Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT07064018
Status:
RECRUITING
Last Update Posted:
2025-07-14
First Post:
2025-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine 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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C455861', 'term': 'pegfilgrastim'}, {'id': 'D000069585', 'term': 'Filgrastim'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 67}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2025-05-27', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlation between Tumor FcRn Expression (IHC Score) and Objective Response (per RECIST v1.1)', 'timeFrame': '2 years', 'description': 'E valuate the correlation between tumor neonatal Fc receptor (FcRn) expression, as measured by immunohistochemistry (IHC) H-score, and objective tumor response, defined per RECIST v1.1 criteria (Complete Response or Partial Response).'}, {'measure': 'Correlation between Tumor FcRn Expression (IHC Score) and Disease Control (CR + PR + SD per RECIST v1.1)', 'timeFrame': '2 years', 'description': 'To evaluate the correlation between tumor neonatal Fc receptor (FcRn) expression, as assessed by immunohistochemistry (IHC) H-score, and disease control, defined as the proportion of patients achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST v1.1.'}], 'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR) by RECIST v1.1', 'timeFrame': '2 Years', 'description': 'Sum of Complete Response (CR) and Partial Response (PR) by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR'}, {'measure': 'Disease Control Rate (DCR) by RECIST v1.1', 'timeFrame': '2 Years', 'description': 'Disease Control Rate (DCR) defined as Sum of Stable Disease (SD) + Partial Response (PR) + Complete Response (CR) by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD is defined as an increase of at least 20% in the sum of the longest diameters of the target lesions, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions. Stable Disease (SD) is defined as a tumor that has neither shrunk sufficiently to qualify as a partial response (PR) nor increased sufficiently to qualify as progressive disease (PD).'}, {'measure': 'Complete Response Rate by RECIST v1.1', 'timeFrame': '2 years', 'description': 'Complete Response Rate assessed by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Complete Response (CR) is defined as the disappearance of all target lesions.'}, {'measure': 'Partial Response Rate by RECIST v1.1', 'timeFrame': '2 years', 'description': 'Partial Response rate assessed by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions'}], 'secondaryOutcomes': [{'measure': 'Stable Disease Rate by RECIST v1.1', 'timeFrame': '2 years', 'description': 'Stable Disease Rate by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD is defined as an increase of at least 20% in the sum of the longest diameters of the target lesions, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions. Stable Disease (SD) is defined as a tumor that has neither shrunk sufficiently to qualify as a partial response (PR) nor increased sufficiently to qualify as progressive disease (PD).'}, {'measure': 'Percentage of Responders by RECIST v1.1', 'timeFrame': '2 years', 'description': 'Sum of Complete Response (CR) + Partial Response (PR) to determine Percentage of Responders by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions; Complete Response (CR) is defined as the disappearance of all target lesions. Percentage of Responders (POR) = CR + PR'}, {'measure': 'Overall Survival', 'timeFrame': '2 years', 'description': 'Survival rate of subjects who received at least one dose of Spedox-6.'}, {'measure': 'Progression Free Survival', 'timeFrame': '2 years', 'description': 'Survival rate of subjects who received at least one dose of Spedox-6 without Progression of their disease.'}, {'measure': 'Number of Patients with Grade 3 non-hematological toxicities by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0', 'timeFrame': '2 years', 'description': 'Number of Patients who received at least one dose of Spedox-6 with Grade 3 non-hematological toxicities (excluding alopecia) by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 version 5.0 with the following exceptions: Grade 3 nausea/vomiting or diarrhea \\<72 hours with adequate antiemetic and other supportive care; Grade 3 fatigue \\<1 week; Grade 3 electrolyte abnormality that lasts up to 72 hours, is not clinically complicated and resolves spontaneously or responds to conventional medical interventions.'}, {'measure': 'Number of patients with Grade 4 non-hematologic (non-laboratory) by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 version 5.0', 'timeFrame': '2 years', 'description': 'Number of patients who received at least one dose of Spedox-6 with Grade 4 non-hematologic (non-laboratory) toxicity of any duration per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0'}, {'measure': 'Number of patients with Grade 3 or Grade 4 febrile neutropenia by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 version 5.0', 'timeFrame': '2 years', 'description': 'Number of patients who received at least one dose of Spedox-6 with Grade 3 or Grade 4 febrile neutropenia of any duration per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0'}, {'measure': 'Number of patients with Grade 3 Thrombocytopenia in Combination with Grade 3 or greater blood and lymphatic system disorder by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 version 5.0', 'timeFrame': '2 years', 'description': 'Number of patients who received at least one dose of Spedox-6 with Grade 3 Thrombocytopenia in Combination with Grade 3 or greater blood and lymphatic system disorder per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0'}, {'measure': 'Number of patients with Grade 3 AST or ALT increase that is associated with a Grade 2 or greater Rise in Bilirubin by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 version 5.0', 'timeFrame': '2 years', 'description': 'Number of patients who received at least one dose of Spedox-6 with Grade 3 AST or ALT increase that is associated with a Grade 2 or greater Rise in Bilirubin per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Soft-tissue Sarcoma', 'Triple Negative Breast Cancer', 'Non-small Cell Lung Cancer', 'Cervical Cancer', 'Ovarian Cancer', 'KRAS Mutation-Related Tumors']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1b/IIa dose escalation clinical trial determining the recommended phase II dose of SPEDOX-6 in subjects with advanced, therapy-refractory soft-tissue sarcoma (STS); triple-negative breast cancer (TNBC); Non-small cell lung cancer (NSCLC); cervical cancer; ovarian cancer; KRAS mutant pancreatic ductal adenocarcinoma. These are subjects who have not previously been treated with anthracyclines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects ≥ 18 years at the first screening examination/visit.\n* Subjects with advanced histologically or cytologically confirmed solid tumors (see below) refractory to or relapse from at least two previous therapies.\n* Tumor types expected to express lower levels of FcRn relative to normal tissue including: STS, TNBC, cervical cancer, NSCLC, ovarian cancer, and KRAS mutated pancreatic ductal adenocarcinoma without requirement for testing FcRn level.\n* Disease that is considered measurable by RECIST v1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Life expectancy of at least 12 weeks.\n* Human Immunodeficiency Virus (HIV)-positive trial participants should be on established antiretroviral therapy (ART) for at least four weeks and have an HIV viral load less than 400 copies/mL prior to enrollment.\n* Left ventricular ejection fraction \\> 50%.\n* Adequate organ function: (Hb ≥10 g/dL, ANC ≥1,000/µL3, and platelets\n\n ≥100,000/µL3), serum bilirubin ≤.5x the institutional upper limit of normal (ULN) (unless known Gilbert's disease), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤3x ULN, and creatinine clearance \\>50 mL/min as assessed by Cockcroft-Gault equation.\n* For patients with known Gilbert's disease, serum unconjugated bilirubin must be \\< 4 mg/dL.\n* Patient must have washed out of prior chemotherapy (at least 3 weeks from last end of therapy), radiotherapy (at least 4 weeks from last end of therapy), immunotherapy (at least 4 weeks from last end of therapy), other targeted therapies (at least 4 weeks from last end of therapy), or surgery (at least 4 weeks).\n* Recovery from toxicities of prior therapy. Toxicities should have recovered to CTCAE grade ≤ 1 or baseline with exception of alopecia.\n* Females of reproductive potential must have had a negative pregnancy test performed within 7 days prior to the start of treatment. Additionally, female subjects of reproductive potential should agree to use effective acceptable forms of contraception: surgical sterilization (tubal ligation); total abstinence from sexual intercourse with the opposite sex; established hormonal birth control (e.g., oral, transdermal, injection, or implant) plus a barrier method or a double barrier method (intrauterine device, spermicide, or a diaphragm plus condom) for at least 1 month prior to Cycle 1 Day 1 and agreement to use such a method during study participation and for an additional 6 months after the last dose of SPEDOX-6.\n* For males of reproductive potential: vasectomy or highly effective contraception (e.g., condoms, abstinence) during the study and for an additional 6 months after the last dose of SPEDOX-6.\n\nExclusion Criteria:\n\n* Patients with cancers with known driver mutations for which there are known and effective targeted therapies that have not received those therapies, but are able to. If a patient has received appropriate targeted treatment for their mutations and progressed, or those treatments are contraindicated, they will be considered potentially eligible.\n* Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months before study entry.\n* Untreated metastases to the Central Nervous System (CNS).\n* Have received any prior doxorubicin or anthracycline equivalent.\n* Previous radiation to the mediastinal or pericardial area.\n* A known allergy to albumin.\n* HIV infection with CD4+ count \\< 350 cells/µL or Acquired Immunodeficiency (AIDS)-defining opportunistic infection in previous 12 months.\n* Pregnant (positive serum or urine pregnancy test) or lactating.\n* Previous treatment with an investigational agent or the non-approved use of a drug or device withing 4 weeks of study entry.\n* Uncontrolled diabetes mellitus.\n* Patients who require concomitant use of strong inhibitors or inducers of CYP3A4, CYP2D6 or P-glycoprotein (P-gp)."}, 'identificationModule': {'nctId': 'NCT07064018', 'briefTitle': 'Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Phase Ib/IIa Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies', 'orgStudyIdInfo': {'id': '6228'}, 'secondaryIdInfos': [{'id': 'UCI 24-08', 'type': 'OTHER', 'domain': 'UCI CFCCC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1b Dose Level 1 - Spedox-6', 'description': 'Spedox-6, 20 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.', 'interventionNames': ['Drug: Spedox-6']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b Dose Level 2 - Spedox-6 + Filgrastim/Pegfilgrastim', 'description': 'Spedox-6, 40 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.\n\nFilgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.', 'interventionNames': ['Drug: Spedox-6', 'Drug: Pegfilgrastim', 'Drug: Filgrastim']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b Dose Level 3 - Spedox-6 + Filgrastim/Pegfilgrastim', 'description': 'Spedox-6, 80 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.\n\nFilgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.', 'interventionNames': ['Drug: Spedox-6', 'Drug: Pegfilgrastim', 'Drug: Filgrastim']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b Dose Level 4 - Spedox-6 + Filgrastim/Pegfilgrastim', 'description': 'Spedox-6, 120 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.\n\nFilgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.', 'interventionNames': ['Drug: Spedox-6', 'Drug: Pegfilgrastim', 'Drug: Filgrastim']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b Dose Level 5 - Spedox-6 + Filgrastim/Pegfilgrastim', 'description': 'Spedox-6, 160 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.\n\nFilgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.', 'interventionNames': ['Drug: Spedox-6', 'Drug: Pegfilgrastim', 'Drug: Filgrastim']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b Dose Level 6 - Spedox-6 + Filgrastim/Pegfilgrastim', 'description': 'Spedox-6, 200 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.\n\nFilgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.', 'interventionNames': ['Drug: Spedox-6', 'Drug: Pegfilgrastim', 'Drug: Filgrastim']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b Dose Level 7 - Spedox-6 + Filgrastim/Pegfilgrastim', 'description': 'Spedox-6, 250 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.\n\nFilgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.', 'interventionNames': ['Drug: Spedox-6', 'Drug: Pegfilgrastim', 'Drug: Filgrastim']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b Dose Level 8 - Spedox-6 + Filgrastim/Pegfilgrastim', 'description': 'Spedox-6, 310 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.\n\nFilgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.', 'interventionNames': ['Drug: Spedox-6', 'Drug: Pegfilgrastim', 'Drug: Filgrastim']}], 'interventions': [{'name': 'Spedox-6', 'type': 'DRUG', 'description': 'Given Intravenously (IV)', 'armGroupLabels': ['Phase 1b Dose Level 1 - Spedox-6', 'Phase 1b Dose Level 2 - Spedox-6 + Filgrastim/Pegfilgrastim', 'Phase 1b Dose Level 3 - Spedox-6 + Filgrastim/Pegfilgrastim', 'Phase 1b Dose Level 4 - Spedox-6 + Filgrastim/Pegfilgrastim', 'Phase 1b Dose Level 5 - Spedox-6 + Filgrastim/Pegfilgrastim', 'Phase 1b Dose Level 6 - Spedox-6 + Filgrastim/Pegfilgrastim', 'Phase 1b Dose Level 7 - Spedox-6 + Filgrastim/Pegfilgrastim', 'Phase 1b Dose Level 8 - Spedox-6 + Filgrastim/Pegfilgrastim']}, {'name': 'Pegfilgrastim', 'type': 'DRUG', 'description': 'Given Subcutaneous Injection or IV', 'armGroupLabels': ['Phase 1b Dose Level 2 - Spedox-6 + Filgrastim/Pegfilgrastim', 'Phase 1b Dose Level 3 - Spedox-6 + Filgrastim/Pegfilgrastim', 'Phase 1b Dose Level 4 - Spedox-6 + Filgrastim/Pegfilgrastim', 'Phase 1b Dose Level 5 - Spedox-6 + Filgrastim/Pegfilgrastim', 'Phase 1b Dose Level 6 - Spedox-6 + Filgrastim/Pegfilgrastim', 'Phase 1b Dose Level 7 - Spedox-6 + Filgrastim/Pegfilgrastim', 'Phase 1b Dose Level 8 - Spedox-6 + Filgrastim/Pegfilgrastim']}, {'name': 'Filgrastim', 'type': 'DRUG', 'description': 'Given Subcutaneous Injection or IV', 'armGroupLabels': ['Phase 1b Dose Level 2 - Spedox-6 + Filgrastim/Pegfilgrastim', 'Phase 1b Dose Level 3 - Spedox-6 + Filgrastim/Pegfilgrastim', 'Phase 1b Dose Level 4 - Spedox-6 + Filgrastim/Pegfilgrastim', 'Phase 1b Dose Level 5 - Spedox-6 + Filgrastim/Pegfilgrastim', 'Phase 1b Dose Level 6 - Spedox-6 + Filgrastim/Pegfilgrastim', 'Phase 1b Dose Level 7 - Spedox-6 + Filgrastim/Pegfilgrastim', 'Phase 1b Dose Level 8 - Spedox-6 + Filgrastim/Pegfilgrastim']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Warren Chow, MD', 'role': 'CONTACT', 'email': 'ucstudy@uci.edu', 'phone': '877-827-8839'}], 'facility': 'Chao Family Comprehensive Cancer Center University of California, Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'centralContacts': [{'name': 'Chao Family Comprehensive Cancer Center University of California, Irvine', 'role': 'CONTACT', 'email': 'ucstudy@uci.edu', 'phone': '1-877-827-8839'}, {'name': 'University of California Irvine Medical Center', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Warren Chow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chao Family Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sunstate Biosciences LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor - Division of Hematology-Oncology, Department of Medicine, UCI School of Medicine', 'investigatorFullName': 'Warren Chow', 'investigatorAffiliation': 'University of California, Irvine'}}}}