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CompletedPhase 3NCT01387269
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAnamorelin HCl and Placebo

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 27, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?60 U.S. locations

Locations may change over time.

Who runs it?Helsinn Therapeutics (U.S.), Inc

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Helsinn Therapeutics (U.S.), Inc
Interventions being studied
Drug: Anamorelin HCl; Drug: Placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Locally advanced→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Study locationFullerton, California
  • Study locationGlendale, California
  • Study locationLa Jolla, California
  • Study locationRiverside, California
  • Study locationOrange City, Florida
  • Study locationQuincy, Illinois
  • Study locationIndianapolis, Indiana
  • Study locationLouisville, Kentucky
  • Study locationBoston, Massachusetts
  • Study locationNorthport, New York
  • Study locationCincinnati, Ohio
  • Study locationHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 27, 2017. Always confirm current availability with the study team.

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