Pharmacodynamics (PD) and Pharmacokinetics (PK) Study of EP-100 in Advanced Solid Tumors
Study Details
Study Description
Brief Summary
This study is being done to:
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Test the safety of EP-100 and see what effect (good and bad) it has on the patient and their cancer;
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Find the highest dose of EP-100 that can be given without causing bad side effects;
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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;
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Observe whether there is any effect of EP-100 on the size and activity of cancer in the patient's body.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Outcome Measures
Primary Outcome Measures
- To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of EP-100 [weekly]
- To establish the dose of EP-100 recommended for future phase II protocols [weekly]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects with histologically confirmed solid carcinomas
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Subjects whose tumors over express LHRH receptors in tumor biopsies
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Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy
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One or more metastatic tumors measurable on CT scan or evaluable disease
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Karnofsky performance ≥ 70%
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Life expectancy of at least 3 months
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Age greater than or equal to 18 years
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Signed, written informed consent. Consent must be provided prior to performing any study-related procedures.
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A negative pregnancy test (if female)
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Acceptable liver function
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Acceptable renal function
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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.
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Acceptable hematologic status:
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No clinically significant abnormalities
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Acceptable coagulation status:
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For men and women of child-producing potential, the use of effective contraceptive methods during the study
Exclusion Criteria:
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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
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Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
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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.
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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).
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Subjects with active CNS metastases are excluded.
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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.
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Had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1
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Had minor surgery within 2 weeks prior to Day 1
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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.
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Patients who have potentially life-threatening disease (hypercalcemia, spinal cord compression) whose disease may acutely progress if EP-100 administration causes a flare reaction.
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Unwillingness or inability to comply with procedures required in this protocol
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Known infection with HIV, hepatitis B, or hepatitis C
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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).
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Patients under chronic treatment with corticosteroids.
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Baseline QTc exceeding 450 msec (using the Bazetts formula) and/or patients receiving class 1A or class III antiarrythmic agents.
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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
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Subjects who are currently receiving any other investigational agent
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | TGEN Clinical Research Services at Scottsdale Healthcare | Scottsdale | Arizona | United States | 85258 |
| 2 | Mayo Clinic | Scottsdale | Arizona | United States | 85259 |
Sponsors and Collaborators
- Esperance Pharmaceuticals Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ESP2009-001