Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT00034151
Status:
COMPLETED
Last Update Posted:
2009-06-04
First Post:
2002-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-02', 'studyFirstSubmitDate': '2002-04-23', 'studyFirstSubmitQcDate': '2002-04-23', 'lastUpdatePostDateStruct': {'date': '2009-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the objective and partial response rates', 'timeFrame': 'No time frame-based on number of patients'}], 'secondaryOutcomes': [{'measure': 'Time to progression, duration of response and duration of survival', 'timeFrame': 'Based on number of patients'}]}, 'conditionsModule': {'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients with stage III or IV platinum resistant ovarian cancer or primary peritoneal carcinoma.', 'detailedDescription': 'The goals of this study are to determine the objective response rate, to determine time to disease progression, duration of response, and survival, and to identify the maximum tolerated weekly dose and principal toxicities of S-8184 in this patient population.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHistologic diagnosis of ovarian cancer or primary peritoneal carcinoma\n\nStage III or IV disease\n\nOne and only one prior cytotoxic chemotherapy regimen which must have included a platinum agent\n\nPlatinum resistant disease, defined as documented progression within six months of completion of first line therapy\n\nAdult (18 years of age or older) patients\n\nAdequate hematologic function (ANC greater than 1500 cells/mm3 and platelets greater than 100,000/mm3)\n\nSerum creatinine less than 2.0 mg/dL\n\nTotal bilirubin less than 1.5 mg/dL; SGOT and SGPT less than 3 times the upper limit of institutional normal values\n\nECOG performance status of 0 - 2\n\nBidimensional measurable or clinically evaluable disease\n\nPatients who have signed an IRB / Ethics Committee approved informed consent\n\nLife expectancy at least 12 weeks\n\nPatient has fully recovered from any previous surgery (at least 4 weeks since major surgery)\n\nPatient has a negative pregnancy test prior to study entry if premenopausal. (Patients of child bearing potential must use a medically effective form of contraception during the treatment.)\n\nExclusion Criteria:\n\nPatients who have received any taxane-containing preparation including Taxol (paclitaxel) or Taxotere (docetaxel)\n\nFemales who are pregnant or lactating\n\nPatients with peripheral neuropathy NCI-CTC grade 2 or greater\n\nPatients who have received wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of study entry; or mitomycin or nitrosoureas within 6 weeks of study entry\n\nPatients who have had an investigational agent within 4 weeks of study entry\n\nPatients receiving concurrent anticonvulsants known to induce P450 isoenzymes'}, 'identificationModule': {'nctId': 'NCT00034151', 'briefTitle': 'Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Achieve Life Sciences'}, 'officialTitle': 'A Phase IIA Evaluation of Safety and Efficacy of Weekly S-8184 Paclitaxel Injectable Emulsion in Second Line Treatment of Stage III or IV Platinum Resistant Ovarian Cancer or Primary Peritoneal Carcinoma', 'orgStudyIdInfo': {'id': 'SON-8184-1061'}}, 'armsInterventionsModule': {'interventions': [{'name': 'S-8184 Paclitaxel Injectable Emulsion', 'type': 'DRUG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Achieve Life Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Monica Krieger, VP Regulatory Affairs', 'oldOrganization': 'OncoGenex Pharmaceuticals'}}}}