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Gastrointestinal Stromal Tumor (GIST)Phase 2NCT01316263

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

A Phase 2 study testing Olaratumab in people with Gastrointestinal Stromal Tumor (GIST), run by Eli Lilly and Company at 13 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Stromal Tumor (GIST)
What is being tested?
Olaratumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
13 sitesin 6 countries
Study dates
Aug 2011to Nov 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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
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  • 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

Who cannot join

  • 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

Trial locations and contacts

13 sites in 6 countries.

13 sites in 6 countries

Germany5 sites

  • ImClone Investigational Site

    Bad Saarow, 15526

  • ImClone Investigational Site

    Berlin, 13125

  • ImClone Investigational Site

    Essen, 45122

  • ImClone Investigational Site

    Mannheim, 68167

  • ImClone Investigational Site

    Tübingen, 72076

Other trials in Germany

United States2 sites

  • ImClone Investigational Site

    Boston, Massachusetts, 02215

  • ImClone Investigational Site

    Chicago, Illinois, 60637

Other trials in United States

Belgium2 sites

  • ImClone Investigational Site

    Edegem, B-2650

  • ImClone Investigational Site

    Leuven, B-3000

Other trials in Belgium

Spain2 sites

  • ImClone Investigational Site

    Madrid, 28041

  • ImClone Investigational Site

    Madrid, 28050

Other trials in Spain

Netherlands1 site

  • ImClone Investigational Site

    Leiden, 2300 RC

Other trials in Netherlands

Poland1 site

  • ImClone Investigational Site

    Warsaw, 02-781

Other trials in Poland

About this study

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)

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.

Being tested
Olaratumab
Medical subject headings
Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlaratumabBiological

    Also called LY3012207, IMC-3G3

    Administered IV

Study groups in NCT01316263
Study groupRoleWhat they receive
PDGFRα mutation negativeExperimentalParticipants with GIST with genotypes that do not have a PDGFRα mutation given 20 milligrams per kilogram (mg/kg) Olaratumab intravenously (IV) every 14 days.
Receives: Biological: Olaratumab
PDGFRα mutation positiveExperimentalParticipants with GIST with genotypes that have a PDGFRα mutation given 20 mg/kg Olaratumab IV every 14 days.
Receives: Biological: Olaratumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Tumor Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate) at 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.

    Measured: 12 weeks

Secondary outcomes (11)

  1. Progression-Free Survival (PFS)

    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.

    Measured: Baseline to the first date of objectively determined PD or death from any cause up to 35.9 weeks

  2. Percentage of Participants With CR or PR [Radiographic Objective Response Rate (ORR)]

    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.

    Measured: Baseline up to 35.9 weeks and post study discontinuation 30-day follow-up

  3. Overall Survival (OS)

    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.

    Measured: Date of first dose of study drug to the date of death from any cause up to 57.3 weeks

  4. Number of Participants With Adverse Events (AE) and Participants Who Died

    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.

    Measured: Baseline up to 57.3 weeks and 30-day post study-discontinuation follow-up

  5. Percentage of Participants With CR, PR or SD [Disease Control Rate (DCR)]

    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.

    Measured: Baseline up to 35.9 weeks

  6. Maximum Concentration (Cmax)

    Measured: Day 1 of Cycles 1 and 3 (14-day cycles)

  7. Area Under the Curve (AUC)

    Measured: Day 1 of Cycles 1 and 3 (14-day cycles)

  8. Half Life (t½)

    Measured: Day 1 of Cycles 1 and 3 (14-day cycles)

  9. Clearance (CL)

    Measured: Day 1 of Cycles 1 and 3 (14-day cycles)

  10. Volume of Distribution at Steady State (Vss)

    Measured: Day 1 of Cycles 1 and 3 (14-day cycles)

  11. Percentage of Participants With Human Anti-Olaratumab (IMC-3G3) Antibody Results

    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.

    Measured: Day 1 of Cycles 1, 3, 6, 12 and 18 prior to infusion (14-day cycles)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionMay 2012
  4. Study completionNov 2012

Why it stopped: Trial terminated strategically due to poor accrual.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01316263
Sponsor's protocol ID
14244
Other IDs
CP15-1008, I5B-IE-JGDH, 2010-022560-12
Status last verified
Jan 2017
First submitted
14 Mar 2011
Last updated
9 Mar 2017
Data monitoring committee
No

Publications

  • Wagner AJ, Kindler H, Gelderblom H, Schoffski P, Bauer S, Hohenberger P, Kopp HG, Lopez-Martin JA, Peeters M, Reichardt P, Qin A, Nippgen J, Ilaria RL, Rutkowski P. A phase II study of a human anti-PDGFRalpha monoclonal antibody (olaratumab, IMC-3G3) in previously treated patients with metastatic gastrointestinal stromal tumors. Ann Oncol. 2017 Mar 1;28(3):541-546. doi: 10.1093/annonc/mdw659.

    PubMed 28426120

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olaratumab in people with Gastrointestinal Stromal Tumor (GIST), run by Eli Lilly and Company at 13 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany, United States, Belgium, Spain, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01316263, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.

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