A Study of Aneustat (OMN54) in Patients With Advanced Cancer and Lymphomas

NCT01555242 | Completed Phase 1

• 1 other identifier: OMN54-101
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms

Keywords

Advanced Cancer; Lymphoma; Refractory

Outcome Measures

Primary Outcomes (3)

• 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maximum tolerated dose (MTD) is defined as the dose, based on data from 6 patients (or 5 patients if one patient has withdrawn due to non-Aneustat (OMN54) related reasons), below the non-tolerated dose (DL T).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 (2)

• Tumor Response

• Measurement of pathway biomarkers in plasma

Study Arms (1)

Aneustat (OMN54)

EXPERIMENTAL

Drug: Aneustat (OMN54)

Interventions

Aneustat (OMN54) DRUG

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

Aneustat (OMN54)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• AST(SGOT)/ALT(SGPT) ≤ 2.5 x ULN if no liver metastases, AST(SGOT)/ALT(SGPT) \< 5 x ULN if liver metastases
• Bilirubin \< 1.5 x ULN unless Gilbert's Syndrome
• Serum creatinine ≤ 1.25 ULN
• Coagulation within 7 days of Day 1 (initial dose):
• \*INR ≤ 1.5

You may not qualify if:

• 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™).
• Known hypersensitivity to any of the three botanical constituents of Aneustat™ (OMN54), or other similar plants; or to plants belonging to Labiatae or Lamiaceae families, soy, or Aneustat™ (OMN54) excipients
• Use of Sophora subprostrata root (SSR) or herba serissae within 14 days prior to Day 1.

Sponsors & Collaborators

• Omnitura Therapeutics, Inc.: lead

Study Sites (1)

BC Cancer Agency-Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Neoplasms; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 15, 2012
• Study Start: August 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

CA (1)