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

NCT01387269 | Completed Phase 3 Results DMC

• 1 other identifier: HT-ANAM-301
• Study Type: interventional
• Target: 484
• Locations: 15 countries
• Sites: 56

Brief 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.

Conditions

Cachexia; Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Change in Lean Body Mass

  Change in Lean Body Mass (LBM) from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.

  Change in Lean Body Mass from Baseline Over 12 Weeks

• Change in Handgrip Strength

  Change in Handgrip Strength (HGS) of the non-dominant hand from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.

  Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks

Secondary Outcomes (3)

• Change in A/CS Domain Score

  Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks

• Change in FACIT-F Fatigue Domain Score

  Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks

• Change in Body Weight

  Change in Body Weight from Baseline Over 12 Weeks

Study Arms (2)

100 mg QD

EXPERIMENTAL

Anamorelin HCL 100 mg will be administered daily

Drug: Anamorelin HCl

Placebo

PLACEBO COMPARATOR

Placebo tablets identical in appearance to active tablets; oral administration once daily

Drug: Placebo

Interventions

Anamorelin HCl DRUG

Anamorelin HCl will be orally administered daily at least one hour before meal

100 mg QD

Placebo DRUG

Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before meal

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinn Therapeutics (U.S.), Inc: lead

Study Sites (60)

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Fullerton, California, United States

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Glendale, California, United States

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La Jolla, California, United States

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Riverside, California, United States

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Orange City, Florida, United States

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Quincy, Illinois, United States

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Indianapolis, Indiana, United States

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Louisville, Kentucky, United States

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Boston, Massachusetts, United States

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Northport, New York, United States

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Cincinnati, Ohio, United States

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Houston, Texas, United States

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Brest, Belarus

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Lesnoy, Belarus

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Minsk, Belarus

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Antwerp, Belgium

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Brussels, Belgium

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Genk, Belgium

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Liège, Belgium

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Edmonton, Alberta, Canada

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Sault Ste. Marie, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Benešov, Czechia

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Brno, Czechia

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Hlučín, Czechia

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Liberec, Czechia

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Nymburk, Czechia

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Lyon, France

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Villejuif, France

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Berlin, Germany

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Großhansdorf, Germany

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Halle, Germany

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Minden, Germany

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Budapest, Hungary

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Placenza, Italy

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Rozzano, Italy

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Amsterdam, Netherlands

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Goes, Netherlands

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Maastricht, Netherlands

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Nieuwegein, Netherlands

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Grudziądz, Poland

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Katowice, Poland

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Krakow, Poland

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Lublin, Poland

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Saint Petersburg, Russia

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Yekaterinburg, Russia

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Belgrade, Serbia

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Kamenitz, Serbia

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Golnik, Slovenia

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Ljubljana, Slovenia

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Barcelona, Spain

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Córdoba, Spain

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Seville, Spain

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Valencia, Spain

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Dnipropetrovsk, Ukraine

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Donetsk, Ukraine

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Kharkiv, Ukraine

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Kyiv, Ukraine

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Zaporizhzhya, Ukraine

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Related Publications (3)

• Laird BJA, Skipworth R, Bonomi PD, Fallon M, Kaasa S, Giorgino R, McMillan DC, Currow DC. Anamorelin Efficacy in Non-Small-Cell Lung Cancer Patients With Cachexia: Insights From ROMANA 1 and ROMANA 2. J Cachexia Sarcopenia Muscle. 2025 Feb;16(1):e13732. doi: 10.1002/jcsm.13732.

  PMID: 39992021 DERIVED

• 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.

  PMID: 28472437 DERIVED

• Temel JS, Abernethy AP, Currow DC, Friend J, Duus EM, Yan Y, Fearon KC. Anamorelin in patients with non-small-cell lung cancer and cachexia (ROMANA 1 and ROMANA 2): results from two randomised, double-blind, phase 3 trials. Lancet Oncol. 2016 Apr;17(4):519-531. doi: 10.1016/S1470-2045(15)00558-6. Epub 2016 Feb 20.

  PMID: 26906526 DERIVED

MeSH Terms

Conditions

Cachexia; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Richard K. Bourne, Ph.D.
• Organization: Helsinn Therapeutics (US), Inc.

richard.bourne@helsinn.com

732-603-2852

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 4, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2015
• Last Updated: October 27, 2017
• Results First Posted: July 11, 2017

Record last verified: 2017-09

Locations

DE (4); ES (4); SE (2); US (12); CZ (5); BE (3); PL (4); RU (2); FR (2); NL (4); CA (4); SL (2); UA (5); HU (1); IT (2)