Ovary CancerPhase 1NCT03011320
An Exploratory Study of the Folic Acid-tubulysin Conjugate EC1456 in Ovarian Cancer Subjects Undergoing Surgery
A Phase 1 study testing EC1456 and 99mTc-Etarfolatide in people with Ovary Cancer, run by Endocyte at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovary Cancer
- What is being tested?
- EC1456 and 99mTc-Etarfolatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Jan 2017to 28 Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must have the ability to understand, and have signed an approved informed consent form (ICF).
- Subjects must have cytologically or pathologically confirmed advanced ovarian cancer and be scheduled for primary, interval, or secondary, cytoreductive surgery as a part of standard of care for treatment of ovarian cancer, and have at least 1 lesion that can be removed at surgery.
- Subject must be ≥18 years of age.
- Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subjects with central nervous system (CNS) metastases must be neurologically stable and off of steroids for at least 14 days before pre-registration. Subjects with asymptomatic CNS metastatic disease without associated edema, shift, and a requirement for steroids or anti-seizure medications may be eligible after discussion with the sponsor's medical monitor.
- Subjects must have recovered (to baseline/ stabilization) from prior chemo- or radiotherapy and associated acute toxicities must have resolved to a NCI CTCAE v4 Grade 1 or less, with the exception of alopecia.
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- Subject must have adequate organ function:
- Bone marrow reserve:
- Absolute neutrophil count ≥1.5 × 109/L.
- Platelets ≥100 × 109/L.
- Hemoglobin ≥9 g/dL.
- Cardiac:
- Left ventricular ejection fraction (LVEF) ≥ the institutional lower limit of normal. LVEF must be evaluated within 28 days prior to the dose of EC1456.
- Cardiac Troponin I within normal limits.
- Electrocardiogram QT segment corrected by the method of Fridericia QTcFridericia (QTcF) < 450 msec on at least 2 of 3 screening ECG's. On site determination of QTcF may be used for screening purposes.
- Hepatic:
- Total bilirubin ≤1.5 × the upper limit of normal (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST
- 3.0 × ULN, or ≤5.0 × ULN for subjects with liver metastases.
- Renal: Serum creatinine ≤1.5 × ULN, or for subjects with serum creatinine >1.5 × ULN, creatinine clearance ≥50 mL/min.
- Subjects of childbearing potential:
- All women of childbearing potential MUST have a negative urine or serum pregnancy test within 1 week prior to the 99mTc-etarfolatide imaging procedure and within 1 week prior to the dose of EC1456.
- Women of childbearing potential must practice an effective method of birth control (e.g., oral, transdermal or injectable contraceptives, intrauterine device [IUD], or double-barrier contraception, such as diaphragm and spermicidal jelly) for the duration of their participation in
Who cannot join
- In the opinion of the investigator, a subject's physical condition might create a hardship for tolerating the radionuclide imaging procedures or a single administration of EC1456 (e.g., due to pain or dyspnea in prolonged supine positions).
- Use of the following medications within 6 months prior to EC1456 administration: amiodarone, disopyramide, dofetilide, dronedarone, flecanamide, ibutilide, quinidine, or sotalol.
- Subject has a co-morbid medical condition that, in the opinion of the investigator, is known to have a major impact on the pharmacokinetics (PK), distribution, metabolism, or elimination of either small molecule drug conjugate (SMDC).
- Subject has known active hepatitis B or hepatitis C.
- Subject has active uncontrolled infection(s).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Levine Cancer Institute-Concord/Clinical Trials
Concord, North Carolina, 28025
About this study
Official title: An Exploratory, Open-label Study of the Folic Acid-tubulysin Conjugate EC1456 in Ovarian Cancer Subjects Undergoing Cytoreductive 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. 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.
Read more
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.
Read the detailed description
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:
- < 8 hours preceding surgery or
- 48±4 hours preceding surgery.
At 2 time points:
- within approximately 15 (±5) minutes post-EC1456 administration and
- 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.
- Conditions
- Ovary Cancer
- Being tested
- EC1456, 99mTc-Etarfolatide
- Keywords
- ovarian cancer, specimen collection
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EC1456Drug
Also called folate (vitamin B-9) and tubulysin B hydrazide small molecule conjugate
intravenous (IV) bolus dose
99mTc-EtarfolatideDrug
Also called EC20, 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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 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 Receives: Drug: EC1456; Drug: 99mTc-Etarfolatide |
| Cohort 2 | Experimental | 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 Receives: Drug: EC1456; Drug: 99mTc-Etarfolatide |
| Cohort 3 | Experimental | 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 Receives: Drug: EC1456; Drug: 99mTc-Etarfolatide |
| Cohort 4 | Experimental | 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 Receives: Drug: EC1456; Drug: 99mTc-Etarfolatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess tumor penetration of EC1456 in frozen tissue
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.
