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NCT03011320 · ClinicalTrials.gov registry record · Phase 1
An Exploratory Study of the Folic Acid-tubulysin Conjugate EC1456 in Ovarian Cancer Subjects Undergoing Surgery
A Phase 1 study, sponsored by Endocyte.
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT03011320: Completed Phase 1 study, sponsored by Endocyte.
NCT03011320 is a Phase 1 study that has completed, run by Endocyte. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03011320, a Phase 1 study, has completed, sponsored by Endocyte.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This study looks to enroll subjects with ovarian cancer who will be having standard of care surgery to remove ovarian cancer tumors. The main aim of this study is to be able to observe how EC1456 has been taken in and broken down inside tumors. The effect of EC1456 on the tumor will also be studied. This study will also help us compare the amount of EC1456 seen in tumors and how the tumors are imaged by the 99mTc-etarfolatide single-photon emission tomography (SPECT) or single-photon emission tomography with in-line x-ray computed tomography (SPECT/CT). All subjects will undergo a 99mTc-etarfolatide SPECT or SPECT/CT scan within 2 weeks prior to EC1456 administration. Individual subjects will then receive 1 of the following 2 doses of EC1456 pre-operatively: * 4 mg/m2 * 8 mg/m2 EC1456 will be administered at 1 of the following 2 time points: * \<8 hours before planned surgery * 48±4 hours before planned surgery Blood will be collected for pharmacokinetic (PK) studies right after EC1456 dosing and again right before surgery. At the time of surgery, tumor samples will be removed and sent to Endocyte for analysis.
Primary Outcome
Measure and characterize intratumoral levels of EC1456, and metabolites, by liquid chromatography-tandem mass spectrometry (LC-MS/MS). All results will be descriptive and exploratory.
Interventions
- DRUG EC1456
- DRUG 99mTc-Etarfolatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2017-01-24 |
| Est. Completion | 2018-08-28 |
| Phase | Phase 1 |
What the finished NCT03011320 record still lists
NCT03011320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which EC1456 is the first listed.
NCT03011320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03011320 about?
NCT03011320 is a clinical study titled "An Exploratory Study of the Folic Acid-tubulysin Conjugate EC1456 in Ovarian Cancer Subjects Undergoing Surgery". This study looks to enroll subjects with ovarian cancer who will be having standard of care surgery to remove ovarian cancer tumors. The main aim of this study is to be able to observe how EC1456 has been taken in and broken down inside tumors. The effect of EC1456 on the tumor will also be studied....
What is the current status of trial NCT03011320?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2017-01-24. Estimated completion is 2018-08-28.
What interventions are being tested in trial NCT03011320?
The interventions under investigation include: EC1456 (DRUG), 99mTc-Etarfolatide (DRUG).
Who is sponsoring clinical trial NCT03011320?
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 NCT03011320's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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