Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-24 @ 9:29 PM
Study NCT ID:
NCT00539968
Status:
TERMINATED
Last Update Posted:
2015-02-05
First Post:
2007-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel (Study P04467AM1)(TERMINATED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Colombia', 'Ecuador', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland 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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'C115354', 'term': 'lonafarnib'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-04', 'studyFirstSubmitDate': '2007-10-04', 'studyFirstSubmitQcDate': '2007-10-04', 'lastUpdatePostDateStruct': {'date': '2015-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events and dose-limiting toxicities', 'timeFrame': 'Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity'}, {'measure': 'Rate of prostate-specific antigen (PSA) responses', 'timeFrame': 'Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects with dose-limiting toxicities', 'timeFrame': 'Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity'}, {'measure': 'Plasma lonafarnib concentrations', 'timeFrame': 'Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity'}, {'measure': 'RECIST-defined radiological response rate', 'timeFrame': 'Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer', 'Breast Cancer', 'Ovarian Cancer', 'Lung Cancer', 'Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'This study will determine the best doses of docetaxel and lonafarnib when the two anti-cancer agents are used in combination. Patients with tumors for which treatment with docetaxel would be appropriate are eligible. A second part of the study will further examine the effectiveness of the combination treatment in men with prostate cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* For Part 1: Subjects may be male or female and must be at least 18 years of age.\n* For Part 1: Cancer for which docetaxel treatment is appropriate.\n* For Part 1: Docetaxel-naïve\n* For Part 2: Subjects must be male and at least 18 years of age.\n* For Part 2: Subjects must have adenocarcinoma of the prostate confirmed by histologic/cytologic biopsy.\n* For Part 2: Subjects must have progressive, metastatic, AIPC and a PSA of 10 ng/ml or more after hormonal therapy prior to docetaxel treatment. Progressive disease is defined as a consistently increasing serum PSA level within 28 days prior to docetaxel administration.\n* Adequate organ function within 3 weeks prior to first study drug administration.\n* Performance status (ECOG) is less than or equal to 2.\n* Subject understands and agrees to procedures and participation by signing informed consent form.\n* Agrees to use medically accepted form of contraception.\n\nExclusion Criteria:\n\n* Receipt of or need to continue to receive prohibited medications (listed in the protocol) more recently than the washout period (indicated in the protocol).\n* Surgery within 3 weeks prior to first study drug administration.\n* History within 5 years prior to first study drug administration of another malignancy except adequately treated Stage I/II basal/squamous cell skin cancer.\n* Radiation therapy to more than 25% of his/her total bone marrow during life.\n* Radiation therapy within 3 weeks prior to first study drug administration.\n* Known hypersensitivity to prednisone, docetaxel, polysorbate 80, lonafarnib, or any excipients associated with these medications.\n* Known contraindication to steroid use.\n* Known leptomeningeal or CNS metastasis.\n* Heart, vascular, or seizure disorder (detailed list in the protocol) within 6 months prior to first study drug administration.\n* Baseline QTc interval greater than 450 msec.\n* Grade 2 or more peripheral neuropathy or drug-related toxicity per CTCAE. Exceptions are noted in the protocol.\n* Any clinically significant condition or situation that the investigator thinks would interfere with the study evaluations or subject's participation.\n* Subject is part of staff personnel involved in the study.\n* Subject has known clinically significant immunosuppression."}, 'identificationModule': {'nctId': 'NCT00539968', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel (Study P04467AM1)(TERMINATED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label, Two-Part Study to Determine the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel', 'orgStudyIdInfo': {'id': 'P04467'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Docetaxel plus lonafarnib (single arm)', 'description': 'Docetaxel plus lonafarnib', 'interventionNames': ['Drug: Docetaxel plus lonafarnib']}], 'interventions': [{'name': 'Docetaxel plus lonafarnib', 'type': 'DRUG', 'otherNames': ['Docetaxel (Taxotere®); lonafarnib (SCH 066336, Sarasar®)'], 'description': 'Docetaxel: 60-75 mg/m2\n\nLonafarnib: 150-375 mg PO BID', 'armGroupLabels': ['Docetaxel plus lonafarnib (single arm)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}