A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma

Official Title:

A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Gemcitabine and Docetaxel With or Without Olaratumab in the Treatment of Advanced Soft Tissue Sarcoma

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
Phase 1/Phase 2 Interventional 16 Years and older Eli Lilly and Company 15839
I5B-MC-JGDL
2015-001316-34
NCT02659020
Ongoing but not enrolling patients

Study Design:


Principal Investigator

Professor of Medicine
Chair, Data and Safety Monitoring Committee
Bonnie J. and Anthony Addario Endowed Chair in Thoracic Oncology
UCSF Helen Diller Family Comprehensive Cancer Center

Clinical Research Coordinator

UCSF Helen Diller Family Comprehensive Cancer Center
415-353-7912 Phone
(415) 353-9721 Fax

Trial Summary

The main purpose of this study is to evaluate the safety and efficacy of two anti-cancer drugs (gemcitabine and docetaxel) with and without the study drug known as olaratumab in participants with advanced soft tissue sarcoma (STS) or STS that has spread to another part(s) of the body.

Eligibility

Inclusion Criteria:
  • The participant may have no more than 2 prior lines of systemic therapies
    (neoadjuvant and adjuvant therapies will not be considered as a prior line of
    therapy) for advanced or metastatic disease and is suitable to receive gemcitabine
    and docetaxel therapy. All previous therapies must have completed ≥ 4 weeks (28 days)
    prior to enrollment (Phase 1b) / randomization (Phase 2).
  • Availability of tumor tissue is mandatory for study eligibility. The participant must
    have consented to provide archived formalin-fixed paraffin-embedded tumor tissue or
    be subject to a pre-treatment re-biopsy of primary or metastatic tumor tissue for
    future central pathology review and translational research (if archived tissue is
    unavailable).
  • The participant has adequate hematologic, organ, and coagulation function within 2
    weeks (14 days) prior to enrollment (Phase 1b) or randomization (Phase 2).
Exclusion Criteria:
  • The participant is diagnosed with gastrointestinal stromal tumor (GIST) or Kaposi
    sarcoma.
  • The participant has active central nervous system (CNS) or leptomeningeal metastasis
    (brain metastasis) at the time of enrollment (Phase 1b) or randomization (Phase 2).
    Participants with a history of a CNS metastasis previously treated with curative
    intent (for example, stereotactic radiation or surgery) that have not progressed on
    follow-up imaging, have been asymptomatic for at least 60 days, and are not receiving
    systemic corticosteroids and or/anticonvulsants, are eligible. Participants with
    signs or symptoms of neurological compromise should have appropriate radiographic
    imaging performed before enrollment (Phase 1b) /randomization (Phase 2) to rule out
    brain metastasis.
  • The participant has received prior treatment with gemcitabine, docetaxel, and/or
    olaratumab. Note: Participants previously enrolled in the I5B-MC-JGDJ (NCT02451943)
    or any other blinded study with olaratumab are not eligible to participate in this
    trial.
  • The participant has electively planned or will require major surgery during the
    course of the study.
  • Females who are pregnant or breastfeeding.
  • The participant has an active fungal, bacterial, and/or known viral infection
    including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis
    (screening is not required).

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 3/21/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
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