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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier:
NCT01387269
First received: June 30, 2011
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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.


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): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Evaluate the effect of Anamorelin on lean body mass as measured by DXA scan [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Evaluate the effect of Anamorelin on muscle strength as measured by hand-grip strength [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the effect of Anamorelin HCl on body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To evaluate the effect of Anamorelin HCl on quality of life as assessed by 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 ]
  • To evaluate the effect of Anamorelin HCl on overall survival [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 477
Study Start Date: July 2011
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 100 mg QD Drug: Anamorelin HCl
Randomization of 2:1
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, placebo-controlled, multicenter study to assess the safety and efficacy of Anamorelin in patients with non-small cell lung cancer-cachexia (NSCLC-C). The primary efficacy analysis will include the treatment difference in the change in lean body mass and physical function. Pharmacokinetic (PK) samples will also be collected at Day 43 visit for population PK.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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

Exclusion 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
  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: NCT01387269

  Show 60 Study Locations
Sponsors and Collaborators
Helsinn Therapeutics (U.S.), Inc
  More Information

No publications provided

Responsible Party: Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier: NCT01387269     History of Changes
Other Study ID Numbers: HT-ANAM-301
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