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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

Phase 1
18 Years
Not Enrolling
Solid Tumors, Advanced Solid Tumors

Thank you

Trial Information

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

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

- 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

- 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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of EP-100

Outcome Time Frame:


Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2009

Completion Date:

March 2012

Related Keywords:

  • Solid Tumors
  • Advanced Solid Tumors
  • Neoplasms



Mayo ClinicScottsdale, Arizona  
TGen Clinical Research Services at Scottsdale HealthcareScottsdale, Arizona  85258