NL-OMON37977
Completed
Phase 3
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 - Helsinn HT-ANAM-301 study (ROMANA 1)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- cachexia
- Sponsor
- Helsinn Therapeutics (U.S.), Inc
- Enrollment
- 2
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •Females and males at least 18 years of age
- •Documented histologic or cytologic diagnosis of AJCC Stage III or IV NSCLC. Stage III patients must have unresectable disease.
- •With regard to chemotherapy and/or radiation therapy:
- •o Patients may be receiving maintenance chemotherapy.
- •o Patients planning to initiate a new chemotherapy and/or radiation therapy
- •regimen may do so only within ±14 days of randomization.
- •o 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.
Exclusion Criteria
- •Other forms of lung cancer (eg, small cell, mesothelioma)
- •Women who are pregnant or breast\-feeding
- •Known HIV, hepatitis (B \& C), or active tuberculosis
- •Patients who are currently actively receiving chemotherapy and/or radiation therapy for disease treatment. Patients must not be planning to initiate chemotherapy and/or radiation therapy in the middle of the 12\-week treatment period at the time of randomization.
- •Had 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;
- •Patients unable to readily swallow oral tablets. Patients with severe gastrointestinal disease or intractable or frequent vomiting are excluded
- •Has an active, uncontrolled infection
- •Has uncontrolled diabetes mellitus
- •Has untreated clinically relevant hypothyroidism
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 3
Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer - Cachexia (NSCLC-C): An Extension Study;(ROMANA-3)cachexiewasting syndroom1000301810027656NL-OMON38190Helsinn Therapeutics (U.S.), Inc1
Completed
Phase 4
Individualized dosing of AMinoglycosides, quInolones and Glycopeptide antibiotics in (morbidly) Obese patients (AMIGO)(Morbid) obesityoverweight10004018NL-OMON46981Sint Antonius Ziekenhuis117
Completed
Not Applicable
MEDIASTINAL STAGING OF NON SMALL CELL LUNG CANCER BY ENDOBRONCHIAL AND ENDOSCOPIC ULTRASONOGRAPHY WITH OR WITHOUT ADDITIONAL SURGICAL MEDIASTINOSCOPY (MEDIASTrial)NL-OMON52981Maxima Medisch Centrum356
Completed
Phase 4
Post-Market Clinical Investigation of the Clareon® IONL-OMON46484Alcon Laboratories16
Completed
Not Applicable
Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of careNL-OMON38373niversitair Medisch Centrum Utrecht450