Head and Neck Squamous Cell Carcinoma Clinical Trial
Official title:
A Phase II Study of Oral Rigosertib in Patients With Relapsed or Metastatic, Platinum-resistant, Human Papillomavirus Positive or Negative Squamous Cell Carcinoma
The primary objective of this study is to determine if tumors in patients with
papillomavirus (HPV) positive or negative squamous cell carcinoma (SCC) that no longer
responds to standard therapy will decrease in size following treatment with the
investigational drug, rigosertib sodium (ON 01910.Na). A secondary objective is to determine
if treatment with rigosertib causes any side effects.
Rigosertib is an investigational drug, which means that it has not been approved by the U.S.
Food and Drug Administration (FDA) to treat any diseases. We are studying rigosertib as a
new anticancer drug. Tests that we have done in the laboratory suggest that rigosertib works
by blocking cell division in cancer cells and causing them to die.
This will be a multicenter, Phase II study to evaluate the safety and efficacy of oral
rigosertib in patients with relapsed or metastatic squamous cell carinoma (SCC) who
previously received platinum-based chemotherapy and/or chemo-radiation therapy.
Only patients with head and neck squamous cell carinoma (HNSCC), non-small cell lung SCC,
skin SCC, cervical SCC, penile SCC, anal SCC or esophageal SCC will be enrolled in the
study.
Patients will be administered rigosertib capsules at a dose of 560 mg BID on days 1 to 14 of
a 21-day cycle. Patients will be enrolled in 2 cohorts based on HPV test results:
- Cohort 1 will include up to 40 patients with human papillomavirus (HPV)-positive SCC,
of which approximately 30 patients will have HNSCC, and approximately 10 patients with
SCC of another origin (eg, cervix, anal, penile);
- Cohort 2 will include up to 40 patients with HPV-negative SCC, of which approximately
30 patients will have HNSCC, and approximately 10 patients with SCC of another origin
(eg, lung, skin, esophageal).
Patients will be evaluated for progression after completing 3 cycles of therapy and every 3
cycles thereafter. Patients with stable disease (SD) or better, based on revised Response
Criteria in Solid Tumors (mRECIST) 1.1, will receive repeated cycles of treatment on a
21-day cycle schedule until disease progression, development of unacceptable toxicity, or
withdrawal of consent. Patients with progressive disease (PD) but who, in the opinion of the
Investigator, appear to be deriving clinical benefit, may continue on study with a planned
disease reassessment after one further cycle of therapy. Should the patient have SD or PR at
this reassessment, s/he may continue on study, with subsequent reassessments every 3 cycles.
Following discontinuation of rigosertib treatment, patients' mortality status will be
assessed every 3 months.
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