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:

316

Study ID:

NCT03743051

Recruitment Status:

Active, not recruiting

Sponsor:

Helsinn Healthcare SA

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There are 68 Locations for this study

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Chen
Tucson Arizona, 85745, United States
CARTI Cancer center
Little Rock Arkansas, 72205, United States
the oncology Insitute of Hope and Innovation
Riverside California, 92506, United States
Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut
Plainville Connecticut, 06062, United States
21st Century oncology
Jacksonville Florida, 32204, United States
mid Florida hematology and Oncology Center
Orange City Florida, 32763, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Joliet Oncology hematology Associates, Ltd
Joliet Illinois, 60435, United States
Goshen Center for Cancer Care
Goshen Indiana, 46526, United States
McFarland Clinic, PC
Ames Iowa, 50010, United States
MercyOne Waterloo Cancer Center
Waterloo Iowa, 50702, United States
Jackson oncology Associates, PLC
Jackson Minnesota, 39216, United States
trinitas comprehensive cancer center/Trinitas Regional Medical Center
Elizabeth New Jersey, 07207, United States
Englewood Health
Englewood New Jersey, 07631, United States
Broome Oncology LLC
Johnson City New York, 13790, United States
Northwell Health
Lake Success New York, 11042, United States
Stony Brook Cancer Center
Stony Brook New York, 11794, United States
Ohio State University Wexner Medical Center The James Cancer Hospital and Solove Research Institute
Columbus Ohio, 43210, United States
Gettysburg Cancer Center
Gettysburg Pennsylvania, 17325, United States
Tennessee Cancer Specialist
Knoxville Tennessee, 37909, United States
Community Cancer Trial of Utah
Ogden Utah, 84405, United States
Virginia Commonwealth University, Massey Cancer Center
Richmond Virginia, 23298, United States
Kadlec Clinic Hematology and Oncology
Kennewick Washington, 99336, United States
Wenatchee Valley Hospital & Clinics
Wenatchee Washington, 98801, United States
Department of Medical Oncology, Complex Oncology Center - Burgas, Burgas
Burgas , 8000, Bulgaria
Department of Medical Oncology, Multiprofile Hospital for Active Treatment- Dobrich, Dobrich
Dobrich , 9300, Bulgaria
Department of Medical Oncology, Multiprofile Hospital for Acti ve T reatment ··Dr. Tota Venkova" , Gabrovo
Gabrovo , 5300, Bulgaria
Department of Medical Oncology, Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda, Sofia
Sofia , 1407, Bulgaria
clinic of medical oncology,hospital Sveta marina
Varna , 9010, Bulgaria
Clinic on Medical oncology University Muliprofile Hospital for active treatment "Sveta Marina", Varna
Varna , 9010, Bulgaria
K o ran y i National Institute of Pulmo nol ogy, 6th D epartm ent of Pulmono logy
Budapest , H-112, Hungary
University o f D ebrecen C linical Center, Department of Pulmono log y
Debrecen , H-403, Hungary
Veszprem C ounty Pulmonology I nstitute
Farkasgyepű , 1-1-8, Hungary
Clinical Center of the University of Pecs, Depaitment ofPulmonology
Pécs , H-762, Hungary
Fejer County St. Gyorgy University Teaching Hospital, Pulmonology Department I
Szekesfehervar , H-800, Hungary
Jasz-N agy kun-Szo l nok County H eteny i G eza Hospital-Clinic, Department of Oncology
Szolnok , H-500, Hungary
Pulmonology Institute Torokbalint
Törökbálint , H - 2, Hungary
University Hospital of Ferrara, Oncology department
Cona Ferrara, 44124, Italy
Scientific Institute of Romagna for the study and treatment of cancer (IRST)
Meldola Forli, 47014, Italy
Hospital Mater Salutis
Legnago Italia, 37045, Italy
Versilia Hospital
Lido Di Camaiore Italia, 55049, Italy
Hospital "Guglielmo da Saliceto"
Piacenza Italia, 29121, Italy
Oncology reference center
Aviano , 33081, Italy
Local Healthcare Company of Monza (ASST Monza)
Monza , 20900, Italy
AOU University Luigi Vanvitelli Oncoematology department
Napoli , 80131, Italy
Umberto I policlinico la Sapienza, Translational and Precision Medicine department
Roma , 00185, Italy
University Policlinic Fondation Agostino Gemelli
Rom , 00168, Italy
S.C. Pelican Impex S.R.L
Oradea Bihor, 41046, Romania
Medisprof S.R.L
Cluj Napoca Cluj, 40064, Romania
S.C. Onco Clinic Consult SA
Craiova Dolj, 20009, Romania
Mures County Clinical Hospital
Targu Mures Mures, 540 1, Romania
Ploiesti Municipal Hospital
Ploiesti Prahova, 10033, Romania
Oncocenter - Oncologie Clinica SRL
Timisoara Timis, 30016, Romania
National Medical Research Radiological Centre (Tsyb Medical Radiology Research Center)
Obninsk Kaluga Region, 24903, Russian Federation
Evimed, LLC
Chelyabinsk , 45404, Russian Federation
lvanovo Regional Oncology Center
Ivanovo , 15304, Russian Federation
Primushko Republicun Clinical Oncology Center
Izhevsk , 42600, Russian Federation
Immanuel Kant Baltic Federal University
Kaliningrad , 23601, Russian Federation
Kursk Regiona l Clinical Oncology Center
Kursk , 30552, Russian Federation
YitaMed, LLC
Moscow , 121 3, Russian Federation
University Headache Clinic
Moscow , 12146, Russian Federation
Clinical Oncology Center
Omsk , 64401, Russian Federation
Clinical Oncology Center
Omsk , 64404, Russian Federation
First I.P. Pavlov State Medical University of St. Petersburg
Saint Petersburg , 19702, Russian Federation
City Outpatient Clinic #43
Saint Petersburg , 19820, Russian Federation
Tambov Regional Oncological Clinical Center
Tambov , 39201, Russian Federation
Tomsk National Research Medical Center
Tomsk , 63402, Russian Federation
Clinical Center of Serbia, Clinic of Pulmonology
Belgrade , 11000, Serbia
Clinical Hospital Center lemnijsJca kosa
Belgrade , 11000, Serbia
Medical Military Academy
Belgrade , 11000, Serbia
Oncomed-System, Specialized Hospital for Internal Diseases
Belgrade , 11000, Serbia
Clinical Center K ragujevac
Kragujevac , 34000, Serbia

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

316

Study ID:

NCT03743051

Recruitment Status:

Active, not recruiting

Sponsor:


Helsinn Healthcare SA

How clear is this clinincal trial information?

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