Study of Palifosfamide-tris in patients with Small Cell Lung Cancer
Research type
Research Study
Full title
A Multi-center, Open-Label, Adaptive, Randomized Study of Palifosfamide-tris, a Novel DNA Crosslinker, in Combination with Carboplatin and Etoposide (PaCE) Chemotherapy versus Carboplatin and Etoposide (CE) Alone in Chemotherapy Naïve Patients with Extensive-Stage Small Cell Lung Cancer. The MATISSE Study
IRAS ID
101170
Contact name
Yvonne Summers
Sponsor organisation
ZIOPHARM Oncology, Inc.
Eudract number
2011-006134-17
Clinicaltrials.gov Identifier
Research summary
PHASE 3 STUDY TO EVALUATE HOW EFFECTIVE PALIFOSFAMIDE-TRIS IS (STUDY MEDICATION) IN PATIENTS WITH SMALL CELL LUNG CANCER (SCLC) The main purpose of this study is to see if the combination of palifosfamide-tris (study medication) with carboplatin and etoposide (standard treatment) can extend the length of time that the patient??s SCLC disease remains stable and does not get worse. This will be done by comparing the study treatment to carboplatin and etoposide alone, in patients with SCLC who have not received initial cancer treatment before. Eligible participants will be put in either of the treatment groups by chance, like flipping a coin. Half of the participants will receive etoposide, carboplatin and Palifosfamide-tris, and half will receive etoposide and carboplatin only. Both the participants and the study team will know what combination of medication they will be taking. The results will then be compared to see if one the treatments is better. The participants will receive treatment in cycles. Each cycle is 3 weeks long. If the disease remains the same or gets better, the participants can remain in the study and receive treatment for up to 6 cycles. Participants who discontinue from treatment for any reason will be followed by the study team for collection of information related to the progression of the disease and the quality of life through questionnaires and post-treatment medications every 12 weeks for a minimum of 1 year following the completion of enrollment, unless the participant wishes to withdraw consent from the study. This study will be conducted in approximately 100 centres across North America, EU and Asia-pacific. A maximum of 548 participants (274 subjects/ treatment arm) will be enrolled in this study. During the study, the participants will undergo a number of procedures including physical examination, scans, blood and urine tests etc.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
12/NW/0431
Date of REC Opinion
30 Jul 2012
REC opinion
Further Information Favourable Opinion