: More than one prior chemotherapy regimen for metastatic NSCLC Known, uncontrolled central nervous system (CNS) metastases Significant circulatory disorders in the past 6 mo. Concomitant treatment with phosphodiesterase inhibitors Uncontrolled orthostatic hypotension, asthma or chronic obstructive pulmonary disease (COPD)