Lung Cancer Clinical Trial

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)

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Signed written informed consent
Female or male ≥18 years of age
Documented histologic or cytologic diagnosis of American Joint Committee on Cancer (AJCC) Stage III or IV NSCLC. Stage III patient must have unresectable disease
Body mass index < 20 kg/m2 with involuntary weight loss of >2% within 6 months prior to screening
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

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:

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
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
Patient on palliative care treatment
ECOG performance status 0,1 or 2 at screening
AST (SGOT) and ALT (SGPT) ≤ 3 x ULN or if hepatic metastases are present ≤ 5 x ULN
Adequate renal function, defined as creatinine ≤2 ULN, or calculated creatinine clearance >30 ml/minute

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:

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

Exclusion Criteria:

Patient with other forms of lung cancer (e.g., small cell, neuroendocrine tumors)
Woman who is pregnant or breast-feeding

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

NCI CTCAE Grade 3 or 4 oral mucositis,
NCI CTCAE Grade 3 or 4 GI disorders [nausea, vomiting, diarrhea, and constipation],
mechanical obstructions making patient unable to eat, or
severe depression
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
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
Patient with pleural effusion requiring thoracentesis, pericardial effusion requiring drainage, edema or evidence of ascites

Patient with uncontrolled or significant cardiovascular disease, including:

History of myocardial infarction within the past 3 months
A-V block of second or third degree (may be eligible if currently have a pacemaker)
Unstable angina
Congestive heart failure within the past 3 months, if defined as NYHA class III-IV
Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW) syndrome, or torsade de pointes)
Uncontrolled hypertension (blood pressure >150 mm Hg systolic and >95 mm Hg diastolic)
Heart rate < 50 beats per minute on pre-entry electrocardiogram and patient is symptomatic
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)
Patient unable to readily swallow oral tablets
Patient with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption)
Patient with history of gastrectomy
Patient with uncontrolled diabetes mellitus or unmonitored diabetes mellitus

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

Severe COPD requiring use of home O2,
New York Heart Association (NYHA) class III-IV heart failure
AIDS
Uncontrolled thyroid disease
Patient receiving strong CYP3A4 inhibitors within 14 days of randomization
Patient currently receiving tube feedings or parenteral nutrition (either total or partial).
Current excessive alcohol or illicit drug use
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
Enrollment in a previous study with anamorelin HCl
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 is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

318

Study ID:

NCT03743064

Recruitment Status:

Active, not recruiting

Sponsor:

Helsinn Healthcare SA

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 65 Locations for this study

