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NCT01999738 · ClinicalTrials.gov registry record · Phase 1
Folic Acid-Tubulysin Conjugate EC1456 In Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Endocyte.
- Completed
- Registry status
- Phase 1
- Development phase
- 93
- Enrollment target
NCT01999738: Completed Phase 1 study, sponsored by Endocyte.
NCT01999738 is a Phase 1 study that has completed, run by Endocyte. The registered enrollment target is 93 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01999738, a Phase 1 study, has completed, sponsored by Endocyte.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 93 participants
- Enrollment target
Study Summary
Phase 1A/B, multicenter, open-label, non-randomized, dose-escalation oncology study to evaluate the administration of EC1456 in advanced solid tumors. In part A, EC1456 will be dose escalated on 4 concurrently enrolling schedules. FR-positive expression on a 99mTc-etarfolatide scan is not required for inclusion in Part A. Part B of the study will confirm the maximum tolerated dose (MTD) and the recommended Phase 2 (RP2) dose of EC1456, and evaluate the efficacy of EC1456 in NSCLC all subtype patient populations with FR-positive cancer in up to three schedules (i.e., twice weekly, once weekly, and four times weekly). FR-positive expression on a 99mTc-etarfolatide scan is required for inclusion in Part B. Minimum length of patient participation is anticipated to be 10 weeks (two 3-week cycles followed by a 30 day follow-up period).
Interventions
- DRUG EC1456 and EC20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2013-10 |
| Est. Completion | 2018-04-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01999738
The ClinicalTrials.gov registry entry for NCT01999738 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endocyte, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which EC1456 and EC20 is the first listed.
NCT01999738 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01999738 about?
NCT01999738 is a clinical study titled "Folic Acid-Tubulysin Conjugate EC1456 In Patients With Advanced Solid Tumors". Phase 1A/B, multicenter, open-label, non-randomized, dose-escalation oncology study to evaluate the administration of EC1456 in advanced solid tumors. In part A, EC1456 will be dose escalated on 4 concurrently enrolling schedules. FR-positive expression on a 99mTc-etarfolatide scan is not required f...
What is the current status of trial NCT01999738?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 93 participants. The study started on 2013-10. Estimated completion is 2018-04-26.
What interventions are being tested in trial NCT01999738?
The interventions under investigation include: EC1456 and EC20 (DRUG).
Who is sponsoring clinical trial NCT01999738?
This trial is sponsored by Endocyte, which has 18 total clinical trials registered on ClinicalTrials.gov.
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