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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03743064




Registration number
NCT03743064
Ethics application status
Date submitted
14/11/2018
Date registered
15/11/2018
Date last updated
6/04/2023

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Scientific title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Secondary ID [1] 0 0
2018-002927-40
Secondary ID [2] 0 0
ANAM-17-21
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cachexia; Cancer 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
Mental Health 0 0 0 0
Eating disorders
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 Oral Tablet

Experimental: 100 mg anamorelin HCl - 100 mg anamorelin HCl (administered as 100 mg tablets in the fasted condition)

Placebo Comparator: Placebo - Placebo oral tablet (administered as matching placebo tablets in the fasted condition)


Treatment: Drugs: anamorelin HCl
100 mg anamorelin HCl (administered as 100 mg tablets in the fasted condition)

Treatment: Drugs: Placebo Oral Tablet
Placebo (administered as matching placebo tablets in the fasted condition)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
body weight
Timepoint [1] 0 0
From baseline until week 12
Primary outcome [2] 0 0
5 item Anorexia Symptom Subscale
Timepoint [2] 0 0
From baseline until week 12
Secondary outcome [1] 0 0
body weight
Timepoint [1] 0 0
From baseline until week 12
Secondary outcome [2] 0 0
body weight
Timepoint [2] 0 0
From baseline until week 12
Secondary outcome [3] 0 0
5 item Anorexia Symptom Subscale
Timepoint [3] 0 0
From baseline until week 12
Secondary outcome [4] 0 0
5 item Anorexia Symptom Subscale
Timepoint [4] 0 0
From baseline until week 12
Secondary outcome [5] 0 0
FAACT 12-item A/CS domain
Timepoint [5] 0 0
From baseline until week 12
Secondary outcome [6] 0 0
FACIT-F
Timepoint [6] 0 0
From baseline until week 12
Secondary outcome [7] 0 0
FAACT total score
Timepoint [7] 0 0
From baseline until week 12

Eligibility
Key inclusion criteria
1. Signed written informed consent

2. Female or male =18 years of age

3. Documented histologic or cytologic diagnosis of American Joint Committee on Cancer
(AJCC) Stage III or IV NSCLC. Stage III patient must have unresectable disease

4. Body mass index < 20 kg/m2 with involuntary weight loss of >2% within 6 months prior
to screening

5. Ongoing problems with appetite/eating associated with the underlying cancer, as
determined by having score of = 17 points on the 5-item Anorexia Symptom Scale and =
37 points on the 12-item FAACT A/CS

6. Patient receiving or not receiving systemic anti-cancer treatment at the time of
screening are eligible to participate. Systemic anti-cancer treatment includes first,
second, third treatment line with chemotherapy/radiation therapy, immunotherapy or
targeted therapy.

Patient not receiving systemic anti-cancer treatment is eligible if:

1. Not planning to receive anti-cancer treatment and/or at least 14 days must be
elapsed from the completion of prior treatment at the day of screening, in case
underwent previous cycle OR

2. Planning to receive anti-cancer treatment within 14 days from randomization
and/or at least 14 days must be elapsed from the completion of prior treatment at
the day of screening, in case underwent previous cycle OR

3. Patient on palliative care treatment

7. ECOG performance status 0,1 or 2 at screening

8. AST (SGOT) and ALT (SGPT) = 3 x ULN or if hepatic metastases are present = 5 x ULN

9. Adequate renal function, defined as creatinine =2 ULN, or calculated creatinine
clearance >30 ml/minute

10. Female patient shall be: a) of non-childbearing potential or b) of childbearing
potential using reliable contraceptive measures and having a negative urine pregnancy
test within 24 hours prior to first dose of investigational product.

Notes:

1. Female patient of non-childbearing potential are defined as being in
post-menopausal state since at least 1 year; or having documented surgical
sterilization or hysterectomy at least 3 months before study participation.

2. Reliable contraceptive measures include implants, injectables, combined oral
contraceptives, intrauterine devices, vasectomized partner or complete (long
term) sexual abstinence.

11. The patient must be willing and able to comply with the protocol tests and procedures
All inclusion criteria will be checked at screening visit (Visit 1).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient with other forms of lung cancer (e.g., small cell, neuroendocrine tumors)

2. Woman who is pregnant or breast-feeding

3. Reversible causes of reduced food intake, as determined by the Investigator. These
causes may include but are not limited to:

1. NCI CTCAE Grade 3 or 4 oral mucositis,

2. NCI CTCAE Grade 3 or 4 GI disorders [nausea, vomiting, diarrhea, and
constipation],

3. mechanical obstructions making patient unable to eat, or

4. severe depression

4. Patient undergoing major surgery (central venous access placement and tumor biopsies
are not considered major surgery) within 4 weeks prior to randomization. Patient must
be well recovered from acute effects of surgery prior to screening. Patient should not
have plans to undergo major surgical procedures during the treatment period

5. Patient currently taking androgenic compounds (including but not limited to
testosterone, testosterone-like agents, oxandrolone, megestrol acetate,
corticosteroids, olanzapine, mirtazapine (however, long-term use of mirtazapine for
depression for at least four weeks prior to screening is allowed), dronabinol or
marijuana (cannabis) or any other prescription medication or off-label products
intended to increase appetite or treat unintentional weight loss

