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.

Study Overview

• Status: Terminated
• Conditions: Non Small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: SPI-1620; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care Inc.
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Tennessee Oncology PLLC
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology
  • Texas
    • Fort Worth, Texas, United States, 76104
      • The Center for Cancer and Blood Disorders
  • Virginia
    • Richmond, Virginia, United States, 23230
      • Virginia Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Spectrum Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: November 27, 2012
• First Submitted That Met QC Criteria: December 3, 2012
• First Posted (Estimate): December 4, 2012

Study Record Updates

• Last Update Posted (Actual): October 13, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: SPI-1620-12-201