A Study of Aneustat (OMN54) in Patients With Advanced Cancer and Lymphomas
This is a phase I, open-label, multiple dose, dose escalation study to assess the safety, tolerability and pharmacokinetics of Aneustat™ (OMN54), a novel therapy, administered orally in patients with advanced cancer and lymphomas.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Open-Label, Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Aneustat™ (OMN54) Administered on a Daily Oral Regimen in Patients With Advanced Cancer and Lymphomas|
- Maximum Tolerated Dose (MTD) of two dosing regimens (once daily and twice daily) [ Designated as safety issue: Yes ]The maximum tolerated dose (MTD) is defined as the dose, based on data from 6 patients (or 5 patients if one patient has withdrawn due to non-Aneustat (OMN54) related reasons), below the non-tolerated dose (DL T).
- Dose Limiting Toxicity (DLT) of two dosing regimens (once daily and twice daily) [ Designated as safety issue: Yes ]Assessment per Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
- Plasma blood concentrations of chemical markers [ Designated as safety issue: No ]These measurements are intended to characterize the pharmacokinetics of Aneustat (OMN54)
- Tumor Response [ Designated as safety issue: No ]Tumor response as per RECIST criteria version 1.1, and tumor markers in plasma, as applicable
- Measurement of pathway biomarkers in plasma [ Designated as safety issue: No ]Plasma concentrations of cancer-related proteins to help characterize Aneustat (OMN54) activity
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
|Experimental: Aneustat (OMN54)||
Drug: Aneustat (OMN54)
100 mg active/capsule; oral administration; 28 days/cycle (up to 6 cycles total) 1,000 mg QD 2,000 mg QD 1,500 mg BID 2,000 mg BID 2,500 mg BID
Patients who complete a 28-day cycle, may be eligible to continue receiving Aneustat™ (OMN54) in 4-week increments for up to 6 cycles (inclusive of cycle 1) if further treatment is judged to be of possible benefit; if patient has not experienced unacceptable toxicity; and no study withdrawal criteria has been met.