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CachexiaPhase 3NCT01387269

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

A Phase 3 study testing Anamorelin HCl in people with Cachexia and Non-Small Cell Lung Cancer, run by Helsinn Therapeutics (U.S.), Inc at 60 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cachexia, Non-Small Cell Lung Cancer
What is being tested?
Anamorelin HCl
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
484 participants
Where
60 sitesin 16 countries
Study dates
Jul 2011to Feb 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

60 sites in 16 countries.

60 sites in 16 countries

United States12 sites

  • Study site

    Boston, Massachusetts

  • Study site

    Cincinnati, Ohio

  • Study site

    Fullerton, California

  • Study site

    Glendale, California

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    La Jolla, California

  • Study site

    Louisville, Kentucky

  • Study site

    Northport, New York

  • Study site

    Orange City, Florida

  • Study site

    Quincy, Illinois

  • Study site

    Riverside, California

Other trials in United States

Czechia5 sites

  • Study site

    Benešov

  • Study site

    Brno

  • Study site

    Hlučín

  • Study site

    Liberec

  • Study site

    Nymburk

Other trials in Czechia

Ukraine5 sites

  • Study site

    Dnipropetrovsk

  • Study site

    Donetsk

  • Study site

    Kharkiv

  • Study site

    Kyiv

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Belgium4 sites

  • Study site

    Antwerp

  • Study site

    Brussels

  • Study site

    Genk

  • Study site

    Liège

Other trials in Belgium

Canada4 sites

  • Study site

    Edmonton, Alberta

  • Study site

    Montreal, Quebec

  • Study site

    Sault Ste. Marie, Ontario

  • Study site

    Toronto, Ontario

Other trials in Canada

Germany4 sites

  • Study site

    Berlin

  • Study site

    Großhansdorf

  • Study site

    Halle

  • Study site

    Minden

Other trials in Germany

Netherlands4 sites

  • Study site

    Amsterdam

  • Study site

    Goes

  • Study site

    Maastricht

  • Study site

    Nieuwegein

Other trials in Netherlands

Poland4 sites

  • Study site

    Grudziądz

  • Study site

    Katowice

  • Study site

    Krakow

  • Study site

    Lublin

Other trials in Poland

Spain4 sites

  • Study site

    Barcelona

  • Study site

    Córdoba

  • Study site

    Seville

  • Study site

    Valencia

Other trials in Spain

Belarus3 sites

  • Study site

    Brest

  • Study site

    Lesnoy

  • Study site

    Minsk

Other trials in Belarus

France2 sites

  • Study site

    Lyon

  • Study site

    Villejuif

Other trials in France

Italy2 sites

  • Study site

    Placenza

  • Study site

    Rozzano

Other trials in Italy

Russia2 sites

  • Study site

    Saint Petersburg

  • Study site

    Yekaterinburg

Other trials in Russia

Serbia2 sites

  • Study site

    Belgrade

  • Study site

    Kamenitz

Other trials in Serbia

Slovenia2 sites

  • Study site

    Golnik

  • Study site

    Ljubljana

Other trials in Slovenia

Hungary1 site

  • Study site

    Budapest

Other trials in Hungary

About this study

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

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.

Read the 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.

Being tested
Anamorelin HCl, Placebo
Medical subject headings
Cachexia, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anamorelin HClDrug

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

  • PlaceboDrug

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

Study groups in NCT01387269
Study groupRoleWhat they receive
100 mg QDExperimentalAnamorelin HCL 100 mg will be administered daily
Receives: Drug: Anamorelin HCl
PlaceboPlacebo comparatorPlacebo tablets identical in appearance to active tablets; oral administration once daily
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change in Lean Body Mass from Baseline Over 12 Weeks

  2. 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.

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

Secondary outcomes (3)

  1. Change in A/CS Domain Score

    The Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Additional Concerns Subscale (A/CS domain) is a 12-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. 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).

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

  2. Change in FACIT-F Fatigue Domain Score

    The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue domain is a 13-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).

    The 13-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 FACIT-F fatigue domain ranges from 0 (worst) to 52 (best).

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

  3. Change in Body Weight

    Change in body weight (BW) from baseline overall (i.e., over 12 weeks) for the MITT Population.

    Measured: Change in Body Weight from Baseline Over 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionJan 2014
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
484 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01387269
Sponsor's protocol ID
HT-ANAM-301
Status last verified
Sep 2017
First submitted
30 Jun 2011
Last updated
27 Oct 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 39992021

  • 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.

    PubMed 28472437

  • 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.

    PubMed 26906526

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Anamorelin HCl in people with Cachexia and Non-Small Cell Lung Cancer, run by Helsinn Therapeutics (U.S.), Inc at 60 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Czechia, Ukraine, Belgium, Canada and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Lean Body Mass (time frame: Change in Lean Body Mass from Baseline Over 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01387269, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.

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