Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer

Helsinn Healthcare

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: anamorelin HCl; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00622193

ST-ANAM-207

Details and patient eligibility

About

The purpose of this study is to evaluate doses of anamorelin for safety and efficacy in patients with non-small cell lung cancer.

Full description

Cancer cachexia is a devastating, often late-stage complication of an underlying malignancy. Despite the significant importance of cancer-related cachexia, treatments are lacking and there are no products approved for this indication. Anamorelin HCl, by virtue of its ghrelin agonist activity, may serve a role in the treatment of cancer cachexia. This placebo controlled dose range study will evaluate the safety and efficacy of anamorelin HCl in patients with non-small cell lung cancer, a cancer associated with a high prevalence of cachexia.

Enrollment: 228 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• stage IIIB or IV NSCLC
• eligible for treatment of NSCLC with paclitaxel and carboplatin +/- bevacizumab

Exclusion criteria

• mixed large and small cell histologies for lung cancer
• significant obesity, BMI > 30

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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228 participants in 3 patient groups, including a placebo group

1 Active 50 mg

Experimental group

Treatment:

Drug: anamorelin HCl

Drug: anamorelin HCl

2 Active 100 mg

Experimental group

Treatment:

Drug: anamorelin HCl

Drug: anamorelin HCl

3 Placebo

Placebo Comparator group

Treatment:

Drug: placebo