Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Micronutrients

Hematinics

All Drugs and Chemicals

Vitamins

Folic Acid

Vitamin B Complex

Sodium Pertechnetate Tc 99m

Folinic Acid

Folate

Vitamin B9

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.

One dose of 4 mg/m2 EC1456 at \<8 hours prior to surgery

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.

One dose of 4 mg/m2 EC1456 at 48±4 hours prior to surgery

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.

One dose of 8 mg/m2 EC1456 at \<8 hours prior to surgery

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.

One dose of 8 mg/m2 EC1456 at 48±4 hours prior to surgery

EC1456

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.

99mTc-Etarfolatide

Alison Armour, MB ChB, BSc, MSc, MD, MRCP

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.

Study EC1456-02 is an exploratory, open-label study that seeks to enroll subjects with ovarian cancer who will be undergoing therapeutic debulking surgery.

All subjects will undergo a 99mTc-etarfolatide scan within 2 weeks prior to EC1456 administration. Briefly, prior to the 99mTc-etarfolatide imaging procedure, all subjects will receive one intravenous (IV) injection of folic acid or unlabeled etarfolatide, followed within 1 to 3 minutes by an injection of 99m Tc-etarfolatide (i.e., etarfolatide labeled with 740 to 925 megabecquerels (MBq) \[20 to 25 millicuries (mCi)\] of sodium pertechnetate Tc-99m injection).

Individual subjects will receive 1 of the following 2 doses of EC1456 pre-operatively:

* 4 milligrams (mg)/meter (m)2
* 8 milligrams (mg)/meter (m)2

EC1456 will be administered at 1 of the following 2 time points:

* \<8 hours before planned surgery
* 48±4 hours before planned surgery

The 4 mg/m2 dose of EC1456 administered \<8 hours prior to surgery will be the first dose cohort to enroll. Once enrollment to this cohort is complete, the remaining cohorts will be open for enrollment. Assignment to specific cohorts will be determined by the Sponsor based on data assessed from previously enrolled subjects. Two to six subjects will be enrolled per cohort as shown below.

* Cohort 1: 4 mg/m2 EC1456 \<8 hours prior to surgery
* Cohort 2: 4 mg/m2 EC1456 48±4 hours prior to surgery
* Cohort 3: 8 mg/m2 EC1456 \<8 hours prior to surgery
* Cohort 4: 8 mg/m2 EC1456 48±4 hours prior to surgery

In the event of unexpected results, lower, intermediate or higher EC1456 levels up to 12.5 mg/m2, the highest determined safe dose of EC1456 as defined by the parallel phase I study EC1456-01, may be explored.

The first on-study procedure will be SPECT or SPECT/CT with 99mTc-etarfolatide. SPECT or SPECT/CT scans will be acquired within 2 weeks prior to EC1456 administration as specified in the Imaging Operations Manual.

EC1456 will be administered pre-operatively as an intravenous (IV) bolus infusion at 1 of 2 time points:

1. \< 8 hours preceding surgery or
2. 48±4 hours preceding surgery.

At 2 time points:

1. within approximately 15 (±5) minutes post-EC1456 administration and
2. at the start of surgery, approximately 5 mL of whole blood will be drawn for EC1456 analyses.

Tissues to be collected at surgery, if present, include: sample of 1 or both ovaries, endometrium, omentum, ascitic fluid and/or selected lesions as identified by the surgeon or sponsor. The location of each sample will be annotated such that the ex vivo analysis may be correlated with the SPECT/CT image post-surgery. Samples of tumor tissue will be collected at the time of surgery, aliquoted into collection vials, and placed on dry ice or in buffered formalin.

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

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.

Measurement and characterization of intratumoral levels of EC1456 in the tissue blocks and assess if there is detectable penetration of the drug into the tumor using anti-tubulysin immunohistochemistry (IHC) testing. All results will be descriptive and exploratory.

Using the measures of tumor penetration, see if the SPECT or SPECT/CT scan correlates with etarfolatide update in the 99m-TC etarfolatide SPECT or SPECT/CT scans. All results will be descriptive and exploratory.

Endocyte

Spots Global Cancer Trial Database for ec1456

Every month we try and update this database with for ec1456 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ec1456

Every month we try and update this database with for ec1456 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ec1456 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.