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

Phase 2

Terminated

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Single Arm Part: SPI-1620 & Docetaxel	SPI-1620	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.
Randomized Part: SPI-1620 & Docetaxel	SPI-1620	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.
Single Arm Part: SPI-1620 & Docetaxel	Docetaxel	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.
Randomized Part: SPI-1620 & Docetaxel	Docetaxel	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.
Randomized Part: Docetaxel	Docetaxel	Patients will receive 75 mg/m\^2 docetaxel in 3-week cycles until progression or intolerable toxicity.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate(ORR) of SPI-1620	Up to 2 years	To estimate and compare the objective response rate of SPI-1620 administered in combination with docetaxel in patients with NSCLC

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DoR)	Up to 12 weeks	only in Randomized Part.
Progression-free survival(PFS)	2 years from the start of study treatment	only in Randomized Part
Overall survival (OS)	2 years from the start of study treatment
Safety of SPI-1620	Up to 2 years	Periodic physical examinations with vital sign monitoring, safety laboratories and monitoring of adverse events will be performed.

Locations (5): The Center for Cancer and Blood Disorders
🇺🇸
Fort Worth, Texas, United States
Virginia Cancer Institute
🇺🇸
Richmond, Virginia, United States
Oncology Hematology Care Inc.
🇺🇸
Cincinnati, Ohio, United States
Tennessee Oncology PLLC
🇺🇸
Chattanooga, Tennessee, United States
Tennessee Oncology
🇺🇸
Nashville, Tennessee, United States