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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier:
NCT01395914
First received: June 30, 2011
Last updated: July 31, 2014
Last verified: July 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • Evaluate the safety and tolerability of Anamorelin [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Evaluate the effect of Anamorelin on body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Quality of life as assessed by FACIT-F and FAACT at baseline of the original trials compared to Weeks 4, 8, and 12.


Estimated Enrollment: 300
Study Start Date: July 2011
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
Genders Eligible for Study:   Both
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

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Sponsors and Collaborators
Helsinn Therapeutics (U.S.), Inc
  More Information

No publications provided

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
Last Updated: July 31, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 21, 2014