CachexiaPhase 3NCT01395914
Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)
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 72 sites in 17 countries.
Trial 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. 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
- 513 participants
- Where
- 72 sitesin 17 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
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
72 sites in 17 countries.
72 sites in 17 countries
United States19 sites
Study site
Boston, Massachusetts
Study site
Charleston, South Carolina
Study site
Cleveland, Ohio
Study site
Corona, California
Study site
Durham, North Carolina
Study site
Falls Church, Virginia
Study site
Fountain Valley, California
Study site
Fullerton, California
Study site
Glendale, California
Study site
Indianapolis, Indiana
Study site
La Jolla, California
Study site
Lake Success, New York
Study site
Louisville, Kentucky
Study site
Orange City, Florida
Study site
Quincy, Illinois
Study site
Riverside, California
Study site
Sylvania, Ohio
Study site
Washington D.C., District of Columbia
Study site
West Reading, Pennsylvania
Poland8 sites
Study site
Bydgoszcz
Study site
Grudziądz
Study site
Katowice
Study site
Krakow
Study site
Lodz
Study site
Lublin
Study site
Szczecin
Study site
Warsaw
Belgium5 sites
Study site
Antwerp
Study site
Brussels
Study site
Genk
Study site
Ghent
Study site
Liège
Czechia5 sites
Study site
Benešov
Study site
Brno
Study site
Hlučín
Study site
Liberec
Study site
Nymburk
Australia4 sites
Study site
Adelaide
Study site
East Bentleigh
Study site
Prairiewood, New South Wales
Study site
Victoria
Canada4 sites
Study site
Edmonton, Alberta
Study site
Montreal, Quebec
Study site
Sault Ste. Marie, Ontario
Study site
Toronto, Ontario
Israel4 sites
Study site
Beersheba
Study site
Petach Tikvah
Study site
Tel HaShomer
Study site
Tsrifin
Russia4 sites
Study site
Krasnodar
Study site
Moscow
Study site
Saint Petersburg
Study site
Yekaterinburg
About this study
Official title: Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study
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.
Read the 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.
- Conditions
- Cachexia, Non-Small Cell Lung Cancer
- 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
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 100 mg QD | Experimental | 100 mg yellow coated, oval tablet; oral administration once daily Receives: Drug: Anamorelin HCl |
| Placebo | Placebo comparator | Placebo 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.
Percentage of Participants With Treatment-emergent Adverse Events
To Evaluate the Safety and Tolerability of Anamorelin HCl.
Measured: Over the 12-week treatment period
Secondary outcomes (3)
Change in Body Weight
Measured: 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
Measured: Change in HGS from baseline of the original trial through Week 12 of this extension trial.
Change in A/CS Domain Score
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).
Measured: Change in FAACT A/CS Domain Score from baseline of the original trial through Week 12 of this extension trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CachexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 513 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinn Therapeutics (U.S.), Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395914
- Sponsor's protocol ID
- HT-ANAM-303
- Status last verified
- Aug 2017
- First submitted
- 30 Jun 2011
- Last updated
- 14 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 28472437
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study
- ClinicalTrials.gov ID
- NCT01395914
- Acronym / sponsor ID
- HT-ANAM-303
- Conditions
- Cachexia, Non-Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- Helsinn Therapeutics (U.S.), IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 18 Jul 2011 (estimated)
- Results
- Posted 11 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100 mg QD | Experimental | Drug: Anamorelin HCl100 mg yellow coated, oval tablet; oral administration once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets identical in appearance to active tablets; oral administration once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anamorelin HCl | Drug | 100 mg QD |
| Placebo | Drug | Placebo |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28472437Currow 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
72 sites in 17 countries: see every site and its status.
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 72 sites in 17 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 5 inclusion and 10 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 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, Poland, Belgium, Czechia, Australia and 12 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?
Percentage of Participants With Treatment-emergent Adverse Events (time frame: Over the 12-week treatment period). 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 NCT01395914, which also lists 1 linked publication.
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 14 Sep 2017.