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A Study of Olaratumab (IMC-3G3) in Previously Treated Participants With Unresectable and/or Metastatic Gastrointestinal Stromal Tumors

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.
 
ClinicalTrials.gov Identifier: NCT01316263
Recruitment Status : Terminated (Trial terminated strategically due to poor accrual.)
First Posted : March 16, 2011
Results First Posted : January 16, 2017
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The purpose of this study is to evaluate the tumor response of stable disease (SD), partial response (PR), or complete response (CR) [according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1 criteria)] at 12 weeks in participants with Gastrointestinal Stromal Tumors (GIST) harboring platelet-derived growth factor receptor alpha (PDGFRα) mutations and patients with GIST not harboring PDGFRα mutations.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumor (GIST) Biological: Olaratumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of a Human Anti-PDGFRα Monoclonal Antibody (IMC-3G3) in Previously Treated Patients With Unresectable and/or Metastatic Gastrointestinal Stromal Tumors (GIST)
Study Start Date : August 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Olaratumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: PDGFRα mutation negative
Participants with GIST with genotypes that do not have a PDGFRα mutation given 20 milligrams per kilogram (mg/kg) Olaratumab intravenously (IV) every 14 days.
 Biological: Olaratumab
Administered IV
Other Names:
  • LY3012207
  • IMC-3G3
Experimental: PDGFRα mutation positive
Participants with GIST with genotypes that have a PDGFRα mutation given 20 mg/kg Olaratumab IV every 14 days.
 Biological: Olaratumab
Administered IV
Other Names:
  • LY3012207
  • IMC-3G3


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Tumor Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate) at 12 Weeks [ Time Frame: 12 weeks ]
    Clinical benefit was defined as CR, PR, or SD using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST, v1.1) criteria. CR: disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). PR: ≥30% decrease in sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. SD: neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. PD: increase ≥20% in sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). Sum must also have demonstrated an absolute increase of ≥5 mm, or appearance of 1 or more new lesions was considered progression. Percentage of participants=(participants with CR+PR+SD/participants in group) *100.


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Baseline to the first date of objectively determined PD or death from any cause up to 35.9 weeks ]
    PFS defined as the duration from date of first dose of study drug until first radiographic documentation of PD using RECIST, v1.1 criteria or death from any cause. PD defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm and the appearance of ≥1 new lesions was progression. Participants who died with no prior PD were considered to have progressed on day of death. Participants who did not progress or were lost to follow-up were censored at date of last radiographic tumor assessment; if no assessment was available censoring was at date of registration. If death or PD occurred after 2 consecutive missing radiographic visits censoring was date of last radiographic visit prior to missed visits. Use of new anticancer therapy prior to PD, censoring was date of last radiographic assessment prior to new therapy.

  2. Percentage of Participants With CR or PR [Radiographic Objective Response Rate (ORR)] [ Time Frame: Baseline up to 35.9 weeks and post study discontinuation 30-day follow-up ]
    The ORR was the best overall response of CR and PR using RECIST, v1.1 criteria. Participants who did not have a tumor response assessment for any reason were considered nonresponders and were included in the denominator that calculated the response rate. Percentage of participants = (number of participants achieving a response/total of participants treated) * 100.

  3. Overall Survival (OS) [ Time Frame: Date of first dose of study drug to the date of death from any cause up to 57.3 weeks ]
    OS was defined as the time from the date of first dose of study drug to the date of death from any cause. Participants who were alive at the end of the post-study follow-up or were lost to follow-up were censored on the last date the participant was known to be alive.

  4. Number of Participants With Adverse Events (AE) and Participants Who Died [ Time Frame: Baseline up to 57.3 weeks and 30-day post study-discontinuation follow-up ]
    Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs, regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. The number of participants who died due to an AE or disease progression are also reported.

  5. Percentage of Participants With CR, PR or SD [Disease Control Rate (DCR)] [ Time Frame: Baseline up to 35.9 weeks ]
    DCR defined as CR, PR or SD using RECIST v1.1 criteria. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR was defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify PD, taking as reference the smallest sum diameter since the treatment started. PD defined as ≥20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Sum must also have demonstrated an absolute increase of ≥5 mm, or the appearance of 1 or more new lesions was considered progression. Percentage of participants=(number of participants with CR+PR+SD/number of participants in group) * 100.

