Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)

August 16, 2017 updated by: Helsinn Therapeutics (U.S.), Inc

Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

513

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
      • East Bentleigh, Australia
      • Victoria, Australia
    • New South Wales
      • Prairiewood, New South Wales, Australia
  • Belarus
      • Brest, Belarus
      • Lesnoy, Belarus
      • Minsk, Belarus
  • Belgium
      • Antwerpen, Belgium
      • Brussels, Belgium
      • Genk, Belgium
      • Gent, Belgium
      • Liege, Belgium
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • Ontario
      • Sault Ste Marie, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Czechia
      • Benesov, Czechia
      • Brno, Czechia
      • Hlucin, Czechia
      • Liberec, Czechia
      • Nymburk, Czechia
  • France
      • Lyon Cedex, France
      • Villejuif cedex, France
  • Germany
      • Grosshansdorf, Germany
      • Halle, Germany
  • Hungary
      • Budapest, Hungary
      • Kassai, Hungary
  • Israel
      • Beer-Sheva, Israel
      • Petach Tikvah, Israel
      • Tel-Hashomer, Israel
      • Zerifin, Israel
  • Italy
      • Piacenza, Italy
  • Poland
      • Bydgoszcz, Poland
      • Grudziadz, Poland
      • Katowice, Poland
      • Krakow, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Szczecin, Poland
      • Warszawa, Poland
  • Russian Federation
      • Ekaterinburg, Russian Federation
      • Krasnodar, Russian Federation
      • Moscow, Russian Federation
      • St. Petersburg, Russian Federation
  • Serbia
      • Belgrade, Serbia
      • Sremska Kamenica, Serbia
  • Slovenia
      • Ljubljana, Slovenia
  • Spain
      • Barcelona, Spain
      • Sevilla, Spain
      • Valencia, Spain
  • Ukraine
      • Dnipropetrovsk, Ukraine
      • Kharkiv, Ukraine
      • Kyiv, Ukraine
  • United States
    • California
      • Corona, California, United States
      • Fountain Valley, California, United States
      • Fullerton, California, United States
      • Glendale, California, United States
      • La Jolla, California, United States
      • Riverside, California, United States
    • District of Columbia
      • Washington, D.C., District of Columbia, United States
    • Florida
      • Orange City, Florida, United States
    • Illinois
      • Quincy, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • New York
      • Lake Success, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Sylvania, Ohio, United States
    • Pennsylvania
      • West Reading, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • Virginia
      • Falls Church, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo tablets identical in appearance to active tablets; oral administration once daily
Drug: Placebo
Experimental: 100 mg QD
100 mg yellow coated, oval tablet; oral administration once daily
Drug: Anamorelin HCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Treatment-emergent Adverse Events
Time Frame: Over the 12-week treatment period
To Evaluate the Safety and Tolerability of Anamorelin HCl.
Over the 12-week treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight
Time Frame: Change in body weight from baseline of the original trial through Week 12 of this extension trial.
Change in body weight from baseline of the original trial through Week 12 of this extension trial.
Change in Handgrip Strength of the Non-Dominant Hand
Time Frame: Change in HGS from baseline of the original trial through Week 12 of this extension trial.
Change in HGS from baseline of the original trial through Week 12 of this extension trial.
Change in A/CS Domain Score
Time Frame: Change in FAACT A/CS Domain Score from baseline of the original trial through Week 12 of this extension trial

Change in the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) 12-item Additional Concerns Subscale (A/CS) domain score is a 12-item scale. 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 FAACT A/CS Domain Score from baseline of the original trial through Week 12 of this extension trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinn Therapeutics (U.S.), Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

June 30, 2011

First Submitted That Met QC Criteria

July 15, 2011

First Posted (Estimate)

July 18, 2011

Study Record Updates

Last Update Posted (Actual)

September 14, 2017

Last Update Submitted That Met QC Criteria

August 16, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HT-ANAM-303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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