Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-02-25 @ 4:58 PM
Study NCT ID:
NCT02607202
Status:
COMPLETED
Last Update Posted:
2024-01-26
First Post:
2015-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Nab-paclitaxel-based Doublet as First Line Therapy in Patients With Cancer of Unknown Primary (CUP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009382', 'term': 'Neoplasms, Unknown Primary'}], 'ancestors': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'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'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-25', 'studyFirstSubmitDate': '2015-11-16', 'studyFirstSubmitQcDate': '2015-11-16', 'lastUpdatePostDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR) as evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.', 'timeFrame': '42 months'}], 'secondaryOutcomes': [{'measure': 'duration of response according to RECIST version 1.1.', 'timeFrame': '42 months'}, {'measure': 'time to progression', 'timeFrame': '42 months'}, {'measure': 'overall survival', 'timeFrame': '42 months'}, {'measure': 'toxicity according to Common Terminology Criteria for Adverse Events - CTCAE version 4.03.', 'timeFrame': '42 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Unknown Primary Tumors']}, 'descriptionModule': {'briefSummary': "Agnostos Trial is a multicentric phase 2 randomized trial with a 'pick-the-winner design' in chemonaive patients with cancer of unknown primary. It will assess the efficacy of the two best active single agent - carboplatin or gemcitabine - added to an innovative taxane back bone (nab-Paclitaxel). Agnostos trial is a part of a larger clinical and translational initiative to improve the outlook of patients with cancer of unknown primary through evaluation of novel chemotherapeutic regimens.", 'detailedDescription': 'Treatment-naïve patients with CUP diagnosis confirmed according to CUP Diagnostic Guidelines, will be enrolled into AGNOSTOS trial. Patients will be randomized upfront to receive a nab-paclitaxel-based duplet adding either carboplatin or gemcitabine until progression or unacceptable toxicity (randomization 1:1, n= 120; 60 per arm).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of written informed consent.\n* Patients must be ≥ 18 years of age.\n* Diagnosis of CUP according to CUP Diagnostic Guidelines derived from ESMO 2011 and NCCN 2015 guidelines.\n* Sufficient archived biopsy tissue from a surgical or core needle biopsy required to perform the CUP multiplex assay.\n* Eastern Cooperative Oncology Group performance status ≤ 2.\n* No previous systemic therapy.\n* At least one measurable lesion by RECIST Criteria.\n* Good liver, cardiac, lung and marrow bone function.\n* Evidence of non-childbearing status for female patients: negative urine or serum pregnancy test within 21 days of study treatment for women of childbearing potential, or postmenopausal status.\n* Patients of child bearing potential and their partners, who are sexually active, must agree to the use of highly effective forms of contraception throughout their participation in the study.\n* Patient is willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations.\n\nExclusion Criteria:\n\n* Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, breast Ductal Carcinoma in Situ (DCIS), stage 1 grade 1 endometrial carcinoma.\n* Specific treatable CUP syndromes including: extragonadal germ cell syndrome; neuroendocrine carcinoma; adenocarcinoma isolated to axillary lymph nodes (women cancer); peritoneal carcinomatosis (women - ovarian cancer); squamous carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes; single resectable metastasis.\n* Patients receiving any radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry.\n* Patients with symptomatic uncontrolled brain metastases.\n* Major surgery within 2 weeks of starting the study and patients must have recovered from any effects of any major surgery.\n* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 6 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.\n* Pregnant or breast feeding women.\n* Immunocompromised patients, eg, patients who are known to be serologically positive for human immunodeficiency virus (HIV).\n* Patients with known hepatic disease (eg, Hepatitis B or C).\n* Previous cancer treatment.\n* Patients currently enrolled in another clinical tria, except AGNOSTOS PROFILING.\n* Patients that are receiving chemotherapy, hormonal therapy (HRT is acceptable) or other novel agents.\n* Patients receiving live virus and bacterial vaccines.'}, 'identificationModule': {'nctId': 'NCT02607202', 'acronym': 'AGNOSTOS', 'briefTitle': 'A Study of Nab-paclitaxel-based Doublet as First Line Therapy in Patients With Cancer of Unknown Primary (CUP)', 'organization': {'class': 'OTHER', 'fullName': "Fondazione del Piemonte per l'Oncologia"}, 'officialTitle': 'A Phase II, Randomized, Multicenter Study to Assess the Efficacy of Nab-paclitaxel-based Doublet as First Line Therapy in Patients With Cancer of Unknown Primary (CUP): The AGNOSTOS Trial', 'orgStudyIdInfo': {'id': '008-IRCC-10IIS-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'nab-paclitaxel 125 mg/m2 on Days 1 and 8 by IV administration over 30 minutes without premedication, followed by gemcitabine 1000 mg/m2 on Days 1 and 8 by IV administration over 30 minutes. Treatment to be repeated Q21 days.', 'interventionNames': ['Drug: nab-paclitaxel', 'Drug: Gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'nab-paclitaxel 125 mg/m2 on Days 1 and 8 by IV administration over 30 minutes without premedication, followed by carboplatin AUC 2 on Day 1 and 8 by IV administration over 60 minutes. Treatment to be repeated Q21 days.', 'interventionNames': ['Drug: nab-paclitaxel', 'Drug: Carboplatin']}], 'interventions': [{'name': 'nab-paclitaxel', 'type': 'DRUG', 'otherNames': ['Abraxane'], 'armGroupLabels': ['Arm A', 'Arm B']}, {'name': 'Carboplatin', 'type': 'DRUG', 'armGroupLabels': ['Arm B']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'armGroupLabels': ['Arm A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10060', 'city': 'Candiolo', 'state': 'Turin', 'country': 'Italy', 'facility': 'Investigative Clinical Oncology (Oncologia Medica 2)', 'geoPoint': {'lat': 44.95858, 'lon': 7.59812}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'AOU Policlinoco S Orsola - Malpighi', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'Ospedali Galliera', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Europeo di Oncologia - IEO', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Nazionale dei Tumori', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale Niguarda Cà Granda', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Padua', 'country': 'Italy', 'facility': 'Istituto Oncologico Veneto - IOV', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Pavia', 'country': 'Italy', 'facility': 'Fondazione IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Policlinico Universitario Campus Biomedico', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'A.O.U S.Giovanni Battista', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione del Piemonte per l'Oncologia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}