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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

Phase 1
18 Years
Open (Enrolling)

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Trial Information

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

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.

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):

- 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

- ECOG Performance Status between 0 - 2 and estimated life expectancy of > 3 months.

- Having the initiative and means to be compliant with the protocol (as judged by the
Principal Investigator) and is within a feasible geographical proximity of the study
center to make the required study visits.

- Written informed consent obtained prior to any study screening procedures

- Females of childbearing potential (a female is considered of childbearing potential
unless she is postmenopausal, i.e., no menses for at least 12 consecutive months, or
is without a uterus) must have a negative urine pregnancy test (UPT) within 7 days of
Day 1 (initial dose)

- Females of childbearing potential must agree to use an effective method of
contraception (i.e., sexual abstinence, condoms, intrauterine device, diaphragm) from
Screening period and throughout study participation.

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

- Use of warfarin, i.e., Coumadin®, Jantoven® within 7 days prior to Day 1 (initial

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) of two dosing regimens (once daily and twice daily)

Outcome Description:

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).

Safety Issue:



Canada: Health Canada

Study ID:




Start Date:

August 2012

Completion Date:

August 2013

Related Keywords:

  • Neoplasms
  • Advanced Cancer
  • Lymphoma
  • Refractory
  • Neoplasms
  • Lymphoma