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An Exploratory Study of the Folic Acid-tubulysin Conjugate EC1456 in Ovarian Cancer Subjects Undergoing Surgery

NCT03011320 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-02-07

No results posted yet for this 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.

Conditions

  • Ovary Cancer

Interventions

DRUG

EC1456

intravenous (IV) bolus dose

DRUG

99mTc-Etarfolatide

Injection of unlabeled etarfolatide followed by etarfolatide labeled with 740 to 925 megabecquerels (MBq) \[20 to 25 millicuries (mCi)\] of sodium pertechnetate Tc-99m injection, followed by a single-photon emission tomography (SPECT) or single-photon emission tomography with in-line x-ray computed tomography (SPECT/CT) scan.

Sponsors & Collaborators

  • Endocyte

    lead INDUSTRY

Principal Investigators

  • Alison Armour, MB ChB, BSc, MSc, MD, MRCP · Endocyte

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-24
Primary Completion
2017-12-30
Completion
2018-08-28
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03011320 on ClinicalTrials.gov