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NCT02677116 · ClinicalTrials.gov registry record · Phase 1
A Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With Cancer
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
NCT02677116: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT02677116 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 68 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02677116, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
Study Summary
The main purpose of this study is to evaluate the safety of different doses of olaratumab and to determine which dose should be used for future pediatric studies. The present study is open to children with advanced cancer or cancer that has spread to another part of the body. The study has three parts. In the first two parts, a specific dose of olaratumab will be given in 21 day cycles, followed by one of three standard chemotherapy regimens. In the third part, a specific dose of olaratumab will be given with one of three standard chemotherapy regimens in 21 day cycles. Participants will only enroll in one part.
Primary Outcome
A dose limiting toxicity (DLT) was defined as an adverse event (AE) during the first 21 days that was possibly related to the study drug and fulfilled any of the following criteria using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0: CTCAE Grade 3 nonhematologic toxicity, grade 4 neutropenia that lasted longer than 2 weeks, grade ≥3 thrombocytopenia complicated by hemorrhage, and any hematologic toxicity that caused a cycle delay of \>1
Interventions
- DRUG Doxorubicin
- DRUG Vincristine
- DRUG Irinotecan
- DRUG Ifosfamide
- DRUG Olaratumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2016-08-29 |
| Est. Completion | 2019-04-03 |
| Phase | Phase 1 |
What the finished NCT02677116 record still lists
NCT02677116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 5 interventions - of which Doxorubicin is the first listed.
NCT02677116 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02677116 about?
NCT02677116 is a clinical study titled "A Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With Cancer". The main purpose of this study is to evaluate the safety of different doses of olaratumab and to determine which dose should be used for future pediatric studies. The present study is open to children with advanced cancer or cancer that has spread to another part of the body. The study has three par...
What is the current status of trial NCT02677116?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2016-08-29. Estimated completion is 2019-04-03.
What interventions are being tested in trial NCT02677116?
The interventions under investigation include: Doxorubicin (DRUG), Vincristine (DRUG), Irinotecan (DRUG), Ifosfamide (DRUG), Olaratumab (DRUG).
Who is sponsoring clinical trial NCT02677116?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02677116's enrollment target sits among peer trials
68 776th of 2000 higher than 1,219 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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