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A Phase II Open Label Study With OHR/AVR118 in Anorectic Patients With Recurrent or Advanced Malignancies

Phase 2
18 Years
85 Years
Open (Enrolling)
Anorexia, Cancer Cachexia

Thank you

Trial Information

A Phase II Open Label Study With OHR/AVR118 in Anorectic Patients With Recurrent or Advanced Malignancies

Advanced cancers are usually debilitating. There are few treatments available for symptoms
of advanced cancers like loss of appetite, decreased strength, fatigue, and change in mood.
This Phase II, open label study with OHR/AVR118 will enable the Sponsor to gather data on
safety and efficacy of OHR/AVR118 in the patient population with anorexia-cachexia. Patients
aged 18-85 with advanced cancers (excluding central nervous system [CNS] cancers) who may or
may not be receiving chemotherapy, may be eligible to participate. The study drug, 4.0 mL,
will be given subcutaneously each day for 28 days. Patients who respond to the trial period
dosing will be eligible to continue on OHR/AVR118 if they and their physicians believe it
would be beneficial, and if no safety concerns are raised.

Inclusion Criteria:

- Histologically confirmed solid tumor cancer, leukemia, lymphoma, or multiple myeloma.

- Concurrent anti-cancer treatment, such as chemotherapy or radiation therapy is
permitted except for neo-adjuvant or adjuvant programs.

- Between the ages of 18-85.

- Symptoms of recurrent or metastatic cancer in which anorexia is a predominant
symptom, not necessarily associated with cachexia, and are not attributed to anemia,
concomitant illnesses, or obstruction or loss of organ function.

- Karnofsky performance status of 40%

- Palliative Prognostic Score (PaP) of less than 6

- Patient is expected to be able to remain on a study protocol for two months.

- Pretreatment laboratory data within 7 days of enrollment:

- Hemoglobin >8.5 g/dL , or on stable doses (hematocrit stable within 1 gram and dose
stable for one month) of erythropoietin or similar medication.

- Absolute neutrophil count (ANC) 1,500/mm3.

- Platelets 50,000/mm3.

- Total bilirubin 2.0

- ALT and AST 2.5 times the ULN, or, if the patient has liver metastases, 5 times the

- Creatinine 1.5 mg/dL.

- Normal TSH

- Testosterone levels determined.

- Voluntary written informed consent before performance of any study-related procedure
that is not part of normal medical care.

- Ability to self-administer subcutaneous medication if an assistant or nurse is not
available, and to keep a compliance journal documenting injections at home.

- If on an antidepressant, the dose must have been stabilized for at least 30 days.

- Female patient is post-menopausal, surgically sterilized, or willing to use
acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine
device, diaphragm with spermicide, or condom with spermicide, or abstinence) for the
duration of the study.

- Male patient agrees to use an acceptable barrier method for contraception during the

Exclusion Criteria:

- Patient has uncontrolled brain metastases or central nervous system disease.

- Patient has mechanical, non-reversible reason for not being able to eat, or have a
potential for developing malignant bowel obstruction during the course of the
induction phase of treatment, or patients requiring a PEG for obstruction.

- Patient has had any major surgery within four weeks of enrollment.

- Patient has an uncontrolled concomitant illness including, but not limited to,
ongoing or active infection, symptomatic congestive heart failure, unstable angina
pectoris, or cardiac arrhythmia.

- In the Investigator's opinion, potentially interfere with the completion of treatment
according to this protocol.

- Female patient is pregnant or breast-feeding.

Type of Study:


Study Design:

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

Outcome Measure:

Alleviation of multiple cachexia symptoms

Outcome Description:

Functional Status/Quality of Life as assessed by Simmonds Functional Assessment (SFA); Appetite and early satiety as assesed by patetient-generated subjective global assessment (PG-SGA), Edmonton Symptom assessment Scale (ESAS) and dyspepsia symptom severity index (DSSI); weight gain; increase in lean body mass.

Outcome Time Frame:

Four weeks

Safety Issue:


Principal Investigator

Martin Chasen, MBChB

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ottawa Hospital Cancer Centre


Canada: Health Canada

Study ID:




Start Date:

September 2010

Completion Date:

February 2013

Related Keywords:

  • Anorexia
  • Cancer Cachexia
  • Cancer Cachexia
  • Anorexia
  • Advanced Malignancies
  • Weight Loss
  • Fatigue
  • Karnofsky
  • C-Reactive Protein
  • Simmonds Functional Assessment
  • Anorexia
  • Cachexia