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NCT02659020 · ClinicalTrials.gov registry record · Phase 1
A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma
A Phase 1 study of Soft Tissue Sarcoma, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 310
- Enrollment target
- 20
- Study locations
NCT02659020: Completed Phase 1 study of Soft Tissue Sarcoma, sponsored by Eli Lilly and Company.
NCT02659020 is a Phase 1 study of Soft Tissue Sarcoma that has completed, run by Eli Lilly and Company. The registered enrollment target is 310 participants, above the 73-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (325% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02659020, a Phase 1 study of Soft Tissue Sarcoma, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 310 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
A Dose Limiting Toxicity is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE Version 4.0: 1. Febrile neutropenia with documented Grade ≥3 infection or sepsis 2. Grade 4 neutropenia lasting 7 days or longer. 3. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by hemorrhage. 4. Nonhematologic Grade ≥3 toxicity, except for toxicities such as nausea, vomit
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Docetaxel
- DRUG Gemcitabine
- DRUG Olaratumab
Study Locations (20)
New York
- Monter Cancer Center - Lake Success
- Columbia University Medical Center - New York
- Memorial Sloan Kettering Cancer Center - New York
Florida
- Mayo Clinic-Jacksonville - Jacksonville
- Sylvester Comprehensive Cancer Center - Miami
Texas
- University of Texas Southwestern Medical Center at Dallas - Dallas
- University of Texas MD Anderson Cancer Center - Houston
California
- UCLA Medical Center - Santa Monica
Colorado
- University of Colorado Cancer Center - Aurora
Georgia
- Georgia Cancer Specialists PC - Atlanta
Maryland
- Johns Hopkins University School of Medicine - Baltimore
Massachusetts
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2016-03-01 |
| Est. Completion | 2021-04-27 |
| Phase | Phase 1 |
What the finished NCT02659020 record still lists
NCT02659020 is an interventional study that assigns participants to a tested intervention. The registered 310 participants enrollment target is mid-sized for trials with a published cap, above the 73-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (325% higher).
The record links to 1 condition, with Soft Tissue Sarcoma appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT02659020 names 20 study sites across 16 states, led by New York, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT02659020 about?
NCT02659020 is a clinical study titled "A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma". 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.
What is the current status of trial NCT02659020?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 310 participants. The study started on 2016-03-01. Estimated completion is 2021-04-27.
What conditions does trial NCT02659020 study?
This clinical trial studies the following conditions: Soft Tissue Sarcoma.
What interventions are being tested in trial NCT02659020?
The interventions under investigation include: Placebo (DRUG), Docetaxel (DRUG), Gemcitabine (DRUG), Olaratumab (DRUG).
Who is sponsoring clinical trial NCT02659020?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02659020 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Soft Tissue Sarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02659020's enrollment target sits among peer trials
310 3rd of 55 higher than 52 of 55 other Soft Tissue Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Soft Tissue Sarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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