Measured: 18 months
Secondary outcomes (2)
To assess tumor penetration EC1456 in formalin fixed tissue samples (intratumoral levels of EC1456 in tissue blocks using anti-tubulysin IHC testing)
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.
Measured: 18 months
To assess correlation of tumor penetration of EC1456 with tumor uptake of 99m-Tc etarfolatide in SPECT or SPECT/CT scan
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.
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start24 Jan 2017
- Primary completion30 Dec 2017
- Study completion28 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovary CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endocyte
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alison Armour, MB ChB, BSc, MSc, MD, MRCP, Study director, Endocyte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011320
- Sponsor's protocol ID
- EC1456-02
- Status last verified
- Feb 2019
- First submitted
- 19 Dec 2016
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Open-label Study of the Folic Acid-tubulysin Conjugate EC1456 in Ovarian Cancer Subjects Undergoing Cytoreductive Surgery
- ClinicalTrials.gov ID
- NCT03011320
- Acronym / sponsor ID
- EC1456-02
- Conditions
- Ovary Cancer
- Keywords
- ovarian cancer, specimen collection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- EndocyteIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- < 8 hours preceding surgery or
- 48±4 hours preceding surgery.
At 2 time points:
- within approximately 15 (±5) minutes post-EC1456 administration and
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: EC1456, Drug: 99mTc-EtarfolatideInjection 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 |
| Cohort 2 | Experimental | Drug: EC1456, Drug: 99mTc-EtarfolatideInjection 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 |
| Cohort 3 | Experimental | Drug: EC1456, Drug: 99mTc-EtarfolatideInjection 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 |
| Cohort 4 | Experimental | Drug: EC1456, Drug: 99mTc-EtarfolatideInjection 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Subject must have the ability to understand, and have signed an approved informed consent form (ICF).
- Subjects must have cytologically or pathologically confirmed advanced ovarian cancer and be scheduled for primary, interval, or secondary, cytoreductive surgery as a part of standard of care for treatment of ovarian cancer, and have at least 1 lesion that can be removed at surgery.
- Subject must be ≥18 years of age.
- Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subjects with central nervous system (CNS) metastases must be neurologically stable and off of steroids for at least 14 days before pre-registration. Subjects with asymptomatic CNS metastatic disease without associated edema, shift, and a requirement for steroids or anti-seizure medications may be eligible after discussion with the sponsor's medical monitor.
Key exclusion criteria (5 listed)
- In the opinion of the investigator, a subject's physical condition might create a hardship for tolerating the radionuclide imaging procedures or a single administration of EC1456 (e.g., due to pain or dyspnea in prolonged supine positions).
- Use of the following medications within 6 months prior to EC1456 administration: amiodarone, disopyramide, dofetilide, dronedarone, flecanamide, ibutilide, quinidine, or sotalol.
- Subject has a co-morbid medical condition that, in the opinion of the investigator, is known to have a major impact on the pharmacokinetics (PK), distribution, metabolism, or elimination of either small molecule drug conjugate (SMDC).
- Subject has known active hepatitis B or hepatitis C.
- Subject has active uncontrolled infection(s).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EC1456Also: folate (vitamin B-9) and tubulysin B hydrazide small molecule conjugateintravenous (IV) bolus dose | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| 99mTc-EtarfolatideAlso: EC20, etarfolatideInjection 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. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
To assess tumor penetration of EC1456 in frozen tissue
Time frame: 18 months
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.
2 secondary outcomes
To assess tumor penetration EC1456 in formalin fixed tissue samples (intratumoral levels of EC1456 in tissue blocks using anti-tubulysin IHC testing)
Time frame: 18 months
To assess correlation of tumor penetration of EC1456 with tumor uptake of 99m-Tc etarfolatide in SPECT or SPECT/CT scan
Time frame: 18 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Armour, MB ChB, BSc, MSc, MD, MRCP study director
Endocyte
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EC1456 and 99mTc-Etarfolatide in people with Ovary Cancer, run by Endocyte at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess tumor penetration of EC1456 in frozen tissue (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.