Clinical trial · Interventional
Open Label Study With OHR/AVR118 in Advanced Cancer Patients With Anorexia-Cachexia
A Phase II Open Label Study With OHR/AVR118 in Anorectic Patients With Recurrent or Advanced Malignancies
NCT01206335CI-TRIAL-00008543unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anorexia | — | UNRESOLVED | — |
| Cancer Cachexia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OHR/AVR118 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OHR/AVR118
- description
- Experimental Drug
- interventionNames
- Drug: OHR/AVR118
Primary outcomes (1)
- measure
- Alleviation of multiple cachexia symptoms
- timeFrame
- Four weeks
- 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.
Secondary outcomes (1)
- measure
- Impact on inflammatory markers and hormonal milieu
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.