Phase 1Completed
An Exploratory Study of the Folic Acid-tubulysin Conjugate EC1456 in Ovarian Cancer Subjects Undergoing Surgery
An Exploratory, Open-label Study of the Folic Acid-tubulysin Conjugate EC1456 in Ovarian Cancer Subjects Undergoing Cytoreductive Surgery
- Sponsor
- Endocyte (Industry)
- Enrolment
- 3 enrolled
- Conditions
- Ovary Cancer
- Interventions
- EC1456; 99mTc-Etarfolatide
- Ages
- adults, older adults
- Registry
- NCT03011320
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- To assess tumor penetration of EC1456 in frozen tissue
History
Last registry update
Study completion
Primary completion
Started
Registered