- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00949559
Pharmacodynamics (PD) and Pharmacokinetics (PK) Study of EP-100 in Advanced Solid Tumors
April 3, 2012 updated by: Esperance Pharmaceuticals Inc
A Phase 1, Multi-center, Open-label, Dose-escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of EP-100 Given Intravenously 3 Out of 4 Weeks in Subjects With Advanced Solid Tumors
This study is being done to:
- Test the safety of EP-100 and see what effect (good and bad) it has on the patient and their cancer;
- Find the highest dose of EP-100 that can be given without causing bad side effects;
- Examine how much EP-100 is in the blood at certain times after it is given and how quickly the body gets rid of it;
- Observe whether there is any effect of EP-100 on the size and activity of cancer in the patient's body.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85259
- Mayo Clinic
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Scottsdale, Arizona, United States, 85258
- TGen Clinical Research Services at Scottsdale Healthcare
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects with histologically confirmed solid carcinomas
- Subjects whose tumors over express LHRH receptors in tumor biopsies
- Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy
- One or more metastatic tumors measurable on CT scan or evaluable disease
- Karnofsky performance ≥ 70%
- Life expectancy of at least 3 months
- Age greater than or equal to 18 years
- Signed, written informed consent. Consent must be provided prior to performing any study-related procedures.
- A negative pregnancy test (if female)
- Acceptable liver function
- Acceptable renal function
- Serum creatinine within normal limits, OR calculated creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
- Acceptable hematologic status:
- No clinically significant abnormalities
- Acceptable coagulation status:
- For men and women of child-producing potential, the use of effective contraceptive methods during the study
Exclusion Criteria:
- New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- Pregnant or nursing women. NOTE: Women of child bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Treatment with radiation therapy or investigational therapy within 4 weeks prior to Day 1. Had received chemotherapy prior to study entry equivalent within 3 to 5 half-lives of that chemotherapy agent or 4 weeks prior to study entry (whichever is shorter) with resolution of any side effects from that previous therapy (6 weeks for nitrosoureas or Mitomycin C).
- Subjects with active CNS metastases are excluded.
- Subjects with a history of CNS metastases will be eligible if they have been treated and are stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be off steroids.
- Had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1
- Had minor surgery within 2 weeks prior to Day 1
- Patients who may benefit from hormonal treatment such as breast cancer patients whose tumors are hormone receptor positive (ER/PR) and without rapidly progressive visceral disease or patients with prostate cancer who have not had hormonal manipulation therapy.
- Patients who have potentially life-threatening disease (hypercalcemia, spinal cord compression) whose disease may acutely progress if EP-100 administration causes a flare reaction.
- Unwillingness or inability to comply with procedures required in this protocol
- Known infection with HIV, hepatitis B, or hepatitis C
- Subjects who are susceptible to histamine release (e.g. patients with mastocytosis, mastocytoma, mast cell leukemia, asthma, hay fever, and other allergic disorders and disorders that increase mast cell numbers).
- Patients under chronic treatment with corticosteroids.
- Baseline QTc exceeding 450 msec (using the Bazetts formula) and/or patients receiving class 1A or class III antiarrythmic agents.
- Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
- Subjects who are currently receiving any other investigational agent
- Subjects should not be using any LHRH agonists (such as leuprolide [Lupron, Eligard], buserelin [Suprefact, Suprecor], nafarelin [Synarel], histrelin [Supprelin], goserelin [Zoladex], deslorelin [Suprelorin, Ovuplant], Triptorelin and others) or antagonists (such as Abarelix [Plenaxis], Cetrorelix [Cetrotide], Ganirelix [Antagon] and others) prior to study treatments. If LHRH agonists are being used, a 4-week washout period is recommended.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of EP-100
Time Frame: weekly
|
weekly
|
To establish the dose of EP-100 recommended for future phase II protocols
Time Frame: weekly
|
weekly
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
July 29, 2009
First Submitted That Met QC Criteria
July 29, 2009
First Posted (Estimate)
July 30, 2009
Study Record Updates
Last Update Posted (Estimate)
April 4, 2012
Last Update Submitted That Met QC Criteria
April 3, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESP2009-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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