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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01395914
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : July 11, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Helsinn Therapeutics (U.S.), Inc

Tracking Information
First Submitted Date  ICMJE June 30, 2011
First Posted Date  ICMJE July 18, 2011
Results First Submitted Date  ICMJE March 15, 2017
Results First Posted Date  ICMJE July 11, 2017
Last Update Posted Date September 14, 2017
Study Start Date  ICMJE July 2011
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 15, 2011)
Evaluate the safety and tolerability of Anamorelin [ Time Frame: 12 weeks ]
Incidence of adverse events (assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 [NCI CTCAE Version 4]) and Vital signs, electrocardiogram (ECG), and safety laboratory assessments will be assessed.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2017)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2011)
  • Evaluate the effect of Anamorelin on body weight [ Time Frame: 12 weeks ]
    Changes in body weight from baseline of the HT-ANAM-301 or HT-ANAM-302 trials to Weeks 4, 8, and 12.
  • Evaluate the effect of Anamorelin on muscle strength as measured by hand-grip strength (HGS) [ Time Frame: 12 weeks ]
    Change in HGS of the non-dominant hand and percent change from baseline of the original trials to Weeks 8 and 12.
  • Evaluate the effect of Anamorelin HCl on quality of life as assessed using the FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) and the FAACT (Functional Assessment of Anorexia/Cachexia Treatment) [ Time Frame: 12 weeks ]
    Quality of life as assessed by FACIT-F and FAACT at baseline of the original trials compared to Weeks 4, 8, and 12.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)
Official Title  ICMJE Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cachexia
  • Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Anamorelin HCl
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: 100 mg QD
    100 mg yellow coated, oval tablet; oral administration once daily
    Intervention: Drug: Anamorelin HCl
  • Placebo Comparator: Placebo
    Placebo tablets identical in appearance to active tablets; oral administration once daily
    Intervention: Drug: Placebo
Publications * Currow D, Temel JS, Abernethy A, Milanowski J, Friend J, Fearon KC. ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia. Ann Oncol. 2017 Aug 1;28(8):1949-1956. doi: 10.1093/annonc/mdx192.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2017)
513
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belarus,   Belgium,   Canada,   Czechia,   France,   Germany,   Hungary,   Israel,   Italy,   Poland,   Russian Federation,   Serbia,   Slovenia,   Spain,   Ukraine,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01395914
Other Study ID Numbers  ICMJE HT-ANAM-303
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Helsinn Therapeutics (U.S.), Inc
Study Sponsor  ICMJE Helsinn Therapeutics (U.S.), Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Helsinn Therapeutics (U.S.), Inc
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP