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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier:
NCT01395914
First received: June 30, 2011
Last updated: August 16, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention Phase
Cachexia Non-Small Cell Lung Cancer Drug: Anamorelin HCl Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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): An Extension Study

Resource links provided by NLM:


Further study details as provided by Helsinn Therapeutics (U.S.), Inc:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 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 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).



Enrollment: 513
Study Start Date: July 2011
Study Completion Date: February 2015
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Placebo

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395914

  Hide Study Locations
Locations
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
United States, District of Columbia
Washington, D.C., District of Columbia, United States
United States, Florida
Orange City, Florida, United States
United States, Illinois
Quincy, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, New York
Lake Success, New York, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Ohio
Cleveland, Ohio, United States
Sylvania, Ohio, United States
United States, Pennsylvania
West Reading, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Virginia
Falls Church, Virginia, United States
Australia, New South Wales
Prairiewood, New South Wales, Australia
Australia
Adelaide, Australia
East Bentleigh, Australia
Victoria, Australia
Belarus
Brest, Belarus
Lesnoy, Belarus
Minsk, Belarus
Belgium
Antwerpen, Belgium
Brussels, Belgium
Genk, Belgium
Gent, Belgium
Liege, Belgium
Canada, Alberta
Edmonton, Alberta, Canada
Canada, Ontario
Sault Ste Marie, Ontario, Canada
Toronto, Ontario, Canada
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
Sponsors and Collaborators
Helsinn Therapeutics (U.S.), Inc
  More Information

Responsible Party: Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier: NCT01395914     History of Changes
Other Study ID Numbers: HT-ANAM-303
Study First Received: June 30, 2011
Results First Received: March 15, 2017
Last Updated: August 16, 2017

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Cachexia
Wasting Syndrome
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders

ClinicalTrials.gov processed this record on September 19, 2017