A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer - Full Text View

Purpose

This phase 2 study is a multicenter, randomized, double-blind, placebo-controlled trial in participants with locally advanced/inoperable or metastatic pancreatic cancer, and will investigate 2 different doses of LY2495655 in combination with chemotherapy.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: LY2495655 Drug: Gemcitabine Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized Phase 2 Placebo-Controlled Study of LY2495655 in Patients With Advanced or Metastatic Pancreatic Cancer Receiving Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Overall survival [ Time Frame: Baseline to study completion (approximately 31 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of participants with tumor response (tumor response rate) [ Time Frame: Baseline to study completion (approximately 31 months) ] [ Designated as safety issue: No ]
Change in physical performance measures [ Time Frame: Baseline to study completion (approximately 31 months) ] [ Designated as safety issue: No ]
Change in patient reported outcomes [ Time Frame: Baseline to study completion (approximately 31 months) ] [ Designated as safety issue: No ]
Change in lean body mass [ Time Frame: Baseline to study completion (approximately 31 months) ] [ Designated as safety issue: No ]
Progression free survival (PFS) [ Time Frame: Baseline to study completion (approximately 31 months) ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: Baseline to study completion (approximately 31 months) ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	December 2011
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 300 mg LY2495655 + chemotherapy 300 mg LY2495655 intravenous (IV) in combination with gemcitabine-based (Gem-based) treatment in first line therapy.	Drug: LY2495655 Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops. Drug: Gemcitabine Intravenous (IV) treatment. Number of Cycles: until progression of disease or unacceptable toxicity develops. Other Names: Gemzar LY188011
Experimental: 100 mg LY2495655 + chemotherapy 100 mg LY2495655 intravenous (IV) in combination with gemcitabine-based (Gem-based) treatment in first line therapy.	Drug: LY2495655 Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops. Drug: Gemcitabine Intravenous (IV) treatment. Number of Cycles: until progression of disease or unacceptable toxicity develops. Other Names: Gemzar LY188011
Placebo Comparator: Placebo + chemotherapy Placebo in combination with gemcitabine-based (Gem-based) treatment in first-line therapy.	Drug: Gemcitabine Intravenous (IV) treatment. Number of Cycles: until progression of disease or unacceptable toxicity develops. Other Names: Gemzar LY188011 Drug: Placebo Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Unresectable or metastatic pancreas cancer; participants with previous radical surgery for pancreas cancer are eligible after progression is documented
Participants may have received previous adjuvant treatment with gemcitabine with or without radiotherapy for pancreas cancer
ECOG (Eastern Cooperative Oncology Group) 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

Exclusion:

Prior systemic therapy for unresectable/metastatic pancreas cancer
Any medical or psychiatric condition, orthopedic or neuromuscular conditions that could limit participation or confound study results
Currently taking medications that are considered both muscle building and performance enhancing (for example, androgen therapies, or anabolic steroids)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505530

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Show 29 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01505530 History of Changes
Other Study ID Numbers:	12552, I1Q-MC-JDDG
Study First Received:	January 4, 2012
Last Updated:	June 14, 2013
Health Authority:	United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products Canada: Health Canada Israel: Ministry of Health Norway: Norwegian Medicines Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on June 17, 2013