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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01387282




Registration number
NCT01387282
Ethics application status
Date submitted
30/06/2011
Date registered
4/07/2011
Date last updated
27/10/2017

Titles & IDs
Public title
Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2)
Scientific 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
Secondary ID [1] 0 0
HT-ANAM-302
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
Treatment: Drugs - Anamorelin HCl
Treatment: Drugs - Placebo

Active Comparator: 100 mg QD - Investigational: Anamorelin HCl; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.

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


Treatment: Drugs: Anamorelin HCl
Anamorelin HCL 100 mg will be orally administered daily at least 1 hour prior to meal

Treatment: Drugs: Placebo
Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour prior to meal before the first meal of the day.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Change in Lean Body Mass from Baseline Over 12 Weeks
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks
Secondary outcome [1] 0 0
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).
Timepoint [1] 0 0
Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks
Secondary outcome [2] 0 0
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).
Timepoint [2] 0 0
Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks
Secondary outcome [3] 0 0
Change in Body Weight - Change in body weight (BW) from baseline overall (i.e., over 12 weeks) for the MITT Population.
Timepoint [3] 0 0
Change in Body Weight from Baseline Over 12 Weeks

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Prairiewood
Recruitment hospital [2] 0 0
- East Bentleigh
Recruitment hospital [3] 0 0
- Parkville
Recruitment hospital [4] 0 0
- Adelaide
Recruitment postcode(s) [1] 0 0
- Prairiewood
Recruitment postcode(s) [2] 0 0
- East Bentleigh
Recruitment postcode(s) [3] 0 0
- Parkville
Recruitment postcode(s) [4] 0 0
- Adelaide
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
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
Hungary
State/province [11] 0 0
Budapest
Country [12] 0 0
Hungary
State/province [12] 0 0
Nyiregyhaza
Country [13] 0 0
Hungary
State/province [13] 0 0
Szekesfehervar
Country [14] 0 0
Hungary
State/province [14] 0 0
Szikszo
Country [15] 0 0
Hungary
State/province [15] 0 0
Torokbalint
Country [16] 0 0
Israel
State/province [16] 0 0
Beer-Sheva
Country [17] 0 0
Israel
State/province [17] 0 0
Haifa
Country [18] 0 0
Israel
State/province [18] 0 0
Jerusalem
Country [19] 0 0
Israel
State/province [19] 0 0
Kfar Saba
Country [20] 0 0
Israel
State/province [20] 0 0
Petach Tikvah
Country [21] 0 0
Israel
State/province [21] 0 0
Tel Aviv
Country [22] 0 0
Israel
State/province [22] 0 0
Tel-Hashomer
Country [23] 0 0
Israel
State/province [23] 0 0
Zerifin
Country [24] 0 0
Poland
State/province [24] 0 0
Bydgoszcz
Country [25] 0 0
Poland
State/province [25] 0 0
Grudziadz
Country [26] 0 0
Poland
State/province [26] 0 0
Katowice
Country [27] 0 0
Poland
State/province [27] 0 0
Krakow
Country [28] 0 0
Poland
State/province [28] 0 0
Lodz
Country [29] 0 0
Poland
State/province [29] 0 0
Lublin
Country [30] 0 0
Poland
State/province [30] 0 0
Szczecin
Country [31] 0 0
Poland
State/province [31] 0 0
Warszawa
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Ekaterinburg
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Krasnodar
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Moscow
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Novosibirsk
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Saint Petersburg
Country [37] 0 0
Russian Federation
State/province [37] 0 0
St. Petersburg
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Leicester
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Middlesex

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 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.
Trial website
https://clinicaltrials.gov/show/NCT01387282
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

Summary results
Other publications