E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Muscle wasting and weakness associated with cancer of the pancreas that is locally advanced or metastatic |
|
E.1.1.1 | Medical condition in easily understood language |
Muscle loss and weakness associated with advanced pancreas cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Symptoms and general pathology [C23] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064015 |
E.1.2 | Term | Cancer cachexia |
E.1.2 | System Organ Class | 100000004861 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine if LY2495655 administered in combination with chemotherapy improves overall survival (OS), compared to chemotherapy in combination with placebo in patients with Stage II-IV unresectable pancreatic cancer |
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E.2.2 | Secondary objectives of the trial |
• To establish the safety of LY2495655 in combination with gemcitabine-based therapy or FOLFIRINOX in first-line treatment of pancreatic cancer
• To establish the safety of LY2495655 in combination with select post first-line treatment(s) for pancreatic cancer
• To compare the three treatment arms with respect to tumor response and time to event measures
• To explore changes in body composition (muscle and fat) and muscle volume as measured by DXA scan and CT scan over the course of the study
• To explore the effect of LY2495655 versus placebo on the following:
o Functional performance measures
o Patient reported outcomes
o Cardiac and pulmonary function
o Nutritional status |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients with unresectable or metastatic pancreas cancer
• Patients may have received previous adjuvant treatment with gemcitabine or a fluoropyrimidine-based therapy with or without radiotherapy for pancreas cancer. Adjuvant treatment must have finished at least 6 months before enrolling.
• 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. |
|
E.4 | Principal 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) |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 months after completion of enrollment |
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E.5.2 | Secondary end point(s) |
Response rate, duration of response and progression free survival measured per RECIST (v 1.1)
Body composition and muscle volume
Functional Performance measures
Pulmonary Function
ADL and Instrumental ADLs (IADLs)
Nutritional assessment |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 months after completion of enrollment |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
Canada |
Israel |
Norway |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |