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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Non Small Cell Lung Cancer (NSCLC)

Intervention / Treatment
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* Drug: SPI-1620
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm Part: SPI-1620 & Docetaxel<br>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. | Drug: SPI-1620<br>* SPI-1620 11 μg/m2 administered intravenously over one minute.<br>Drug: Docetaxel<br>* Docetaxel: 75 mg/m2 administered as IV infusion.<br>* Other names: Taxotere;|
| Experimental: Randomized Part: SPI-1620 & Docetaxel<br>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. | Drug: SPI-1620<br>* SPI-1620 11 μg/m2 administered intravenously over one minute.<br>Drug: Docetaxel<br>* Docetaxel: 75 mg/m2 administered as IV infusion.<br>* Other names: Taxotere;|
| Active Comparator: Randomized Part: Docetaxel<br>Patients will receive 75 mg/m^2 docetaxel in 3-week cycles until progression or intolerable toxicity. | Drug: Docetaxel<br>* Docetaxel: 75 mg/m2 administered as IV infusion.<br>* Other names: Taxotere;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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