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Study of Palifosfamide-tris in Combination With Carboplatin and Etoposide in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer (The MATISSE Study)

NCT01555710 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 548

Last updated 2013-05-21

No results posted yet for this study

Summary

This is a multinational, multicenter, randomized controlled, open-label, adaptive study to evaluate the efficacy of PaCE chemotherapy in chemotherapy naive subjects with extensive-stage SCLC. Eligible subjects will be stratified according to age, gender, and Eastern Cooperative Oncology Group (ECOG) performance status, and randomized in a 1:1 ratio to receive either PaCE or CE chemotherapy.

The study design uses an adaptive group sequential approach with sample size re-estimation at the interim analysis.

Secondary efficacy endpoints include ORR, PFS, duration of response and changes in QOL and disease-related symptoms. Tumor-related endpoints will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines.

The safety of study treatments will be assessed by the frequency and severity of adverse events as determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. To provide an initial confirmation of safety, an early interim analysis of safety data only will be performed.

An independent Data Monitoring Committee (DMC) will be convened to assess the safety and efficacy of the study interventions and to monitor the overall conduct of the clinical trial.

Conditions

  • Extensive-Stage Small Cell Lung Cancer

Interventions

DRUG

Carboplatin

AUC 4 mg/mL/min 1 day every 21 days for a max of 6 cycles.

DRUG

Palifosfamide-tris

130 mg/m2/day 3 days every 21 days for a max of 6 cycles.

DRUG

Etoposide

100 mg/m2/day 3 days every 21 days for a maximum of 6 cycles.

DRUG

Carboplatin

AUC 5 mg/mL/min 1 day every 21 days for a max of 6 cycles.

Sponsors & Collaborators

  • Alaunos Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States
  • Australia
  • Canada
  • France
  • Hungary
  • Israel
  • Italy
  • Poland
  • Russia
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01555710 on ClinicalTrials.gov