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A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01505530
First Posted: January 6, 2012
Last Update Posted: March 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
January 4, 2012
January 6, 2012
March 11, 2016
December 2011
October 2014   (Final data collection date for primary outcome measure)
Overall survival [ Time Frame: Baseline to study completion (approximately 31 months) ]
Same as current
Complete list of historical versions of study NCT01505530 on ClinicalTrials.gov Archive Site
  • 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) ]
Same as current
Not Provided
Not Provided
 
A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer
A Randomized Phase 2 Placebo-Controlled Study of LY2495655 in Patients With Advanced or Metastatic Pancreatic Cancer Receiving Chemotherapy
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: LY2495655
    Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.
  • Drug: Placebo
    Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.
  • Experimental: 300 mg LY2495655 + chemotherapy
    300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice)
    Intervention: Drug: LY2495655
  • Experimental: 100 mg LY2495655 + chemotherapy
    100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice)
    Intervention: Drug: LY2495655
  • Placebo Comparator: Placebo + chemotherapy
    Placebo in combination with standard of care chemotherapy (investigator's choice)
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
January 2016
October 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Israel,   Norway,   United Kingdom,   United States
Belgium
 
NCT01505530
12552
I1Q-MC-JDDG ( Other Identifier: Eli Lilly and Company )
No
Not Provided
Not Provided
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP