Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)
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| ClinicalTrials.gov Identifier: NCT01387269 |
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Recruitment Status :
Completed
First Posted : July 4, 2011
Results First Posted : July 11, 2017
Last Update Posted : October 27, 2017
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Sponsor:
Helsinn Therapeutics (U.S.), Inc
Information provided by (Responsible Party):
Helsinn Therapeutics (U.S.), Inc
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Brief Summary:
The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cachexia Non-Small Cell Lung Cancer | Drug: Anamorelin HCl Drug: Placebo | Phase 3 |
This is a randomized, double-blind, placebo-controlled, multicenter study to assess the safety and efficacy of Anamorelin in patients with non-small cell lung cancer-cachexia (NSCLC-C). The primary efficacy analysis will include the treatment difference in the change in lean body mass and physical function. Pharmacokinetic (PK) samples will also be collected at Day 43 visit for population PK.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 484 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C |
| Study Start Date : | July 2011 |
| Actual Primary Completion Date : | January 2014 |
| Actual Study Completion Date : | February 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: 100 mg QD
Anamorelin HCL 100 mg will be administered daily
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Drug: Anamorelin HCl
Anamorelin HCl will be orally administered daily at least one hour before meal |
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Placebo Comparator: Placebo
Placebo tablets identical in appearance to active tablets; oral administration once daily
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Drug: Placebo
Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before meal |
Primary Outcome Measures :
- Change in Lean Body Mass [ Time Frame: Change in Lean Body Mass from Baseline Over 12 Weeks ]Change in Lean Body Mass (LBM) from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.
- Change in Handgrip Strength [ Time Frame: Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks ]Change in Handgrip Strength (HGS) of the non-dominant hand from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.
Secondary Outcome Measures :
- Change in A/CS Domain Score [ Time Frame: Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks ]
The Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Additional Concerns Subscale (A/CS domain) is a 12-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).
The 12-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the A/CS domain ranges from 0 (worst) to 48 (best).
- Change in FACIT-F Fatigue Domain Score [ Time Frame: Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks ]
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue domain is a 13-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).
The 13-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the FACIT-F fatigue domain ranges from 0 (worst) to 52 (best).
- Change in Body Weight [ Time Frame: Change in Body Weight from Baseline Over 12 Weeks ]Change in body weight (BW) from baseline overall (i.e., over 12 weeks) for the MITT Population.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Documented diagnosis of unresectable Stage III or Stage IV NSCLC
- Patients may be receiving maintenance chemotherapy
- Patients planning to initiate a new chemotherapy and/or radiation therapy regimen may do so only within ± 14 days of randomization
- Patients may have completed a chemotherapy and/or radiation therapy and/or have no plan to initiate a new regimen within 12 weeks from randomization; at least 14 days must elapse from the completion of the chemotherapy and/or radiation therapy prior to randomization
- Involuntary weight loss of ≥5% body weight within 6 months prior to screening or a screening body mass index (BMI) <20 kg/m2
- Body mass index ≤30 kg/m2
- Life expectancy of >4 months at time of screening
- ECOG performance status ≤2
- Adequate hepatic function, defined as AST and ALT levels ≤5 x upper limit of normal
- Adequate renal function, defined as creatinine ≤2 x upper limit of normal, or calculated creatinine clearance >30 ml/minute
- Ability to understand and comply with the procedures for the HGS evaluation
- If 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 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
Exclusion Criteria:
- Other forms of lung cancer (e.g., small cell, mesothelioma)
- Women who are pregnant or breast-feeding
- Known HIV, hepatitis (B&C), or active tuberculosis
- Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization; 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 uncontrolled diabetes mellitus
- Has untreated clinically relevant hypothyroidism
- Has known or symptomatic brain metastases
- Receiving strong CYP3A4 inhibitors within 14 days of randomization
- 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
- Has had previous exposure to Anamorelin HCl
- Patients actively receiving a concurrent investigational agent
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387269
Locations
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Sponsors and Collaborators
Helsinn Therapeutics (U.S.), Inc
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Helsinn Therapeutics (U.S.), Inc |
| ClinicalTrials.gov Identifier: | NCT01387269 |
| Other Study ID Numbers: |
HT-ANAM-301 |
| First Posted: | July 4, 2011 Key Record Dates |
| Results First Posted: | July 11, 2017 |
| Last Update Posted: | October 27, 2017 |
| Last Verified: | September 2017 |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Wasting Syndrome Cachexia Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Weight Loss Body Weight Changes Body Weight Thinness Metabolic Diseases Nutrition Disorders |