Expired Study
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Louisville, Kentucky


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

HT-ANAM-301


NCT ID:

NCT01387269


Secondary ID:


Study Acronym:


Brief Title:

Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Helsinn Therapeutics (U.S.), Inc


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

484


Enrollment Type:

Actual


Study Dates

Start Date:July 2011
Completion Date:February 2015
Completion Type:Actual
Primary Completion Date:January 2014
Primary Completion Type:Actual
Verification Date:September 2017
Last Changed Date:September 26, 2017
First Received Date:June 30, 2011
First Results Date:March 15, 2017

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in Body Weight
Time Frame:Change in Body Weight from Baseline Over 12 Weeks
Safety Issues:False
Description:Change in body weight (BW) from baseline overall (i.e., over 12 weeks) for the MITT Population.
Outcome Type:Secondary Outcome
Measure:Change in FACIT-F Fatigue Domain Score
Time Frame:Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks
Safety Issues:False
Description: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 rangi
Outcome Type:Secondary Outcome
Measure:Change in A/CS Domain Score
Time Frame:Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks
Safety Issues:False
Description: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-po
Outcome Type:Primary Outcome
Measure:Change in Handgrip Strength
Time Frame:Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Change in Lean Body Mass
Time Frame:Change in Lean Body Mass from Baseline Over 12 Weeks
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Drug
Name:Anamorelin HCl
Description:Anamorelin HCl will be orally administered daily at least one hour before meal
Arm Name:100 mg QD
Intervention Type:Drug
Name:Placebo
Description:Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before meal
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Placebo tablets identical in appearance to active tablets; oral administration once daily
Study Arm Type:Experimental
Arm Name:100 mg QD
Description:Anamorelin HCL 100 mg will be administered daily

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Helsinn Therapeutics (U.S.), Inc

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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