Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)
This study has been completed.
Information provided by (Responsible Party):
Helsinn Therapeutics (U.S.), Inc
First received: June 30, 2011
Last updated: August 17, 2015
Last verified: August 2015
The administration of Anamorelin HCl in patients with Non-Small Cell Lung Cancer-Cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.
Non-Small Cell Lung Cancer
Drug: Anamorelin HCl
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study
Primary Outcome Measures:
- Evaluate the safety and tolerability of Anamorelin [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Incidence of adverse events (assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 [NCI CTCAE Version 4]) and Vital signs, electrocardiogram (ECG), and safety laboratory assessments will be assessed.
Secondary Outcome Measures:
- Evaluate the effect of Anamorelin on body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Changes in body weight from baseline of the HT-ANAM-301 or HT-ANAM-302 trials to Weeks 4, 8, and 12.
- Evaluate the effect of Anamorelin on muscle strength as measured by hand-grip strength (HGS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in HGS of the non-dominant hand and percent change from baseline of the original trials to Weeks 8 and 12.
- Evaluate the effect of Anamorelin HCl on quality of life as assessed using the FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) and the FAACT (Functional Assessment of Anorexia/Cachexia Treatment) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Quality of life as assessed by FACIT-F and FAACT at baseline of the original trials compared to Weeks 4, 8, and 12.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2014 (Final data collection date for primary outcome measure)
Experimental: 100 mg QD
100 mg yellow coated, oval tablet; oral administration once daily
Drug: Anamorelin HCl
Placebo Comparator: Placebo
Placebo tablets identical in appearance to active tablets; oral administration once daily
This is a randomized, double-blind, parallel-group, placebo-controlled, extension study to assess the safety and efficacy of Anamorelin HCl in NSCLC-C patients.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Has completed the Day 85 Visit in the original trial (Study HT-ANAM-301 or HT-ANAM-302) and is considered appropriate to continue to receive additional study drug; must start dosing on the extension study within 5 days of completing dosing on the original trial
- ECOG performance status ≤2
- Life expectancy of >4 months at time of screening
- If woman of childbearing potential or a fertile man, he/she must agree to use an effective form of contraception during the study and for 30 days following the last dose of study drug (an effective form of contraception is abstinence, a hormonal contraceptive, or a double-barrier method)
- Must be willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures
- Women who are pregnant or breast-feeding
- Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to enrollment into the extension study; patients must be well recovered from acute effects of surgery prior to screening; patients should not have plans to undergo major surgical procedures during the treatment period
- Currently taking prescription medications intended to increase appetite or treat weight loss; these include, but are not limited to, testosterone, androgenic compounds, megestrol acetate, methylphenidate, and dronabinol
- Inability to readily swallow oral tablets; patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded
- Has an active, uncontrolled infection
- Has known or symptomatic brain metastases
- Receiving strong CYP3A4 inhibitors
- Receiving tube feedings or parenteral nutrition (either total or partial); patients must have discontinued these treatments for at least 6 weeks prior to Day 1, and throughout the study duration
- Other clinical diagnosis, ongoing or intercurrent illness that in the Investigator's opinion would prevent the patient's participation
- Patients actively receiving a concurrent investigational agent, other than Anamorelin HCl
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01395914
Helsinn Therapeutics (U.S.), Inc
No publications provided
||Helsinn Therapeutics (U.S.), Inc
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 30, 2011
||August 17, 2015
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 13, 2015
Carcinoma, Non-Small-Cell Lung
Body Weight Changes
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Signs and Symptoms