ZIOPHARM Oncology, a biopharmaceutical company, has announced that the first patient has been dosed in the Multicenter Adaptive Trial Investigating Small cell lung cancer Survival Endpoints (MATISSE) study of palifosfamide to treat small cell lung cancer (SCLC).
Palifosfamide (ZIO-201) is a novel DNA-targeted cancer treatment that bypasses drug resistance mediated by ALDH (aldehyde dehydrogenase), an enzyme associated with cancer stem cells.
ZIOPHARM medical advisory board member, ASCO former president, Lance Armstrong Foundation oncology chair and professor at the Simon Cancer Center of Indiana University Medical Center, Lawrence Einhorn, said palifosfamide has demonstrated broad therapeutic activity, including effects against cancer stem cells, as well as good tolerability alone and in combination with various chemotherapeutics.
"MATISSE incorporates a novel, adaptive study design that should provide a clinically meaningful understanding of palifosfamide’s activity and tolerability in advanced disease as quickly as possible for this heavily underserved population," Einhorn added.
The Phase 3 multicentre, open-label, adaptive study of palifosfamide will enrol up to 548 chemotherapy-naive patients with extensive-stage small cell lung cancer.
The eligible patients will be randomised, one-to-one, in the MATISSE study to receive either palifosfamide in combination with carboplatin and etoposide (PaCE) or carboplatin and etoposide alone.
Overall survival is the trial’s primary endpoint, while secondary endpoints include progression-free survival, objective response rate and quality of life.
The adaptive design of the study includes a prospectively planned opportunity which allows protocol modification by adjusting one or more specified components of the design to maintain adequate power.
Data from a Phase 3 randomised study of ifosfamide conducted by the Hoosier Oncology Group (HOG) were also incorporated into the efficacy rationale for the MATISSE study.
Ifosfamide demonstrated a survival benefit, the only front-line therapy added to standard of care to do so in SCLC, and excessive toxicities in the HOG study.
Image: Histopathologic image of small cell carcinoma of the lung. Photo courtesy of: KGH.