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A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01505530
First received: January 4, 2012
Last updated: February 10, 2016
Last verified: February 2016
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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 standard of care chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
| Pancreatic Cancer | Drug: LY2495655 Drug: Placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, 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:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Overall survival [ Time Frame: Baseline to study completion (approximately 31 months) ]
Secondary Outcome Measures:
- Percentage of participants with tumor response (tumor response rate) [ Time Frame: Baseline to study completion (approximately 31 months) ]
- Change in physical performance measures [ Time Frame: Baseline to study completion (approximately 31 months) ]
- Change in patient reported outcomes [ Time Frame: Baseline to study completion (approximately 31 months) ]
- Change in lean body mass [ Time Frame: Baseline to study completion (approximately 31 months) ]
- Progression free survival (PFS) [ Time Frame: Baseline to study completion (approximately 31 months) ]
- Duration of response [ Time Frame: Baseline to study completion (approximately 31 months) ]
| Enrollment: | 125 |
| Study Start Date: | December 2011 |
| Study Completion Date: | January 2016 |
| Primary Completion Date: | October 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 standard of care chemotherapy (investigator's choice)
|
Drug: LY2495655
Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.
|
|
Experimental: 100 mg LY2495655 + chemotherapy
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice)
|
Drug: LY2495655
Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.
|
|
Placebo Comparator: Placebo + chemotherapy
Placebo in combination with standard of care chemotherapy (investigator's choice)
|
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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505530
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505530
Locations
| United States, District of Columbia | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Washington, District of Columbia, United States | |
| United States, Texas | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Dallas, Texas, United States | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| The Woodlands, Texas, United States | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Tyler, Texas, United States | |
| United States, Washington | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Wenatchee, Washington, United States | |
| Canada, Alberta | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Calgary, Alberta, Canada | |
| Canada, Ontario | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Toronto, Ontario, Canada | |
| Israel | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Jerusalem, Israel | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Kfar Saba, Israel | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Petah Tiqva, Israel | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Tel Hashomer, Israel | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Tel-Aviv, Israel | |
| Norway | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Oslo, Norway | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Trondheim, Norway | |
| United Kingdom | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Cambridge, Cambridgeshire, United Kingdom | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| London, England, United Kingdom | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Southampton, Hants, United Kingdom | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Acton, London, United Kingdom | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Nottingham, Nottinghamshire, United Kingdom | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Edinburgh, Scotland, United Kingdom | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Cardiff, South Glamorgan, United Kingdom | |
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
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01505530 History of Changes |
| Other Study ID Numbers: |
12552 I1Q-MC-JDDG ( Other Identifier: Eli Lilly and Company ) |
| Study First Received: | January 4, 2012 |
| Last Updated: | February 10, 2016 |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on September 21, 2017