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
Overview
- Phase
- Phase 1
- Intervention
- Aneustat (OMN54)
- Conditions
- Neoplasms
- Sponsor
- Omnitura Therapeutics, Inc.
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Maximum Tolerated Dose (MTD) of two dosing regimens (once daily and twice daily)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histological or cytological evidence of malignancy
- •Male or female, 18 years or older
- •Presence of advanced tumours, i.e., measurable or non-measurable disease (RECIST criteria, version 1.1)that have recurred or progressed following standard therapy
- •Able to swallow the oral capsule form of the drug
- •Failed at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy.
- •Haematology within 7 days of Day 1 (initial dose):
- •Hemoglobin (Hb) \> 9.0 g/dL
- •Platelets ≥ 100,000 cells/mm3 (or, ≥100 x 10/L)
- •Absolute neutrophil count (ANC) \> 1.5 cells x109/L (or, \> 1500 cells/mm3)
- •Chemistry within 7 days of Day 1 (initial dose):
Exclusion Criteria
- •Patient has uncontrolled or symptomatic brain metastases (If a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days prior to Day 1 dosing).
- •Use of an investigational medication or device within 30 days of initiating study therapy (Day 1).
- •Major surgery within 30 days prior to first dose (Day 1).
- •Radiotherapy, chemotherapy, or immunotherapy within 28 days prior to Day 1 (not including palliative radiotherapy at focal sites).
- •Pregnancy or lactation.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NY Heart Association Class III or IV, see Appendix 3), unstable angina pectoris, unstable cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements.
- •Screening (within approximately 28 days of registration) 12-lead electrocardiogram (ECG) that is abnormal and clinically significant
- •Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption.
- •Use of warfarin, i.e., Coumadin®, Jantoven® within 7 days prior to Day 1 (initial dosing)
- •Intolerance or aversion to porcine ingredients that are used for the OMN54 oral capsules in the investigational medicine, OMN54 (Aneustat™).
Arms & Interventions
Aneustat (OMN54)
Intervention: Aneustat (OMN54)
Outcomes
Primary Outcomes
Maximum Tolerated Dose (MTD) of two dosing regimens (once daily and twice daily)
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)
Assessment per Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
Plasma blood concentrations of chemical markers
These measurements are intended to characterize the pharmacokinetics of Aneustat (OMN54)
Secondary Outcomes
- Tumor Response
- Measurement of pathway biomarkers in plasma