Advanced CancerPhase 1NCT00423410
A Safety Study of EPC2407, A Anti-Cancer Drug With Vascular Disrupting Activity: In Patients With Advanced Cancer
A Phase 1 study testing EPC2407 (crinobulin) in people with Advanced Cancer, run by EpiCept Corporation at 3 sites in United States.
Trial summary
This study will evaluate the safety, pharmacokinetics (PK), and pharmacodynamic effects of a novel anti-cancer drug, EPC2407, administered to patients with advanced cancer which have not responded to or have recurred following treatment with available therapies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- EPC2407 (crinobulin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2006to Sep 2009
- 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
- Histologically or cytologically confirmed solid tumor or lymphoma,which has progressed on standard therapies, for which effective therapy is not available or for patients who are unwilling to undergo such therapies.
- Males and Females at least 18 years of age
- Laboratory data as specified below (according to the site's clinical laboratory ranges for normal):
- Hematology: ANC >1500 cells/mm3, platelet count >100,000 cells/mm3 and Hemoglobin > 9 gm/L ii. Hepatic: Direct bilirubin <1.5 X ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 X ULN. For patients with known liver metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5.0 X ULN iii. Renal: serum creatinine WNL or creatinine clearance >60 mL/min
- 12-lead electrocardiogram (ECG) QT intervals: QTc ≤ 450 msec for men and ≤ 470 msec for women.
- Estimated life expectancy of at least 3 months
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- ECOG Performance Status < or = 1
- Previously treated CNS disease allowed if treatment completed and stable for 4 weeks.
- For men and women of child-producing potential - willingness to employ appropriate contraceptive methods (including abstinence) during the study
- Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments
- Cardiac ejection fraction ≥50% by 2D Echocardiogram or > institutional lower limits of normal
Who cannot join
- Women who are pregnant or nursing
- Radiotherapy or any chemotherapy within the previous 21 days or five half lives of prior drug (whichever is shorter). See also exclusion #4 below for patients at risk for cardiac toxicity. Recovery to Grade 1 or less from chemotherapy-induced toxic effect, except alopecia, is required.
- Major surgery within the last 4 weeks or minor surgery within the last 2 weeks
- Significant risk of cardiac drug toxicity due to any of the following: a) Active New York Heart Association Class III or IV, b) history of or current congestive heart failure, c) history of myocardial infarction within the last 6 months or ongoing unstable angina, or anthracycline exposure per exclusion #5.
- Anthracycline exposure exceeding a cumulative dose of 360 mg/m²
- Known and ongoing HIV, Hepatitis B or Hepatitis C infection
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- Concomitant use of strong inhibitors of the liver microsomal enzymes CYP2C8, CYP2C9, CYP2C19 and CYP3A4.
- Participation in concurrent study of an investigational agent or device
- Any other condition including but not limited to major co-morbidities, which in the opinion of the investigator would render the patient ineligible
- O2 Saturation by pulse oximetry at rest < 90%
- Concomitant use of drugs that have significant risk of Torsades de Pointes will also be prohibited. Please refer to drugs listed under "Drugs with Risk of Torsades de Pointes"
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tower Oncology Research
Beverly Hills, California, 90211
Rebecca and John Moores UCSD Cancer Center
San Diego, California, 92093
Scottsdale Healthcare
Scottsdale, Arizona, 85258
About this study
Official title: A First In Man Phase I Study Of EPC2407, A Microtubule Inhibitor Anti-Cancer Drug With Tumor Vascular Endothelial Disrupting Activity: Intravenous Administration Daily For Three Days In Patients With Advanced Solid Tumors And Lymphomas
This study will evaluate the safety, pharmacokinetics (PK), and pharmacodynamic effects of a novel anti-cancer drug, EPC2407, administered to patients with advanced cancer which have not responded to or have recurred following treatment with available therapies
Read the detailed description
This is a Phase I, open label, multicenter, dose-escalation, safety, pharmacokinetic, and pharmacodynamic study of EPC2407 administered intravenously over 60 minutes on a QDx3 schedule repeated every 21 days. Patients are enrolled and dosed at the level defined by the escalation scheme. The primary goal of the study design is to assess toxicity at the fixed dose levels according to the modified Fibonacci schema.
