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Completed

NCT Number: NCT01395914

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

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.

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Key information

Conditions

Cachexia Body Weight Body Weight Changes Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Thinness Thoracic Neoplasms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Prairiewood, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anamorelin HCl

Drug

Placebo

Drug

Primary outcomes

  1. 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 outcomes

  1. Change in Body Weight

    Time frame: Change in body weight from baseline of the original trial through Week 12 of this extension trial.

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Helsinn Therapeutics (U.S.), Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Jul 18, 2011
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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