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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02659020
First received: January 15, 2016
Last updated: April 19, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Soft Tissue Sarcoma
Drug: Olaratumab
Drug: Gemcitabine
Drug: Docetaxel
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Recommended Phase 2 Dose of Olaratumab: Number of Participants with Dose Limiting Toxicity (DLT) [ Time Frame: Cycle 1 (21 Days) ]
  • Overall Survival (OS) [ Time Frame: Baseline to Date of Death Due to Any Cause (Approximately 15 Months) ]

Secondary Outcome Measures:
  • Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab [ Time Frame: Post-dose on Days 1 and 8 of Cycles 1 and 3 (21 day cycles) ]
  • PK: Minimum Serum Concentration (Cmin) of Olaratumab [ Time Frame: Pre-dose on Day 8 of Cycles 1 and 3, and on Day 1 of Cycles 2 and 4 ]
  • PK: Elimination Half-Life (T1/2) of Olaratumab [ Time Frame: Days 8 to 21 of Cycles 1 and 3 ]
  • Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death from Any Cause (Approximately 6 Months) ]
  • Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR]) [ Time Frame: Baseline to Objective Progression or Start of New Anti-Cancer Therapy (Approximately 6 Months) ]
  • Disease Control Rate (DCR): Defined as Proportion of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) [ Time Frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 6 Months) ]
  • Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score" [ Time Frame: Baseline through Follow-up (Approximately 6 Months) ]
  • Time to Sustained Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scale Scores [ Time Frame: Baseline through Follow-up (Approximately 6 Months) ]
  • Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L) [ Time Frame: Baseline through Follow-up (Approximately 6 Months) ]

Estimated Enrollment: 211
Study Start Date: March 2016
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olaratumab + Gemcitabine + Docetaxel (Dose Escalation)
Olaratumab intravenously (IV) on day 1 and day 8 of each cycle (1 cycle = 21 days) with gemcitabine IV on day 1 and 8 and docetaxel IV on day 8. Participants may continue to receive treatment until discontinuation criteria are met.
Drug: Olaratumab
Administered IV
Other Names:
  • LY3012207
  • IMC-3G3
Drug: Gemcitabine
Administered IV
Other Names:
  • LY188011
  • Gemzar
Drug: Docetaxel
Administered IV
Experimental: Olaratumab + Gemcitabine + Docetaxel
Olaratumab IV on day 1 and day 8 of each cycle (1 cycle = 21 days) with gemcitabine IV on day 1 and 8 and docetaxel IV on day 8. Participants may continue to receive treatment until discontinuation criteria are met.
Drug: Olaratumab
Administered IV
Other Names:
  • LY3012207
  • IMC-3G3
Drug: Gemcitabine
Administered IV
Other Names:
  • LY188011
  • Gemzar
Drug: Docetaxel
Administered IV
Placebo Comparator: Placebo + Gemcitabine + Docetaxel
Placebo IV on day 1 and day 8 of each cycle (1 cycle = 21 days) with gemcitabine IV on day 1 and 8 and docetaxel IV on day 8. Participants may continue to receive treatment until discontinuation criteria are met.
Drug: Gemcitabine
Administered IV
Other Names:
  • LY188011
  • Gemzar
Drug: Docetaxel
Administered IV
Drug: Placebo
Administered IV

  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  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: NCT02659020

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 50 Study Locations
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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02659020     History of Changes
Other Study ID Numbers: 15839
I5B-MC-JGDL ( Other Identifier: Eli Lilly and Company )
2015-001316-34 ( EudraCT Number )
Study First Received: January 15, 2016
Last Updated: April 19, 2017

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Docetaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on May 22, 2017