  6. Maximum Concentration (Cmax) [ Time Frame: Day 1 of Cycles 1 and 3 (14-day cycles) ]
  7. Area Under the Curve (AUC) [ Time Frame: Day 1 of Cycles 1 and 3 (14-day cycles) ]
  8. Half Life (t½) [ Time Frame: Day 1 of Cycles 1 and 3 (14-day cycles) ]
  9. Clearance (CL) [ Time Frame: Day 1 of Cycles 1 and 3 (14-day cycles) ]
  10. Volume of Distribution at Steady State (Vss) [ Time Frame: Day 1 of Cycles 1 and 3 (14-day cycles) ]
  11. Percentage of Participants With Human Anti-Olaratumab (IMC-3G3) Antibody Results [ Time Frame: Day 1 of Cycles 1, 3, 6, 12 and 18 prior to infusion (14-day cycles) ]
    Participants with Treatment Emergent (TE) anti-olaratumab (IMC-3G3) antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant has histologically or cytologically confirmed, unresectable and/or metastatic GIST
  • Participant has measurable disease
  • Participant has documented objective progression following, or intolerance to, treatment with both imatinib and sunitinib
  • Participant's Eastern Cooperative Oncology Group (ECOG) performance status (PS) is 0 to 2

  • Participant has either:

    1. prior results from growth factor receptor associated with tyrosine kinase activity (KIT) and PDGFRα mutation analysis that meet analytical criteria as defined for the on-study analysis of these mutations and tumor tissue (from either primary or metastatic tumor) that can be submitted for analysis within 30 days after the first dose of study therapy; or
    2. if prior results from KIT and PDGFRα mutation analysis are not available or do not meet analytical criteria as above, then tumor tissue (from either primary or metastatic tumor) must be submitted for genotype testing at the latest 28 days prior to the first dose of study therapy
  • Participant has adequate hematologic, hepatic, renal and coagulation function
  • Women of childbearing potential and sexually active males must agree to use adequate contraception prior to study and for at least 12 weeks after the last dose of IMC-3G3
  • Participant has a life expectancy of ≥ 3 months

Exclusion Criteria:

  • Participant has untreated central nervous system metastases, and as a result, is clinically unstable with regard to neurologic function
  • Participant has a history of another primary cancer
  • Participant has received any investigational therapy within 14 days prior to registration, or is currently enrolled in any other type of medical research
  • Participant is receiving concurrent treatment with other anticancer therapy
  • Participant has known human immunodeficiency virus (HIV) infection
  • Participant has undergone major surgery within 28 days prior to registration
  • If female, participant is pregnant or breastfeeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01316263


Locations
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United States, Illinois
ImClone Investigational Site
Chicago, Illinois, United States, 60637
United States, Massachusetts
ImClone Investigational Site
Boston, Massachusetts, United States, 02215
Belgium
ImClone Investigational Site
Edegem, Belgium, B-2650
ImClone Investigational Site
Leuven, Belgium, B-3000
Germany
ImClone Investigational Site
Bad Saarow, Germany, 15526
ImClone Investigational Site
Berlin, Germany, 13125
ImClone Investigational Site
Essen, Germany, 45122
ImClone Investigational Site
Mannheim, Germany, 68167
ImClone Investigational Site
Tuebingen, Germany, 72076
Netherlands
ImClone Investigational Site
Leiden, Netherlands, 2300 RC
Poland
ImClone Investigational Site
Warsaw, Poland, 02-781
Spain
ImClone Investigational Site
Madrid, Spain, 28041
ImClone Investigational Site
Madrid, Spain, 28050
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01316263    
Other Study ID Numbers: 14244
CP15-1008 ( Other Identifier: ImClone, LLC )
I5B-IE-JGDH ( Other Identifier: Eli Lilly and Company )
2010-022560-12 ( EudraCT Number )
First Posted: March 16, 2011    Key Record Dates
Results First Posted: January 16, 2017
Last Update Posted: March 9, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Olaratumab
Antineoplastic Agents