CancerPhase 1NCT00441870
Study of EC0225 for the Treatment of Refractory or Metastatic Tumors
A Phase 1 study testing EC0225, for Injection (Folic acid desacetylvinblastine hydrazide conjugate) and 99mTC-EC20 (Folic acid-technetium 99m conjugate) in people with Cancer, run by Endocyte at 3 sites in United States.
Trial summary
This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0225 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- EC0225, for Injection (Folic acid desacetylvinblastine hydrazide conjugate) and 99mTC-EC20 (Folic acid-technetium 99m conjugate)
- Type of treatment
- Injection or infusion
- How many people
- 77 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2007to Nov 2010
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Histological or cytological diagnosis of neoplasm
- No effective standard therapeutic options
- ECOG performance status of 0-2
- ≥ to 4 weeks post therapeutic radiation or chemotherapy(≥ to 6 weeks for nitrosureas) and recovery (to baseline status) from associated acute toxicities. Patients previously treated with non-cytotoxic therapy and who have recovered from or have controlled drug-associated toxicity are allowed to enter the trial after a period consisting of 4 half-lives of the agent.
- Negative serum pregnancy test for women of child-bearing potential within one week prior to treatment with investigational agents (99mTc-EC20 and EC0225)
- Adequate bone marrow reserve, renal and hepatic function
Who cannot join
- Concurrent malignancies
- Women who are pregnant or lactating
- Evidence of symptomatic brain metastases
- Receiving concomitant anticancer therapy (excluding supportive care)
- Requires palliative radiotherapy at time of study entry
- Unable to tolerate conditions for radionuclide imaging
- Administration of another radiopharmaceutical that would interfere with assessment of 99mTc-EC20
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Greenebaum Cancer Center - University of Maryland Medicine
Baltimore, Maryland, 21201
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Nevada Cancer Institute
Las Vegas, Nevada, 89135
About this study
Official title: Protocol EC-0225-01: A Phase 1 Study of EC0225 Administered Weeks 1 and 3 of a 4-Week Cycle
This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0225 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.
Read the detailed description
This is a Phase 1, dose escalation study of EC0225 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0225 is a drug that is specifically designed to enter cells via a folate vitamin receptor. Experimental evidence shows that the target receptor is over-expressed in many human cancers. There are no previous human studies of EC0225; however, lab research (research in test tubes or animals) using EC0225 has shown activity against tumors in animals. This activity in animal models suggests that EC0225 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0225 given by intravenous bolus. The efficacy of treatment will also be measured.
- Conditions
- Cancer
- Being tested
- EC0225, for Injection (Folic acid desacetylvinblastine hydrazide conjugate), 99mTC-EC20 (Folic acid-technetium 99m conjugate)
- Keywords
- Cancer, Phase 1, EC0225, EC20, Refractory, Metastatic, Experimental
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EC0225, for Injection (Folic acid desacetylvinblastine hydrazide conjugate)Drug
Also called Folic acid desacetylvinblastine hydrazide conjugate
Dose escalation from a starting dose of 0.38mg IV bolus Monday Wednesday and Friday Weeks 1 and 3 of a 4 Week Cycle to the Maximum Tolerated Dose (MTD)
99mTC-EC20 (Folic acid-technetium 99m conjugate)Drug
Also called Folic acid-technetium 99m conjugate, FolateScan
20-25 mCi 99m Tc-EC20 administered IV 1-2 hours prior to imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Measured: Dose escalation to the highest dose that can be safely administered to produce acceptable, manageable and reversible toxicity in no more than 0 or 1 of 6 patients
Secondary outcomes (4)
Pharmacokinetic and pharmacodynamic parameters
Measured: Obtained during the first cycle of therapy on Days 1 and 3
Anti-tumor activity
Measured: Initial dose of study therapy to disease progression
Uptake of 99mTc-Ec20 in tumors and normal tissues
Measured: 1-2 hours post-administration of 99mTc-EC20
Safety and tolerability
Measured: Initiation of study therapy through 30 day post last dose of study therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endocyte
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard A. Messmann, MD, MHS, MSc, Study director, Endocyte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441870
- Sponsor's protocol ID
- EC-0225-01
- Status last verified
- Mar 2012
- First submitted
- 27 Feb 2007
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol EC-0225-01: A Phase 1 Study of EC0225 Administered Weeks 1 and 3 of a 4-Week Cycle
- ClinicalTrials.gov ID
- NCT00441870
- Acronym / sponsor ID
- EC-0225-01
- Conditions
- Cancer
- Keywords
- Cancer, Phase 1, EC0225, EC20, Refractory, Metastatic, Experimental
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- EndocyteIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 1 Mar 2007 (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 is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0225 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.
Detailed description
This is a Phase 1, dose escalation study of EC0225 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0225 is a drug that is specifically designed to enter cells via a folate vitamin receptor. Experimental evidence shows that the target receptor is over-expressed in many human cancers. There are no previous human studies of EC0225; however, lab research (research in test tubes or animals) using EC0225 has shown activity against tumors in animals. This activity in animal models suggests that EC0225 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0225 given by intravenous bolus. The efficacy of treatment will also be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older
- Histological or cytological diagnosis of neoplasm
- No effective standard therapeutic options
- ECOG performance status of 0-2
- ≥ to 4 weeks post therapeutic radiation or chemotherapy(≥ to 6 weeks for nitrosureas) and recovery (to baseline status) from associated acute toxicities. Patients previously treated with non-cytotoxic therapy and who have recovered from or have controlled drug-associated toxicity are allowed to enter the trial after a period consisting of 4 half-lives of the agent.
Key exclusion criteria (7 listed)
- Concurrent malignancies
- Women who are pregnant or lactating
- Evidence of symptomatic brain metastases
- Receiving concomitant anticancer therapy (excluding supportive care)
- Requires palliative radiotherapy at time of study entry
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 |
|---|---|---|
| EC0225, for Injection (Folic acid desacetylvinblastine hydrazide conjugate)Also: Folic acid desacetylvinblastine hydrazide conjugateDose escalation from a starting dose of 0.38mg IV bolus Monday Wednesday and Friday Weeks 1 and 3 of a 4 Week Cycle to the Maximum Tolerated Dose (MTD) | Drug | – |
| 99mTC-EC20 (Folic acid-technetium 99m conjugate)Also: Folic acid-technetium 99m conjugate, FolateScan20-25 mCi 99m Tc-EC20 administered IV 1-2 hours prior to imaging | Drug | – |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Dose escalation to the highest dose that can be safely administered to produce acceptable, manageable and reversible toxicity in no more than 0 or 1 of 6 patients
4 secondary outcomes
Pharmacokinetic and pharmacodynamic parameters
Time frame: Obtained during the first cycle of therapy on Days 1 and 3
Anti-tumor activity
Time frame: Initial dose of study therapy to disease progression
Uptake of 99mTc-Ec20 in tumors and normal tissues
Time frame: 1-2 hours post-administration of 99mTc-EC20
Safety and tolerability
Time frame: Initiation of study therapy through 30 day post last dose of study therapy
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 9 Mar 2012.
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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.
Richard A. Messmann, MD, MHS, MSc study director
Endocyte
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EC0225, for Injection (Folic acid desacetylvinblastine hydrazide conjugate) and 99mTC-EC20 (Folic acid-technetium 99m conjugate) in people with Cancer, run by Endocyte at 3 sites in United States.
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 7 inclusion and 7 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 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Maximum tolerated dose (MTD) (time frame: Dose escalation to the highest dose that can be safely administered to produce acceptable, manageable and reversible toxicity in no more than 0 or 1 of 6 patients). 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 9 Mar 2012.