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NCT01608867 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation Study of OMP-54F28 in Subjects With Solid Tumors
A Phase 1 study, sponsored by OncoMed Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT01608867 is a Phase 1 study that has completed, run by OncoMed Pharmaceuticals. The registered enrollment target is 26 participants.
The verdict
NCT01608867, a Phase 1 study, has completed, sponsored by OncoMed Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This is an open-label Phase 1 dose escalation study of OMP-54F28 in subjects with a solid tumor for which there is no remaining standard curative therapy. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. No formal interim analyses will be performed. Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon enrollment, subjects will receive OMP-54F28 until disease progression. All subjects will receive Vitamin D3 daily and calcium carbonate twice daily from Day 0 through 30 days following the discontinuation of OMP-54F28. Dose escalation will be conducted to determine the maximum tolerated dose (MTD). Subjects will be dosed at 0.5, 1, 2.5, 5, and 10 mg/kg administered IV once every 3 weeks. No dose escalation or reduction will be allowed within a dose cohort. Intermediate doses (i.e., doses between the dose levels listed above) may also be tested upon agreement with the investigators and the study sponsor. In addition, alternate dosing schedule cohorts of OMP-54F28 (eg. every 4 week or every 6 week dosing) can be studied upon agreement with the investigators and the study sponsor. These alternative less frequent dosing schedules may be evaluated if emerging data suggest that once every 3 week dosing results in tolerability concerns. The first 2 subjects enrolled in a cohort will not be treated on the same day. The dose may be administered at any time during the day. Three subjects will be treated at each dose level if no dose-limiting toxicities (DLTs) are observed. If 1 of 3 subjects experiences a DLT, that dose level will be expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be dosed at that level and 3 additional subjects will be added to the preceding dose cohort unless 6 subjects have already been treated at that dose level. Subjects will be assessed for DLTs from Days 0-28. Dose escalation for newly enrolled subjects, if appropriate, will occ
Interventions
- BIOLOGICAL OMP-54F28
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2012-06 |
| Est. Completion | 2017-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01608867
The ClinicalTrials.gov registry entry for NCT01608867 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OncoMed Pharmaceuticals, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which OMP-54F28 is the first listed.
NCT01608867 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01608867 about?
NCT01608867 is a clinical study titled "A Dose Escalation Study of OMP-54F28 in Subjects With Solid Tumors". This is an open-label Phase 1 dose escalation study of OMP-54F28 in subjects with a solid tumor for which there is no remaining standard curative therapy. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. No formal interim analyses will be performed. ...
What is the current status of trial NCT01608867?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2012-06. Estimated completion is 2017-06.
What interventions are being tested in trial NCT01608867?
The interventions under investigation include: OMP-54F28 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01608867?
This trial is sponsored by OncoMed Pharmaceuticals, which has 25 total clinical trials registered on ClinicalTrials.gov.
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