The Role of Ghrelin in Cancer Cachexia

NCT01505764 | Terminated Phase 2 Results

• 2 other identifiers: CLIN-013-08FHT-ANAM-208
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer is often coupled with a condition called cachexia. In this condition, individuals continue to lose weight and lean body mass, which means their muscles are getting smaller and weaker. Studies have shown that cancer patients who are losing weight often are responding poorly to chemotherapy, are at greater risk of infection and have a reduced life expectancy. Also, people may not want to eat. To date, there are no approved treatments available for this condition. This study is going to study the benefits of the use of the study drug, Anamorelin hydrochloride (HCl) in treatment or prevention of cachexia associated with cancer. Studies done before with the study drug have shown that the drug can help the cachectic condition. The purpose of this research study is to evaluate the effectiveness of Anamorelin HCl compared to placebo on body composition (amount of cell mass, fat, muscle, etc.) including measurements of body potassium and nitrogen stores. In addition to the above, the study will also assess the effect of the study drug on handgrip strength, body weight, lean muscle mass, quality of life, appetite \& food intake, certain blood markers, energy expenditure (the amount of energy participants burn), functional performance, safety and tolerability of Anamorelin HCl.

Conditions

Cancer Cachexia

Keywords

Cachexia

Outcome Measures

Primary Outcomes (1)

• Total Body Potassium.

  percentage change from baseline

  day 84

Secondary Outcomes (11)

• Lean Mass Measured by Densitometry.

  day 84

• Muscle Strength as Measured by Grip Strength.

  day 84

• Body Weight.

  day 84

• Quality of Life.

  day 84

• Appetite.

  day 84

Study Arms (2)

Arm 1 (Anamorelin HCl)

EXPERIMENTAL

Anamorelin HCl

Drug: Anamorelin HCl

Arm 2 (Placebo)

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Anamorelin HCl DRUG

100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.

Arm 1 (Anamorelin HCl)

Placebo DRUG

Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.

Arm 2 (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have incurable, histologically or cytologically documented Non-Small Cell Lung Cancer or Colo-rectal Cancer.
• Females and males at least 18 years of age.
• Documented histologic or cytologic diagnosis of American Joint Committee on Cancer (AJCC) unresectable Stage III or IV NSCLC and/or stage III or IV colorectal cancer (CRC) (not amenable to curative resection).
• Involuntary weight loss of 5% body weight over a period of 6 months.
• Eastern Cooperative Oncology Group (ECOG) performance status 2 at screening.
• Estimated life expectancy of greater than 4 months at the time of screening.
• Presence and functional use of both hands.
• Able to understand and comply with the procedures of the handgrip strength evaluation.
• If the patient is a woman of childbearing potential or a fertile man, he/she must agree to use an effective form of contraception during the study and for 28 days following the last dose of study medication.
• Willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures.

You may not qualify if:

• Other forms of lung cancer.
• Women who are pregnant or breast-feeding.
• Obesity.
• Recent active excessive alcohol or illicit drug use current use of marijuana or history of marijuana use over the previous 6 months.
• Severe depression.
• Other causes of cachexia such as:
• Liver disease (AST or ALT \> 3x normal levels)
• Renal failure (creatinine \> 2.5 mg/dL)
• Untreated thyroid disease
• Class III-IV CHF
• AIDS
• Other cancer diagnosed within the past five years other than non-melanoma skin cancer and prostate cancer
• Severe COPD requiring use of home O2.
• Inability to increase food intake.
• Recent administration of highly emetogenic chemotherapy.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Helsinn Therapeutics (U.S.), Inc: collaborator

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cachexia

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Results Point of Contact

• Title: Jose M Garcia MD, PhD, Clinician Investigator
• Organization: Department of Veterans Affairs

jose.garcia@va.gov

206-7642984

Study Officials

• Jose M. Garcia, MD PhD

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: January 9, 2012
• Study Start: June 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 17, 2018
• Results First Posted: February 24, 2017

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)