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

NCT00949559 | Completed Phase 1

• 1 other identifier: ESP2009-001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Solid Tumors; Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

EP-100 DRUG

as a single agent administered intravenously twice weekly x 3 with 1 week off (total 28 days)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Esperance Pharmaceuticals Inc: lead

Study Sites (2)

TGEN Clinical Research Services at Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

Location

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Interventions

EP-100 membrane-disrupting peptide

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2009
• First Posted: July 30, 2009
• Study Start: July 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 4, 2012

Record last verified: 2012-04

Locations

US (2)