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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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% higher). 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).
Primary Outcome
Part A - To dose escalate EC1456 dose until maximum tolerated dose (MTD) and recommended Phase 2 (RP2) dose for multiple schedules is reached. -All patients who receive at least one dose of EC1456 will be evaluated for safety. All AEs and SAEs will be graded as per CTCAE V4.0. For each dose level, summaries of dose adjustments, adverse event rates, laboratory changes, cumulative toxicity, and dose limiting toxicity (DLT) will be analyzed. Summaries of CTCAE grades will be analyzed at each dose
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 |
What the finished NCT01999738 record still lists
NCT01999738 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% higher).
The record links to 0 conditions, and to 1 intervention - of which EC1456 and EC20 is the first listed.
NCT01999738 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01999738's enrollment target sits among peer trials
93 624th of 2000 higher than 1,376 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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