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This study will test an experimental drug named TCMCB07 for the treatment of cancer cachexia. Cachexia is a syndrome characterized by weight loss, anorexia, weakness or lack of energy, and anemia. Cachexia occurs in many cancers, usually at the advanced stages of disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCMCB07 | Experimental | once daily subcutaneous injection |
|
| Placebo | Placebo Comparator | once daily subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCMCB07 | Drug | Subcutaneous injection of TCMCB07 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of people with an Adverse Event Assessment | Adverse Event monitoring | 6 Months |
| Number of participants with abnormal vital signs | Assessment of vital signs | 6 Months |
| Number of people with abnormal laboratory test results | Analysis of clinical chemistry, hematology, and urinalysis | 6 Months |
| Number of people with abnormal Electrocardiograms | 12-lead ECGs will be used and an assessment of any clinically significant abnormality from baseline will be reported as an AE | 6 Months |
| Number of people with abnormal physical examinations | Physical and injection site examination | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Non-compartmental techniques will be employed to obtain estimates of cmax | 6 Months |
| Area under the plasma concentration versus time curve (AUC) | Non-compartmental techniques will be employed to obtain estimates of AUC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Bermudez, MD, CPI | Quotient Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences -- Miami, Inc. | Miami | Florida | 33126 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| Drug |
Matching subcutaneous placebo |
|
| 6 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |