Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-25 @ 6:15 PM
Study NCT ID:
NCT00949559
Status:
COMPLETED
Last Update Posted:
2012-04-04
First Post:
2009-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacodynamics (PD) and Pharmacokinetics (PK) Study of EP-100 in Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718007', 'term': 'EP-100 membrane-disrupting peptide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-03', 'studyFirstSubmitDate': '2009-07-29', 'studyFirstSubmitQcDate': '2009-07-29', 'lastUpdatePostDateStruct': {'date': '2012-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of EP-100', 'timeFrame': 'weekly'}, {'measure': 'To establish the dose of EP-100 recommended for future phase II protocols', 'timeFrame': 'weekly'}]}, 'conditionsModule': {'conditions': ['Solid Tumors', 'Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': "This study is being done to:\n\n* Test the safety of EP-100 and see what effect (good and bad) it has on the patient and their cancer;\n* Find the highest dose of EP-100 that can be given without causing bad side effects;\n* 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;\n* Observe whether there is any effect of EP-100 on the size and activity of cancer in the patient's body."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with histologically confirmed solid carcinomas\n* Subjects whose tumors over express LHRH receptors in tumor biopsies\n* Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy\n* One or more metastatic tumors measurable on CT scan or evaluable disease\n* Karnofsky performance ≥ 70%\n* Life expectancy of at least 3 months\n* Age greater than or equal to 18 years\n* Signed, written informed consent. Consent must be provided prior to performing any study-related procedures.\n* A negative pregnancy test (if female)\n* Acceptable liver function\n* Acceptable renal function\n* 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.\n* Acceptable hematologic status:\n* No clinically significant abnormalities\n* Acceptable coagulation status:\n* For men and women of child-producing potential, the use of effective contraceptive methods during the study\n\nExclusion Criteria:\n\n* 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\n* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy\n* 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.\n* 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).\n* Subjects with active CNS metastases are excluded.\n* 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.\n* Had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1\n* Had minor surgery within 2 weeks prior to Day 1\n* 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.\n* Patients who have potentially life-threatening disease (hypercalcemia, spinal cord compression) whose disease may acutely progress if EP-100 administration causes a flare reaction.\n* Unwillingness or inability to comply with procedures required in this protocol\n* Known infection with HIV, hepatitis B, or hepatitis C\n* 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).\n* Patients under chronic treatment with corticosteroids.\n* Baseline QTc exceeding 450 msec (using the Bazetts formula) and/or patients receiving class 1A or class III antiarrythmic agents.\n* 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\n* Subjects who are currently receiving any other investigational agent\n* 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.'}, 'identificationModule': {'nctId': 'NCT00949559', 'briefTitle': 'Pharmacodynamics (PD) and Pharmacokinetics (PK) Study of EP-100 in Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Esperance Pharmaceuticals Inc'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ESP2009-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'EP-100', 'type': 'DRUG', 'description': 'as a single agent administered intravenously twice weekly x 3 with 1 week off (total 28 days)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'TGEN Clinical Research Services at Scottsdale Healthcare', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Esperance Pharmaceuticals Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}