- Conditions
- Advanced Cancer
- Being tested
- EPC2407 (crinobulin)
- Keywords
- Cancer, Tumor, Lymphoma
- Medical subject headings
- Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPC2407 (crinobulin)Drug
IV infusion 1 to 4 hours
| Study group | Role | What they receive |
|---|---|---|
| EPC2407 (crinobulin) | Experimental | Not described Receives: Drug: EPC2407 (crinobulin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: Duration of drug exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startDec 2006
- Primary completionApr 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EpiCept Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423410
- Sponsor's protocol ID
- EPC2006-04
- Status last verified
- Sep 2009
- First submitted
- 16 Jan 2007
- Last updated
- 10 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First In Man Phase I Study Of EPC2407, A Microtubule Inhibitor Anti-Cancer Drug With Tumor Vascular Endothelial Disrupting Activity: Intravenous Administration Daily For Three Days In Patients With Advanced Solid Tumors And Lymphomas
- ClinicalTrials.gov ID
- NCT00423410
- Acronym / sponsor ID
- EPC2006-04
- Conditions
- Advanced Cancer
- Keywords
- Cancer, Tumor, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- EpiCept CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 18 Jan 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 study will evaluate the safety, pharmacokinetics (PK), and pharmacodynamic effects of a novel anti-cancer drug, EPC2407, administered to patients with advanced cancer which have not responded to or have recurred following treatment with available therapies
Detailed description
This is a Phase I, open label, multicenter, dose-escalation, safety, pharmacokinetic, and pharmacodynamic study of EPC2407 administered intravenously over 60 minutes on a QDx3 schedule repeated every 21 days. Patients are enrolled and dosed at the level defined by the escalation scheme. The primary goal of the study design is to assess toxicity at the fixed dose levels according to the modified Fibonacci schema.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EPC2407 (crinobulin) | Experimental | Drug: EPC2407 (crinobulin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically confirmed solid tumor or lymphoma,which has progressed on standard therapies, for which effective therapy is not available or for patients who are unwilling to undergo such therapies.
- Males and Females at least 18 years of age
- Laboratory data as specified below (according to the site's clinical laboratory ranges for normal):
- 12-lead electrocardiogram (ECG) QT intervals: QTc ≤ 450 msec for men and ≤ 470 msec for women.
- Estimated life expectancy of at least 3 months
Key exclusion criteria (11 listed)
- Women who are pregnant or nursing
- Radiotherapy or any chemotherapy within the previous 21 days or five half lives of prior drug (whichever is shorter). See also exclusion #4 below for patients at risk for cardiac toxicity. Recovery to Grade 1 or less from chemotherapy-induced toxic effect, except alopecia, is required.
- Major surgery within the last 4 weeks or minor surgery within the last 2 weeks
- Significant risk of cardiac drug toxicity due to any of the following: a) Active New York Heart Association Class III or IV, b) history of or current congestive heart failure, c) history of myocardial infarction within the last 6 months or ongoing unstable angina, or anthracycline exposure per exclusion #5.
- Anthracycline exposure exceeding a cumulative dose of 360 mg/m²
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 |
|---|---|---|
| EPC2407 (crinobulin)IV infusion 1 to 4 hours | Drug | EPC2407 (crinobulin) |
Primary outcome
Safety
Time frame: Duration of drug exposure
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 10 Sep 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 EPC2407 (crinobulin) in people with Advanced Cancer, run by EpiCept Corporation 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 11 inclusion and 11 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 10 Sep 2009. 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?
Safety (time frame: Duration of drug exposure). 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 10 Sep 2009.