Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-21 @ 9:48 PM
Study NCT ID:
NCT01325558
Status:
COMPLETED
Last Update Posted:
2016-07-15
First Post:
2011-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of ALT-836 in Combination With Gemcitabine for Locally Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C572574', 'term': 'ALT-836'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-13', 'studyFirstSubmitDate': '2011-03-09', 'studyFirstSubmitQcDate': '2011-03-29', 'lastUpdatePostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) of ALT-836 in combination with gemcitabine', 'timeFrame': '18 months'}, {'measure': 'Safety Profile', 'timeFrame': '18 months', 'description': 'Number and severity of treatment related AEs that occur or worsen after the first dose of study treatment'}, {'measure': 'Clinical Benefit', 'timeFrame': '18 months', 'description': 'Number of participants with complete response, partial response or stable disease'}, {'measure': 'Progression Free Survival', 'timeFrame': '36 months', 'description': 'Number of participants with 9-month, 12-month, 18-month, 24-month, 30-month or 36-month progression-free survival'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '36 months', 'description': 'Number of participants with 9-month, 12-month, 18-month, 24-month, 30-month or 36-month overall survival'}, {'measure': 'Pharmacokinetics', 'timeFrame': '18 months', 'description': 'Area under the plasma concentration-time curve from time zero to infinity (AUC) and the half-life of ALT-836'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cancer', 'tissue factor', 'solid tumor', 'ovarian cancer', 'breast cancer', 'non-small cell lung cancer', 'colon cancer', 'pancreatic cancer', 'head and neck cancer', 'prostate cancer', 'soft-tissue sarcoma', 'metastatic', 'gemcitabine', 'anti-tumor', 'venous thromboembolism'], 'conditions': ['Locally Advanced Malignant Neoplasm', 'Malignant Solid Tumour']}, 'descriptionModule': {'briefSummary': 'This is a Phase I, open-label, multi-center, competitive enrollment and dose-escalation study of ALT-836 in combination with standard of care gemcitabine in participants who have locally advanced or metastatic solid tumors. The purpose of this study is to determine the maximum tolerated dose (MTD), and to assess the safety and pharmacokinetic profile of ALT-836 given with gemcitabine. The clinical benefit, progression-free survival and overall survival of study participants will also be assessed.', 'detailedDescription': 'Tissue Factor (TF) is over-expressed in most cancer types. Results from many recent studies have suggested a key role for TF in the development of cancer-associated thrombosis, tumor growth, tumor angiogenesis, and tumor metastasis. ALT-836, a recombinant human-chimeric monoclonal antibody, is designed as a direct TF antagonist to block TF displayed by cancers and to inhibit cancer-associated venous thromboembolism, tumor growth, tumor angiogenesis and tumor metastasis. In numerous pre-clinical studies in laboratory animals, including non-human primates, ALT-836 exhibits potent anti-tumor, anti-thrombotic and anti-inflammatory activities with a remarkable safety profile. In humans, ALT-836, administered as a single bolus and monotherapy in patients with coronary artery disease (CAD) and acute lung injury/acute respiratory distress syndrome (ALI/ARDS), is safe and exhibits anti-coagulant and anti-inflammatory effects. A Phase II study using a multi-dose regimen of ALT-836 is being conducted in patients with ALI/ARDS. In the dose-escalation study described in this protocol, the investigators will assess the safety and determine the maximum tolerated dose (MTD) of ALT-836 in combination with gemcitabine in patients with advanced malignancies known to overexpress TF and in which venous thromboembolism is a major complication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed\n* Locally advanced or metastatic non-hematologic malignancies\n* Measureable\n* Refractory to standard therapies or single agent gemcitabine is indicated as a standard treatment option\n\nPRIOR/CONCURRENT THERAPY:\n\n* No concurrent radiotherapy, chemotherapy, immunotherapy or other investigational agents\n* Must have recovered from side effects of prior therapies\n\nPATIENT CHARACTERISTICS:\n\nLife expectancy\n\n* \\> 12 weeks\n\nPerformance Status\n\n* ECOG 