See Locations Near You

The university of Arizona Cancer Center - North Campus
Tucson Arizona, 85719, United States
Pacific Cancer Medical Center, Inc
Anaheim California, 92801, United States
CBCC Global Research Inc
Bakersfield California, 93309, United States
Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.
Fountain Valley California, 92708, United States
Marin cancer Care
Greenbrae California, 94904, United States
Smilow Cancer Hospital at Yale-New Haven
Waterbury Connecticut, 06708, United States
Bond & Steele Clinic P.A.
Winter Haven Florida, 33881, United States
Presence Infusion Care
Skokie Illinois, 60077, United States
Siouxland Regional cancer Center dba June E.Nylen Cancer Center
Sioux City Iowa, 51101, United States
Cancer Center of Kansas
Wichita Kansas, 67214, United States
Cancer and Hematology Centers Of Western Michigan
Grand Rapids Michigan, 49503, United States
Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
New Jersey Hematology Oncology associates Inc
Brick New Jersey, 08724, United States
Hunterdon hematology Oncology LLC
Flemington New Jersey, 08822, United States
Hematology Oncology Center at Nyack Hospital
Nyack New York, 10960, United States
University of Rochester, Medical Center
Rochester New York, 14642, United States
Duke Cancer Center
Durham North Carolina, 27710, United States
Toledo Clinic Cancer center-Toledo
Toledo Ohio, 43623, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Calvary Central Districts Hospital
Elizabeth Vale South Australia, 5112, Australia
Flinders Medical Centre
Bedford Park , 5042, Australia
St Vincent's Hospital Melbourne
Fitzroy , 3065, Australia
Barwon Health, The McKellar Centre
North Geelong , 3215, Australia
The Royal Melbourne Hospital
Parkville , 3050, Australia
Gold Coast University Hospital
Southport , 4215, Australia
Jules Bordet Institut
Brussels , 1000, Belgium
Saint Luc University Hospital
Brussels , 1200, Belgium
Charleroi Grand Hospital (GHDC)
Charleroi , 6000, Belgium
University Hospital Antwerp (UZA)
Edegem , 2650, Belgium
General Hospital Delta
Roeselare , 8800, Belgium
General Hospital Pula
Pula , 52 10, Croatia
University Hospital Center Split
Split , 21000, Croatia
University Hospital Center Zagreb
Zagreb , 10000, Croatia
Wladyslaw Bieganski Regional Specialist Hospital, Clnical Oncology Department
Grudziądz , 86-30, Poland
"VEGAMED" Non-Public Healthcare Facility
Katowice , 40-06, Poland
MED - POLONIA Ltd.
Poznań , 60-69, Poland
Specialist Hospital in Prabuty sp. z o.o. [limited liability company], Department of Pulmonology
Prabuty , 82-55, Poland
Maria Skfodowska-Curie Institute of Oncology, Department of Lung and Thoracic Cancers
Warsaw , 02-78, Poland
Mazovian Oncology Hospital, Oncology Outpatient Clinic
Wieliszew , 05-13, Poland
MSF Institute Ltd. Santa Familia Medical Institute
Łódź , 90-30, Poland
"Prof. Dr. Ion Chiricuta" Institute of Oncology, Medical Oncology Department
Cluj-Napoca Cluj County, 40001, Romania
"Sf. Nectarie" Oncology center, Medical Oncology department
Craiova Dolj County, 20034, Romania
SC Oncopremium team SRL, Medical oncology department
Baia Mare Maramures, 43029, Romania
Topmed Medical center, Medical Oncology Department
Târgu-Mureş Murers, 54015, Romania
Sf. Ioan cel Nou Country Emergency Hospital, Oncology department
Suceava Suceava County, 72023, Romania
S.C. Oncomed SRL, Medical Oncology Department
Timisoara Timis, 30023, Romania
Alexandru Trestioreanu Institute of Oncology
Bucharest , 02232, Romania
Republican Clinical Oncology Center
Kazan , 42002, Russian Federation
Pyatigorsk Interdistric Oncology Center
Pyatigorsk , 35750, Russian Federation
Oncology Center of Moskovskiy District
Saint Petersburg , 19624, Russian Federation
AV Medical Group
Saint Petersburg , 19708, Russian Federation
City Clinical Oncology Center
Saint Petersburg , 19825, Russian Federation
Samara Regional clinical Oncology Center
Samara , 44303, Russian Federation
Ogaryov Mordovia National Research State University, Republican Oncology Center
Saransk , 43003, Russian Federation
Oncology Center #2
Sochi , 35405, Russian Federation
Palliative Care Center Devita
St. Petersburg , 19718, Russian Federation
Volgograd Regional Clinical Oncology Center
Volgograd , 40013, Russian Federation
Publ Non- Profit Ent. under Kharkiv Reg. Council
Kharkiv Kharkiev Region, 61166, Ukraine
Communal Non-Profit Enterprise "Regional Center of Oncology"
Kharkiv Kharkiev, 61070, Ukraine
Medical Center "VERUM" Limited Liability Company
Kyiv Kyviv, 3039, Ukraine
Public Entreprise "Poltava Regional Clinical oncology Center under Poltava Regional Council"
Poltava Poltava Region, 36011, Ukraine
Medical Center "MEDICAL PLAZA" of the Limited Liability Company "EKODNIPRO"
Dnipro , 49055, Ukraine
Private Enterprise "First Private Clinic"
Kyiv , 03037, Ukraine
Public Non-Profit Enterprise 'Ternopil Regional Clini cal Oncology Center'' under Temopil Regional Counci l
Ternopil' , 46023, Ukraine
Medical Center of Limited Liability Company "ONCOLIFE"
Zaporizhzhya , 69059, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

318

Study ID:

NCT03743064

Recruitment Status:

Active, not recruiting

Sponsor:


Helsinn Healthcare SA

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.