Clinical Trials

Pharmacodynamics (PD) and Pharmacokinetics (PK) Study of EP-100 in Advanced Solid Tumors

Location:

Trial status:

Closed

Why is this study being done?

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.

Who is eligible to participate?

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.

Last updated: 04/03/2012

NCT ID:

NCT00949559