Recurrent or Metastatic CancerPhase 2NCT01684098
Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor
A Phase 2 study testing Tc 99m EC20 in people with Recurrent or Metastatic Cancer and Head and Neck Cancer, run by Endocyte.
Trial summary
The folate receptor is over-expressed on many types of cancer cells and new folate receptor targeted therapies are being developed to target cancer cells that over-express the folate receptor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent or Metastatic Cancer, Head and Neck Cancer, Pancreas Cancer
- What is being tested?
- Tc 99m EC20
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to Aug 2005
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet the following eligibility requirements to be enrolled in the study:
- Patient must be 18 years of age or older.
- Patient must have known or strongly suspected recurrent or metastatic cancer from a solid tumor with at least one identifiable lesion > 1.5 cm as diagnosed by conventional imaging.
- Patient must have adequate kidney function defined as serum creatinine of < 1.5 X ULN.
- Patient must have adequate liver function defined as transaminases (SGOT and/or SGPT) may be up to 2.5 X ULN if alkaline phosphatase is <ULN or alkaline phosphatase may be up to 2.5 X ULN if Transaminases are < ULN. If alkaline phosphatase is outside of these parameters and is due to bone metastases verified by assessment of isoenzymes, then the subject is eligible.
- Patient must provide written informed consent prior to enrollment.
Who cannot join
- Patients must be excluded in any of the following conditions are present:
- Patient is pregnant or breastfeeding.
- Patient is simultaneously participating in another investigational drug study, excluding the follow-up phase.
- Patient has received an investigational agent within 7 days prior to enrollment.
- Patient is unable to tolerate conditions for radionuclide imaging.
- Patient has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.
About this study
Official title: A Phase II Clinical Study to Evaluate the Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor
The folate receptor is over-expressed on many types of cancer cells and new folate receptor targeted therapies are being developed to target cancer cells that over-express the folate receptor. As with other targeted therapies, it is important to develop diagnostic tests that will provide accurate information on folate receptor status and aid in selecting patients that may benefit from folate-targeted therapy.
Read the detailed description
This Phase II, limited institution, open-label, single-arm, baseline-controlled study is designed to obtain data on the percentage of patients with recurrent or metastatic cancer from a solid tumor (including, but not limited to, breast, lung, mesothelioma, liver, colorectal, prostate, head and neck, pancreas, bladder and testicular cancer) with increased uptake of FalateScan in tumors, correlate the immunohistochemical staining findings with the FolateScan images, and verify product safety in patients with suspected recurrent or metastatic disease from any solid tumor.
- Conditions
- Recurrent or Metastatic Cancer, Head and Neck Cancer, Pancreas Cancer, Bladder Cancer, Testicular Cancer
- Being tested
- Tc 99m EC20
- Keywords
- recurrent or metastatic cancer, head and neck cancer, pancreas cancer, bladder cancer, testicular cancer
- Medical subject headings
- Recurrence, Neoplasm Metastasis, Head and Neck Neoplasms, Pancreatic Neoplasms, Urinary Bladder Neoplasms, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tc 99m EC20Drug
| Study group | Role | What they receive |
|---|---|---|
| Tc 99m EC20 | Other | Not described Receives: Drug: Tc 99m EC20 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startAug 2003
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Endocyte
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nelson M Oyesiku, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684098
- Sponsor's protocol ID
- EC20.8
- Status last verified
- Sep 2012
- First submitted
- 9 Sep 2012
- Last updated
- 22 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor
- ClinicalTrials.gov ID
- NCT01684098
- Acronym / sponsor ID
- EC20.8
- Conditions
- Recurrent or Metastatic Cancer, Head and Neck Cancer, Pancreas Cancer, Bladder Cancer, Testicular Cancer
- Keywords
- recurrent or metastatic cancer, head and neck cancer, pancreas cancer, bladder cancer, testicular cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- EndocyteIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Study completion
- Aug 2005
- First posted
- 12 Sep 2012 (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.
The folate receptor is over-expressed on many types of cancer cells and new folate receptor targeted therapies are being developed to target cancer cells that over-express the folate receptor. As with other targeted therapies, it is important to develop diagnostic tests that will provide accurate information on folate receptor status and aid in selecting patients that may benefit from folate-targeted therapy.
Detailed description
This Phase II, limited institution, open-label, single-arm, baseline-controlled study is designed to obtain data on the percentage of patients with recurrent or metastatic cancer from a solid tumor (including, but not limited to, breast, lung, mesothelioma, liver, colorectal, prostate, head and neck, pancreas, bladder and testicular cancer) with increased uptake of FalateScan in tumors, correlate the immunohistochemical staining findings with the FolateScan images, and verify product safety in patients with suspected recurrent or metastatic disease from any solid tumor.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tc 99m EC20 | Other | Drug: Tc 99m EC20 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must meet the following eligibility requirements to be enrolled in the study:
Key exclusion criteria (6 listed)
- Patients must be excluded in any of the following conditions are present:
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 |
|---|---|---|
| Tc 99m EC20 | Drug | Tc 99m EC20 |
Primary outcome
Not reported in the source record.
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 22 Jun 2023.
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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.
Nelson M Oyesiku, MD, PhD principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tc 99m EC20 in people with Recurrent or Metastatic Cancer and Head and Neck Cancer, run by Endocyte.
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 6 inclusion and 6 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 22 Jun 2023.