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

Non Small Cell Lung Cancer (NSCLC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01741155
• Other study ID #: SPI-1620-12-201
• Status: Terminated
• Phase: Phase 2
• Start date: May 2013
• Est. completion date: July 2015

Study information

• Verified date: October 2021
• Source: Spectrum Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer (NSCLC)

Intervention

Drug:
• SPI-1620
SPI-1620 11 µg/m2 administered intravenously over one minute.
• Docetaxel
Docetaxel: 75 mg/m2 administered as IV infusion.

Locations

Country	Name	City	State
United States	Tennessee Oncology PLLC	Chattanooga	Tennessee
United States	Oncology Hematology Care Inc.	Cincinnati	Ohio
United States	The Center for Cancer and Blood Disorders	Fort Worth	Texas
United States	Tennessee Oncology	Nashville	Tennessee
United States	Virginia Cancer Institute	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of Response (DoR)	only in Randomized Part.	Up to 12 weeks
Secondary	Progression-free survival(PFS)	only in Randomized Part	2 years from the start of study treatment
Secondary	Overall survival (OS)		2 years from the start of study treatment
Secondary	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