Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01277146 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation Study of OMP-59R5 in Subjects With Solid Tumors
A Phase 1 study of Solid Tumors, sponsored by OncoMed Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 2
- Study locations
NCT01277146 is a Phase 1 study of Solid Tumors that has completed, run by OncoMed Pharmaceuticals. The registered enrollment target is 42 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (85% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT01277146, a Phase 1 study of Solid Tumors, has completed, sponsored by OncoMed Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is an open-label Phase 1 dose escalation study of OMP-59R5 in subjects with previously treated solid tumors for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2 centers. 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 intravenous (IV) infusions of OMP-59R5 at a assigned dosing schedule for 56 days. After 56 days, subjects will be assessed for disease status. If there is no evidence of disease progression or if the tumor is smaller, then subjects may continue to receive IV infusions of OMP-59R5 every week until disease progression. Dose escalation will be conducted to determine the maximum tolerated dose (MTD). No dose escalation or reduction will be allowed within a dose cohort. 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. The first 2 subjects in each cohort will not be started on OMP-59R5 on the same day. 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 the time of the first dose through 28 days. Dose escalation for newly enrolled subjects, if appropriate, will occur after all subjects in a cohort have completed their Day 28 DLT assessment. Subjects with stable disease or a response at Day 56 will be allowed to continue to receive weekly doses of OMP-59R5 unt
Conditions Studied
Interventions
- DRUG OMP-59R5
Study Locations (2)
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Texas
- South Texas Accelerated Research Therapeutics - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2010-12 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01277146
The ClinicalTrials.gov registry entry for NCT01277146 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (85% lower). The listed sponsor is OncoMed Pharmaceuticals, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which OMP-59R5 is the first listed.
NCT01277146 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Michigan, Texas.
Frequently Asked Questions
What is clinical trial NCT01277146 about?
NCT01277146 is a clinical study titled "A Dose Escalation Study of OMP-59R5 in Subjects With Solid Tumors". This is an open-label Phase 1 dose escalation study of OMP-59R5 in subjects with previously treated solid tumors for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2 centers. Subjects will be asse...
What is the current status of trial NCT01277146?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2010-12. Estimated completion is 2013-05.
What conditions does trial NCT01277146 study?
This clinical trial studies the following conditions: Solid Tumors.
What interventions are being tested in trial NCT01277146?
The interventions under investigation include: OMP-59R5 (DRUG).
Who is sponsoring clinical trial NCT01277146?
This trial is sponsored by OncoMed Pharmaceuticals, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01277146 being conducted?
This trial has 2 study locations across Michigan, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumors
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.
-
A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
A First-in-Human Study of BG-C0902 Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
Study of INCB123667 in Subjects With Advanced Solid Tumors
RECRUITING · Phase 1
-
JAB-2485 Activity in Adult Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
RECRUITING · Phase 1
-
Study of AUBE00 in Patients With Solid Tumors
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.