Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
Belarus
State/province [14] 0 0
Brest
Country [15] 0 0
Belarus
State/province [15] 0 0
Lesnoy
Country [16] 0 0
Belarus
State/province [16] 0 0
Minsk
Country [17] 0 0
Belgium
State/province [17] 0 0
Antwerpen
Country [18] 0 0
Belgium
State/province [18] 0 0
Brussels
Country [19] 0 0
Belgium
State/province [19] 0 0
Genk
Country [20] 0 0
Belgium
State/province [20] 0 0
Gent
Country [21] 0 0
Belgium
State/province [21] 0 0
Liege
Country [22] 0 0
Canada
State/province [22] 0 0
Alberta
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
Czechia
State/province [25] 0 0
Benesov
Country [26] 0 0
Czechia
State/province [26] 0 0
Brno
Country [27] 0 0
Czechia
State/province [27] 0 0
Hlucin
Country [28] 0 0
Czechia
State/province [28] 0 0
Liberec
Country [29] 0 0
Czechia
State/province [29] 0 0
Nymburk
Country [30] 0 0
France
State/province [30] 0 0
Lyon Cedex
Country [31] 0 0
France
State/province [31] 0 0
Villejuif cedex
Country [32] 0 0
Germany
State/province [32] 0 0
Grosshansdorf
Country [33] 0 0
Germany
State/province [33] 0 0
Halle
Country [34] 0 0
Hungary
State/province [34] 0 0
Budapest
Country [35] 0 0
Hungary
State/province [35] 0 0
Kassai
Country [36] 0 0
Israel
State/province [36] 0 0
Beer-Sheva
Country [37] 0 0
Israel
State/province [37] 0 0
Petach Tikvah
Country [38] 0 0
Israel
State/province [38] 0 0
Tel-Hashomer
Country [39] 0 0
Israel
State/province [39] 0 0
Zerifin
Country [40] 0 0
Italy
State/province [40] 0 0
Piacenza
Country [41] 0 0
Poland
State/province [41] 0 0
Bydgoszcz
Country [42] 0 0
Poland
State/province [42] 0 0
Grudziadz
Country [43] 0 0
Poland
State/province [43] 0 0
Katowice
Country [44] 0 0
Poland
State/province [44] 0 0
Krakow
Country [45] 0 0
Poland
State/province [45] 0 0
Lodz
Country [46] 0 0
Poland
State/province [46] 0 0
Lublin
Country [47] 0 0
Poland
State/province [47] 0 0
Szczecin
Country [48] 0 0
Poland
State/province [48] 0 0
Warszawa
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Ekaterinburg
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Krasnodar
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Moscow
Country [52] 0 0
Russian Federation
State/province [52] 0 0
St. Petersburg
Country [53] 0 0
Serbia
State/province [53] 0 0
Belgrade
Country [54] 0 0
Serbia
State/province [54] 0 0
Sremska Kamenica
Country [55] 0 0
Slovenia
State/province [55] 0 0
Ljubljana
Country [56] 0 0
Spain
State/province [56] 0 0
Barcelona
Country [57] 0 0
Spain
State/province [57] 0 0
Sevilla
Country [58] 0 0
Spain
State/province [58] 0 0
Valencia
Country [59] 0 0
Ukraine
State/province [59] 0 0
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01395914