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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01395914




Registration number
NCT01395914
Ethics application status
Date submitted
30/06/2011
Date registered
18/07/2011
Date last updated
14/09/2017

Titles & IDs
Public title
Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)
Scientific title
Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study
Secondary ID [1] 0 0
HT-ANAM-303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cachexia 0 0
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: 100 mg QD - 100 mg yellow coated, oval tablet; oral administration once daily

Placebo comparator: Placebo - Placebo tablets identical in appearance to active tablets; oral administration once daily
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Treatment-emergent Adverse Events
Timepoint [1] 0 0
Over the 12-week treatment period
Secondary outcome [1] 0 0
Change in Body Weight
Timepoint [1] 0 0
Change in body weight from baseline of the original trial through Week 12 of this extension trial.
Secondary outcome [2] 0 0
Change in Handgrip Strength of the Non-Dominant Hand
Timepoint [2] 0 0
Change in HGS from baseline of the original trial through Week 12 of this extension trial.
Secondary outcome [3] 0 0
Change in A/CS Domain Score
Timepoint [3] 0 0
Change in FAACT A/CS Domain Score from baseline of the original trial through Week 12 of this extension trial

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2015
Sample size
Target
Accrual to date
Final
513
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- Prairiewood
Recruitment hospital [2] 0 0
- Adelaide
Recruitment hospital [3] 0 0
- East Bentleigh
Recruitment hospital [4] 0 0
- Victoria
Recruitment postcode(s) [1] 0 0
- Prairiewood
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- East Bentleigh
Recruitment postcode(s) [4] 0 0
- Victoria
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Massachusetts
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New York
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United States of America
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North Carolina
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Ohio
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Virginia
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Belarus
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Brest
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Belarus
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Lesnoy
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Belarus
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Minsk
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Belgium
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Antwerpen
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Belgium
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Brussels
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Belgium
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Genk
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Belgium
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Gent
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Belgium
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Liege
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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Czechia
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Benesov
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Czechia
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Brno
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Czechia
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Hlucin
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Czechia
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Liberec
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Czechia
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Nymburk
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France
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Lyon Cedex
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France
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Villejuif cedex
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Germany
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Grosshansdorf
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Germany
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Halle
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Hungary
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Budapest
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Hungary
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Kassai
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Israel
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Beer-Sheva
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Israel
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Petach Tikvah
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Israel
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Tel-Hashomer
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Israel
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Zerifin
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Italy
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Piacenza
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Poland
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Bydgoszcz
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Poland
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Grudziadz
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Poland
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Katowice
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Szczecin
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Poland
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Warszawa
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Russian Federation
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Ekaterinburg
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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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Serbia
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Belgrade
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Serbia
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Sremska Kamenica
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Slovenia
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Ljubljana
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Spain
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Barcelona
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Spain
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Sevilla
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Spain
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Valencia
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Ukraine
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Dnipropetrovsk
Country [60] 0 0
Ukraine
State/province [60] 0 0
Kharkiv
Country [61] 0 0
Ukraine
State/province [61] 0 0
Kyiv

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Helsinn Therapeutics (U.S.), Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT01395914
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01395914