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NCT03283696 · ClinicalTrials.gov registry record · Phase 1
A Study of Olaratumab (LY3012207), Doxorubicin, and Ifosfamide in Participants With Advanced or Metastatic Soft Tissue Sarcoma
A Phase 1 study of Soft Tissue Sarcoma, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 6
- Study locations
NCT03283696: Completed Phase 1 study of Soft Tissue Sarcoma, sponsored by Eli Lilly and Company.
NCT03283696 is a Phase 1 study of Soft Tissue Sarcoma that has completed, run by Eli Lilly and Company. The registered enrollment target is 24 participants, below the 79-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (70% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03283696, a Phase 1 study of Soft Tissue Sarcoma, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to evaluate the safety of ifosfamide when added to the combination regimen of olaratumab and doxorubicin in participants with advanced or metastatic soft tissue sarcoma (STS).
Primary Outcome
A Dose Limiting Toxicity is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria, graded according to the NCI-CTCAE Version 4.0: 1. Grade 3 or 4 febrile neutropenia, or sepsis., or 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, vomiting, transient
Conditions Studied
Interventions
- DRUG Doxorubicin
- DRUG Mesna
- DRUG Ifosfamide
- DRUG Olaratumab
Study Locations (6)
Other
- HELIOS Klinikum Berlin-Buch - Berlin
- Università degli Studi di Catania - Azienda Policlinico - Catania
Florida
- University of Miami School of Medicine - Miami
Texas
- University of Texas MD Anderson Cancer Center - Houston
North Rhine-Westphalia
- Universitätsklinikum Essen - Essen
Lombardy
- Istituto Nazionale dei Tumori - Milan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-10-18 |
| Est. Completion | 2019-08-25 |
| Phase | Phase 1 |
What the finished NCT03283696 record still lists
NCT03283696 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 79-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Soft Tissue Sarcoma appearing as the primary indexed condition, and to 4 interventions - of which Doxorubicin is the first listed.
NCT03283696 lists 6 locations in 5 states (Other, Florida, Texas).
Frequently Asked Questions
What is clinical trial NCT03283696 about?
NCT03283696 is a clinical study titled "A Study of Olaratumab (LY3012207), Doxorubicin, and Ifosfamide in Participants With Advanced or Metastatic Soft Tissue Sarcoma". The purpose of this study is to evaluate the safety of ifosfamide when added to the combination regimen of olaratumab and doxorubicin in participants with advanced or metastatic soft tissue sarcoma (STS).
What is the current status of trial NCT03283696?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2017-10-18. Estimated completion is 2019-08-25.
What conditions does trial NCT03283696 study?
This clinical trial studies the following conditions: Soft Tissue Sarcoma.
What interventions are being tested in trial NCT03283696?
The interventions under investigation include: Doxorubicin (DRUG), Mesna (DRUG), Ifosfamide (DRUG), Olaratumab (DRUG).
Who is sponsoring clinical trial NCT03283696?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03283696 being conducted?
This trial has 6 study locations across Florida, Texas, North Rhine-Westphalia, Lombardy. 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 NCT03283696's enrollment target sits among peer trials
24 43rd of 55 higher than 11 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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