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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03011320
The ClinicalTrials.gov registry entry for NCT03011320 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 3 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 2 interventions - of which EC1456 is the first listed.
NCT03011320 reports 0 study locations.
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.
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