A Phase 2 Study of Kevetrin in Subjects With Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      Cellceutix has developed Kevetrin (thioureidobutyronitrile), belonging to an
      anti-proliferative p53 activator pharmacological class, for the treatment of cancer.
      Nonclinical studies have demonstrated that Kevetrin induces apoptosis by activation of wild
      type p53 and induces apoptosis in mutant p53 cells by degradation of oncogenic mutant p53.

      In this Phase 2 study, two different short-term treatment regimens of Kevetrin will be
      evaluated for safety, tolerability, changes in biomarkers/objective tumor response, and to
      evaluate the pharmacokinetics of Kevetrin when administered to subjects with
      platinum-resistant/refractory ovarian cancer.
    

Detailed description: 
      This is an open label, dose-escalation trial to study the safety, biomarker changes
      (including modulation of p53), objective tumor response changes, and pharmacokinetics
      following administration of two different treatment regimens of Kevetrin over a 3-week period
      to subjects with platinum-resistant/refractory ovarian cancer. Following the 3 weeks of
      Kevetrin dosing, subjects are to be followed up for 3 weeks after completion of Kevetrin
      treatment. Standard of care treatment, as medically appropriate and per local guidelines,
      outside of this study protocol can commence after the collection of the post-Kevetrin
      treatment biomarker samples (collected on Day 21±1 day). The patient population recruited
      into this study includes those ovarian cancer patients that have platinum
      resistant/refractory disease, defined as disease progression/relapse within 6 months
      following the last administered dose of platinum therapy (resistant), or lack of response or
      disease progression while receiving the most recent platinum based therapy (refractory),
      respectively. Patients may or may not have had additional treatment (e.g., Doxil) prior to
      entry in this study.

      A total of approximately 10 study participants are planned to be enrolled in two cohorts of
      approximately 5 subjects per cohort, with enrollment in a sequential, dose-escalating
      fashion. Investigators and subjects will be aware of the treatment cohort into which they are
      recruiting. Cohort details and the planned doses are:

      Cohort 1 (n=5) Kevetrin Cycle - Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3
      doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses); Follow-up for
      3 weeks after Kevetrin treatment ends Cohort 2 (n=5) Kevetrin Cycle - Kevetrin 350 mg/m2 IV
      per dose every other day (q.o.d.)/ 3 doses per week (1050 mg/m2 per week), for 3 weeks
      (single cycle; total 9 doses); Follow-up for 3 weeks after Kevetrin treatment ends Cohorts 1
      and 2 will be conducted in a sequential fashion, with safety data from cohort 1 evaluated by
      an independent Data Monitoring Committee (DMC). The DMC will make appropriate recommendations
      based on the available safety data as regards the intent of progressing to the higher dose
      cohort 2.
    

Intervention name(s): Kevetrin; Kevetrin
Intervention type(s): Drug; Drug
Intervention description(s): Kevetrin dose to associated cohort; Kevetrin dose to associated cohort
Other intervention name(s): Cohort
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment