Status:
UNKNOWN
Open Label Study With OHR/AVR118 in Advanced Cancer Patients With Anorexia-Cachexia
Lead Sponsor:
Ohr Pharmaceutical Inc.
Conditions:
Anorexia
Cancer Cachexia
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
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 prev...
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, op...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01206335
Start Date
September 1 2010
End Date
February 1 2013
Last Update
November 27 2012
Active Locations (1)
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1
Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6