Open Label Study With OHR/AVR118 in Advanced Cancer Patients With Anorexia-Cachexia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ohr Pharmaceutical Inc.
ClinicalTrials.gov Identifier:
NCT01206335
First received: September 20, 2010
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to determine whether patients with advanced cancers who receive OHR/AVR118 solution for injection into the skin can achieve improvement in quality of life. Based on a previous study in patients with AIDS, possible benefits may include improved appetite and strength; weight gain, improved mood; and decreased fatigue.


Condition Intervention Phase
Anorexia
Cancer Cachexia
Drug: OHR/AVR118
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Open Label Study With OHR/AVR118 in Anorectic Patients With Recurrent or Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by Ohr Pharmaceutical Inc.:

Primary Outcome Measures:
  • Alleviation of multiple cachexia symptoms [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Impact on inflammatory markers and hormonal milieu [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Measurement of effects on Testosterone, TSH and C-Reactive protein


Estimated Enrollment: 20
Study Start Date: September 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OHR/AVR118
Experimental Drug
Drug: OHR/AVR118
OHR/AVR118 given subcutaneously at 4mL per day
Other Name: AVR118

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ULN.
  • 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 study

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206335

Locations
Canada, Ontario
Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ohr Pharmaceutical Inc.
Investigators
Principal Investigator: Martin Chasen, MBChB Ottawa Hospital Cancer Centre
  More Information

No publications provided

Responsible Party: Ohr Pharmaceutical Inc.
ClinicalTrials.gov Identifier: NCT01206335     History of Changes
Other Study ID Numbers: OHR-201
Study First Received: September 20, 2010
Last Updated: November 26, 2012
Health Authority: Canada: Health Canada

Keywords provided by Ohr Pharmaceutical Inc.:
Cancer Cachexia
Anorexia
Advanced Malignancies
Weight Loss
Fatigue
Karnofsky
C-Reactive Protein
Simmonds Functional Assessment

Additional relevant MeSH terms:
Anorexia
Cachexia
Signs and Symptoms, Digestive
Signs and Symptoms
Emaciation
Weight Loss
Body Weight Changes
Body Weight

ClinicalTrials.gov processed this record on July 23, 2014