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

Spectrum Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Non Small Cell Lung Cancer (NSCLC)

Treatments: Drug: SPI-1620; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01741155

SPI-1620-12-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 3 patient groups

Single Arm Part: SPI-1620 & Docetaxel

Experimental group

Description:

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.

Treatment:

Drug: Docetaxel

Drug: SPI-1620

Randomized Part: SPI-1620 & Docetaxel

Experimental group

Description:

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.

Treatment:

Drug: Docetaxel

Drug: SPI-1620

Randomized Part: Docetaxel

Active Comparator group

Description:

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

Treatment:

Drug: Docetaxel