0 or 1\n\nBone Marrow Reserve\n\n* Absolute Neutrophil count (AGC/ANC) ≥ 1,500/uL\n* Platelets ≥ 100,000/uL\n* Hemoglobin \\> 9 g/dL\n\nRenal Function\n\n* Calculated Glomerular filtration rate (GFR) \\> 59mL/min/1.73M\\^2\n\nHepatic Function\n\n* Total bilirubin ≤ 1.5 X ULN\n* AST, ALT, and ALP ≤ 3 X ULN or ≤ 5.0 x ULN, if liver metastasis exists\n* PT INR ≤ 1.5 X ULN\n\nCardiovascular\n\n* No history of clinically significant vascular disease\n* No New York Heart Association (NYHA) Class \\> II heart failure\n\nHematologic\n\n* No history of bleeding disorders\n* No evidence of bleeding diathesis or coagulopathy\n* No presence of clinically significant hemoptysis or hematuria, presence of serious non-healing wound or ulceration, or signs of other bleeding\n* No evidence of a tumor invasion of any major blood vessel\n* No trauma with increased risk of life-threatening bleeding or history of severe head trauma or intracranial surgery within two months of study entry\n\nSurgery/Procedures\n\n* No major surgery or open biopsy within 28 days before drug infusion or evidence of active bleeding postoperatively\n* No plan for any major surgery during treatment period\n* No presence or requirement of an epidural catheter or lumbar puncture within 48 hours prior to each dose of study treatment\n* No anticipation of receiving an epidural catheter or a lumbar puncture within 48 hours after each dose of study treatment\n\nExcluded Medications or Treatment Regimens\n\n* Unfractionated heparin of \\> 15,000 units/day within 8 hours prior to each dose of study treatment\n* Low-molecular weight heparin at a higher dose than recommended for prophylactic used or required within 20 hours prior to each dose of study treatment\n* Warfarin used or required within 48 hours prior to each dose of study treatment and the prothrombin time (INR) exceeded the upper limit of normal range\n* Direct thrombin inhibitors or Xa inhibitors\n* Acetylsalicylic acid used or required within 72 hours prior to each dose of study treatment\n* Clopidogrel bisulfate used or required within 48 hours prior to each dose of study treatment\n* Anticipated requirement for anti-platelet or anti-coagulant agents excluding non-aspirin NSAID within 48 hours following study treatment infusion\n\nOther\n\n* No active systemic infection requiring parenteral antibiotic therapy\n* No history of or presence of a CNS disease\n* No history of allergic reactions to compounds of similar chemical or biologic composition\n* Not HIV positive\n* No women who are pregnant or nursing\n* A negative serum pregnancy test if female\n* Patients, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study\n* No history of significant renal, endocrinologic, metabolic, immunologic or hepatic disease\n* No evidence of psychiatric illness/social situations\n* Other illness that in the opinion of the investigator would exclude the patient from participating\n* Must provide informed consent and HIPAA authorization and comply with protocol-specified procedures and follow-up evaluations'}, 'identificationModule': {'nctId': 'NCT01325558', 'briefTitle': 'A Study of ALT-836 in Combination With Gemcitabine for Locally Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Altor BioScience'}, 'officialTitle': 'A Phase I, Open-Label, Multi-center, Competitive Enrollment and Dose-escalation Study of ALT-836 in Combination With Gemcitabine for Locally Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'CA-ALT-836-02-10'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ALT-836 in combination with gemcitabine', 'type': 'BIOLOGICAL', 'description': 'Study participants will receive up to four courses of a 28-day biochemotherapy with the study drug (ALT-836) and gemcitabine. Each treatment course consists of five doses of ALT-836 (on Day 1, 4, 8, 15 and 22) and three doses of gemcitabine (Day 1, 8 and 15). Participants with persistent responses will receive additional two cycles, three doses each, of standard of care gemcitabine therapy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University, Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center, James P. Wilmot Cancer Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Hematology-Oncology Associates', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Altor BioScience', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}