6. Patient with pleural effusion requiring thoracentesis, pericardial effusion requiring
drainage, edema or evidence of ascites

7. Patient with uncontrolled or significant cardiovascular disease, including:

1. History of myocardial infarction within the past 3 months

2. A-V block of second or third degree (may be eligible if currently have a
pacemaker)

3. Unstable angina

4. Congestive heart failure within the past 3 months, if defined as NYHA class
III-IV

5. Any history of clinically significant ventricular arrhythmias (such as
ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW)
syndrome, or torsade de pointes)

6. Uncontrolled hypertension (blood pressure >150 mm Hg systolic and >95 mm Hg
diastolic)

7. Heart rate < 50 beats per minute on pre-entry electrocardiogram and patient is
symptomatic

8. Patient on drugs that may prolong the PR or QRS interval durations, such as any of the
antiarrhythmic medications Class I (Fast sodium (Na) channel blockers)

9. Patient unable to readily swallow oral tablets

10. Patient with severe gastrointestinal disease (including esophagitis, gastritis,
malabsorption)

11. Patient with history of gastrectomy

12. Patient with uncontrolled diabetes mellitus or unmonitored diabetes mellitus

13. Patient with cachexia caused by other reasons, as determined by the investigator such
as:

1. Severe COPD requiring use of home O2,

2. New York Heart Association (NYHA) class III-IV heart failure

3. AIDS

4. Uncontrolled thyroid disease

14. Patient receiving strong CYP3A4 inhibitors within 14 days of randomization

15. Patient currently receiving tube feedings or parenteral nutrition (either total or
partial).

16. Current excessive alcohol or illicit drug use

17. Any condition, including the presence of laboratory abnormalities, which in the
Investigator's opinion, places the subject at unacceptable risk if he/she were to
participate in the study or confounds the ability to interpret data from the study

18. Enrollment in a previous study with anamorelin HCl

19. Patient actively receiving a concurrent investigational agent, or having received an
investigational agent within 28 days of Day 1 All exclusion criteria will be checked
at screening visit (Visit 1).

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
18/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/12/2022
Sample size
Target
Accrual to date
Final
318
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Calvary Central Districts Hospital - Elizabeth Vale
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [4] 0 0
Barwon Health, The McKellar Centre - North Geelong
Recruitment hospital [5] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [6] 0 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3215 - North Geelong
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
4215 - Southport
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
New Hampshire
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
Belgium
State/province [15] 0 0
Brussels
Country [16] 0 0
Belgium
State/province [16] 0 0
Charleroi
Country [17] 0 0
Belgium
State/province [17] 0 0
Edegem
Country [18] 0 0
Belgium
State/province [18] 0 0
Roeselare
Country [19] 0 0
Croatia
State/province [19] 0 0
Pula
Country [20] 0 0
Croatia
State/province [20] 0 0
Split
Country [21] 0 0
Croatia
State/province [21] 0 0
Zagreb
Country [22] 0 0
Poland
State/province [22] 0 0
Grudziadz
Country [23] 0 0
Poland
State/province [23] 0 0
Katowice
Country [24] 0 0
Poland
State/province [24] 0 0
Poznan
Country [25] 0 0
Poland
State/province [25] 0 0
Prabuty
Country [26] 0 0
Poland
State/province [26] 0 0
Warsaw
Country [27] 0 0
Poland
State/province [27] 0 0
Wieliszew
Country [28] 0 0
Poland
State/province [28] 0 0
Lódz
Country [29] 0 0
Romania
State/province [29] 0 0
Cluj County
Country [30] 0 0
Romania
State/province [30] 0 0
Dolj County
Country [31] 0 0
Romania
State/province [31] 0 0
Maramures
Country [32] 0 0
Romania
State/province [32] 0 0
Murers
Country [33] 0 0
Romania
State/province [33] 0 0
Suceava County
Country [34] 0 0
Romania
State/province [34] 0 0
Timis
Country [35] 0 0
Romania
State/province [35] 0 0
Bucharest
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Kazan
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Pyatigorsk
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Saint Petersburg
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Samara
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Saransk
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Sochi
Country [42] 0 0
Russian Federation
State/province [42] 0 0
St. Petersburg
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Volgograd
Country [44] 0 0
Ukraine
State/province [44] 0 0
Kharkiev Region
Country [45] 0 0
Ukraine
State/province [45] 0 0
Kharkiev
Country [46] 0 0
Ukraine
State/province [46] 0 0
Kyviv
Country [47] 0 0
Ukraine
State/province [47] 0 0
Poltava Region
Country [48] 0 0
Ukraine
State/province [48] 0 0
Dnipro
Country [49] 0 0
Ukraine
State/province [49] 0 0
Kyiv
Country [50] 0 0
Ukraine
State/province [50] 0 0
Ternopil'
Country [51] 0 0
Ukraine
State/province [51] 0 0
Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Helsinn Healthcare SA
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate
the efficacy and safety of anamorelin HCl. Approximately 316 patients with advanced NSCLC
with cachexia will be randomized 1:1 to anamorelin HCl 100 mg or placebo, taken orally once
daily (QD) for a total of 24 weeks. Patients will be instructed to take the study drug at
least 1 hour before their first meal of the day
Trial website
https://clinicaltrials.gov/ct2/show/NCT03743064
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03743064