A Phase 2 Study in Patients with Pancreatic Cancer

Phase 1

• Conditions: Muscle wasting and weakness associated with cancer of the pancreas that is locally advanced or metastatic; MedDRA version: 14.1Level: LLTClassification code 10064015Term: Cancer cachexiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2011-003822-29-BE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-07
• Study Completion: 2015-12-28
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• Patients with unresectable or metastatic pancreas cancer
• ECOG Performance status = 2
• Adequate organ function
• Have an estimated life expectancy of at least 12 weeks and in the judgment of the investigator, will be able to complete at least 2 cycles of treatment
• Ability to perform the indicated functional performance measures at baseline.
• Females with child bearing potential must have a negative serum pregnancy test = 7 days prior to the first dose of study drug.
• Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months after discontinuation from study therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 95

Exclusion Criteria

• Have received prior systemic therapy for unresectable/metastatic pancreas cancer.
• Have underlying muscle disease or history of muscle disease
• Have evidence or recent history of significant psychiatric disease such as dementia/Alzheimer’s, schizophrenia, or bipolar disorder.
• Currently taking medications that are considered both muscle building and performance enhancing (for example, androgen therapies, or anabolic steroids)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified