Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-28 @ 7:01 PM
Study NCT ID:
NCT06136650
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2023-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C034635', 'term': 'fludrocortisone acetate'}, {'id': 'D006854', 'term': 'Hydrocortisone'}, {'id': 'D000069501', 'term': 'Abiraterone Acetate'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'C540278', 'term': 'enzalutamide'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D011244', 'term': 'Pregnadienediols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1314}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-12-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2023-11-13', 'studyFirstSubmitQcDate': '2023-11-13', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic Progression-Free Survival (rPFS)', 'timeFrame': 'Up to approximately 52 months', 'description': 'rPFS is defined as the time from randomization to the first documented disease progression per PCWG-modified RECIST 1.1 by BICR or death due to any cause, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 82 months', 'description': 'OS is defined as the time from randomization to death due to any cause.'}, {'measure': 'Time to Initiation of the First Subsequent Anticancer Therapy (TFST)', 'timeFrame': 'Up to approximately 82 months', 'description': 'TFST is defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death, whichever occurred first.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 82 months', 'description': 'ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per PCWG-modified RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 82 months', 'description': 'For participants who demonstrate confirmed CR or PR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression per PCWG-modified RECIST 1.1 as assessed by BICR or death from any cause, whichever occurs first.'}, {'measure': 'Time to Pain Progression (TTPP)', 'timeFrame': 'Up to approximately 82 months', 'description': 'TTPP is defined as the time from randomization to pain progression. TTTP is assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and opiate analgesic use (Analgesic Quantification Algorithm \\[AQA\\] Score).'}, {'measure': 'Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Total Score', 'timeFrame': 'Baseline and up to approximately 82 months', 'description': 'The FACT-G is a health-related quality of life (HRQoL) 27-item questionnaire in participants being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 (not at all) to 4 (very much). The total score can range from 0 to 108. Higher scores indicate higher HRQoL. The change from baseline in FACT-G total score will be reported.'}, {'measure': 'Time to Deterioration (TTD) in FACT-G Total Score', 'timeFrame': 'Up to approximately 82 months', 'description': 'The FACT-G is a HRQoL 27-item questionnaire in participants being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 (not at all) to 4 (very much). The total score can range from 0 to 108. Higher scores indicate higher HRQoL. TTD in FACT-G total score will be reported.'}, {'measure': 'Overall Improvement in FACT-G Total Score', 'timeFrame': 'Up to approximately 82 months', 'description': 'The FACT-G is a HRQoL 27-item questionnaire in participants being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 (not at all) to 4 (very much). The total score can range from 0 to 108. Higher scores indicate higher HRQoL. The overall improvement in FACT-G total score will be reported.'}, {'measure': 'Time to Prostate-specific Antigen (PSA) Progression', 'timeFrame': 'Up to approximately 82 months', 'description': 'The time to PSA progression is the time from randomization to PSA progression. The PSA progression date is defined as the date of: 1) ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there was PSA decline from baseline; OR 2) ≥25% increase and ≥2 ng/mL increase from baseline.'}, {'measure': 'PSA Response Rate', 'timeFrame': 'Up to approximately 82 months', 'description': 'The PSA response rate is the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level was confirmed by an additional PSA evaluation performed ≥3 weeks from the original response.'}, {'measure': 'Time to First Symptomatic Skeletal-Related Event (TSSRE)', 'timeFrame': 'Up to approximately 82 months', 'description': 'TSSRE is the time from randomization to the first symptomatic skeletal-related event defined as: 1. use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms 2. occurrence of new symptomatic pathologic bone fracture (vertebral or non-vertebral) 3. occurrence of spinal cord compression 4. tumor-related orthopedic surgical intervention, whichever occurs first.'}, {'measure': 'Number of Participants Who Experience an AE', 'timeFrame': 'Up to approximately 82 months', 'description': 'An AE is defined as any unfavorable and unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience one or more AE will be reported.'}, {'measure': 'Number of Participants Who Discontinue Study Treatment Due to an AE', 'timeFrame': 'Up to approximately 82 months', 'description': 'An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be reported.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Castration-resistant Prostate Cancer (mCRPC)', 'Prostatic Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26280&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypothesis is that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as assessed by Blinded Independent Central Review (BICR), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.', 'detailedDescription': 'Per Protocol Amendment 08, overall survival (OS) was moved to be a secondary outcome measure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology\n* Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening\n* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography (CT)/magnetic resonance imaging (MRI)\n* Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) (metastatic hormone-sensitive prostate cancer \\[mHSPC\\] or non-metastatic hormone-sensitive prostate cancer \\[nmHSPC\\]), or castration-resistant prostate cancer (CRPC) (metastatic castration-resistant prostate cancer \\[mCRPC\\] or non-metastatic castration-resistant prostate cancer \\[nmCRPC\\]), for at least 8 weeks of NHA treatment (at least 14 weeks of NHA treatment for participants with bone progression). Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than 6 cycles of docetaxel and had no radiographic disease progression while receiving docetaxel\n* Has had prior treatment with poly (ADP-ribose) polymerase inhibitor (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment\n* Has ongoing androgen deprivation therapy (ADT) with serum testosterone \\<50 ng/dL (\\<1.7 nM)\n* Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 10 days before randomization\n* Has adequate organ function\n* Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Participants who have adverse event (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy (HRT) or participants who have ≤Grade 2 neuropathy or ≤Grade 2 osteopenia/osteoporosis are eligible\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has presence of gastrointestinal condition\n* Is unable to swallow capsules/tablets\n* Has history of pituitary dysfunction\n* Has poorly controlled diabetes mellitus\n* Has clinically significant abnormal serum potassium or sodium level\n* Has any of the following at screening visit: Hypotension: systolic blood pressure (BP) \\<110 mmHg, or uncontrolled hypertension: systolic BP ≥160mmHg or diastolic blood BP ≥90 mmHg, in 2 out of the 3 recordings with optimized antihypertensive therapy\n* Has a history of active or unstable cardio/cerebrovascular disease, including thromboembolic events\n* History or family history of long QTc syndrome\n* Has a history of seizure(s) within 6 months before providing documented informed consent (IC) or has any condition that may predispose to seizure within 12 months prior to the date of enrollment\n* Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place\n* Has received a taxane-based chemotherapy for metastatic castration-resistant prostate cancer (mCRPC)\n* Has not adequately recovered from major surgery or have ongoing surgical complications\n* Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures\n* Participants on an unstable dose of thyroid hormone therapy, as judged by the investigator, within 6 months before the start of the study intervention\n* Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids\n* Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention\n* Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention\n* Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat\n* Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication\n* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days prior to the first dose of study intervention\n* Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed\n* Active infection requiring systemic therapy\n* Has concurrent active Hepatitis B virus and Hepatitis C virus infection'}, 'identificationModule': {'nctId': 'NCT06136650', 'briefTitle': 'A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) (OMAHA-004)', 'orgStudyIdInfo': {'id': '5684-004'}, 'secondaryIdInfos': [{'id': 'MK-5684-004', 'type': 'OTHER', 'domain': 'MSD'}, {'id': 'jRCT2031240030', 'type': 'REGISTRY', 'domain': 'Japan Registry of Clinical Trial (jRCT)'}, {'id': '2023-504957-11-00', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'U1111-1288-5002', 'type': 'REGISTRY', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hormone Replacement Therapy (HRT) + Opevesostat', 'description': 'Participants receive opevesostat 5 mg by oral tablets twice daily (BID) plus dexamethasone 1.5 mg by oral tablets and fludrocortisone acetate 0.1 mg oral tablet once daily (QD) continuously until disease progression. Hydrocortisone 100 mg (oral or intramuscular \\[IM\\]) will also be provided to participants for use as rescue medication.', 'interventionNames': ['Drug: Opevesostat', 'Drug: Dexamethasone', 'Drug: Fludrocortisone acetate', 'Drug: Hydrocortisone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alternative Next-Generation Hormonal Agent (NHA)', 'description': 'Participants receive abiraterone 1000mg QD by oral tablets plus prednisone 5 mg BID by oral tablets or enzalutamide 160 mg QD by oral tablets until disease progression.', 'interventionNames': ['Drug: Abiraterone acetate', 'Drug: Prednisone acetate', 'Drug: Enzalutamide']}], 'interventions': [{'name': 'Opevesostat', 'type': 'DRUG', 'otherNames': ['MK-5684'], 'description': 'Administered orally', 'armGroupLabels': ['Hormone Replacement Therapy (HRT) + Opevesostat']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Hormone Replacement Therapy (HRT) + Opevesostat']}, {'name': 'Fludrocortisone acetate', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Hormone Replacement Therapy (HRT) + Opevesostat']}, {'name': 'Hydrocortisone', 'type': 'DRUG', 'description': 'Administered orally or IM as a rescue drug', 'armGroupLabels': ['Hormone Replacement Therapy (HRT) + Opevesostat']}, {'name': 'Abiraterone acetate', 'type': 'DRUG', 'otherNames': ['Zytiga', 'Yonsa'], 'description': 'Administered orally', 'armGroupLabels': ['Alternative Next-Generation Hormonal Agent (NHA)']}, {'name': 'Prednisone acetate', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Alternative Next-Generation Hormonal Agent (NHA)']}, {'name': 'Enzalutamide', 'type': 'DRUG', 'otherNames': ['Xtandi'], 'description': 'Administered orally', 'armGroupLabels': ['Alternative Next-Generation Hormonal Agent (NHA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '520-626-1068'}], 'facility': 'The University of Arizona Cancer Center - North Campus ( Site 0073)', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90404', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'UCLA Hematology/Oncology - Santa Monica ( Site 0044)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040)', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Arash Rezazadeh Kalebasty', 'role': 'CONTACT', 'email': 'arez@hs.uci.edu', 'phone': '502-472-3237'}], 'facility': 'University of California, Irvine (UCI) Health - UC Irvine Medical Center (0120)', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Stanford Cancer Center ( Site 0036)', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92373', 'city': 'Redlands', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Emad Ibrahim,MD,INC. ( Site 0012)', 'geoPoint': {'lat': 34.05557, 'lon': -117.18254}}, {'zip': '92505', 'city': 'Riverside', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Kaiser Permanente Riverside Medical Center ( Site 0099)', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '916-734-3772'}], 'facility': 'University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 0114)', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'San Francisco VA Health Care System ( Site 0093)', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94589', 'city': 'Vallejo', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Kaiser Permanente-Kaiser Permanente, Vallejo Medical Center, Adult Oncology ( Site 0101)', 'geoPoint': {'lat': 38.10409, 'lon': -122.25664}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus ( Site 0046)', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80129', 'city': 'Highlands Ranch', 'state': 'Colorado', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'UCHealth Highlands Ranch Hospital ( Site 0111)', 'geoPoint': {'lat': 39.55388, 'lon': -104.96943}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Colorado Clinical Research ( Site 0067)', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '80124', 'city': 'Lone Tree', 'state': 'Colorado', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'University of Colorado Health - Lone Tree Medical Center ( Site 0112)', 'geoPoint': {'lat': 39.55171, 'lon': -104.8863}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Yale-New Haven Hospital-Yale Cancer Center ( Site 0064)', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'MedStar Washington Hospital Center ( Site 0103)', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Florida Cancer Specialists - South ( Site 7003)', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Mount Sinai Cancer Center ( Site 0107)', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '33028', 'city': 'Pembroke Pines', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '954-265-4325'}], 'facility': 'Memorial Hospital West-Memorial Cancer Institute ( Site 0109)', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Northside Hospital-Northside Hospital Oncology Network ( Site 0100)', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60126', 'city': 'Elmhurst', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. 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