Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-28 @ 9:24 AM
Study NCT ID:
NCT01930292
Status:
TERMINATED
Last Update Posted:
2016-03-24
First Post:
2013-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Debio 1143 in Combination With Carboplatin and Paclitaxel in Patient With Advanced Solid Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], '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'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'whyStopped': 'Part B was cancelled based on business decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-23', 'studyFirstSubmitDate': '2013-06-21', 'studyFirstSubmitQcDate': '2013-08-27', 'lastUpdatePostDateStruct': {'date': '2016-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: Number of participants with dose-limiting toxicities', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: each Debio 1143 dose level and overall'}, {'measure': 'Part B: Percentage of participants with adverse events (AEs) and serious AEs (SAEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria', 'timeFrame': 'up to 18 weeks + 28 days'}], 'secondaryOutcomes': [{'measure': 'Part A: Percentage of participants with AEs and serious adverse events (SAEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria', 'timeFrame': 'up to 18 weeks + 28 days', 'description': 'Categories: each Debio 1143 dose level and overall'}, {'measure': 'Part A: Number of participants with change in vital signs', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: each Debio 1143 dose level and overall'}, {'measure': 'Part A: Number of participants with change in electrocardiogram (ECG)', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: each Debio 1143 dose level and overall'}, {'measure': 'Part A: Number of participants with change in Eastern Cooperative Oncology Group (ECOG) performance status (PS)', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: each Debio 1143 dose level and overall'}, {'measure': 'Part B: Number of participants with change in vital signs', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: each indication at the recommended dose (RD)'}, {'measure': 'Part B: Number of participants with change in electrocardiogram (ECG)', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: each indication at the recommended dose (RD)'}, {'measure': 'Part B: Number of participants with change in Eastern Cooperative Oncology Group (ECOG) performance status (PS)', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: each indication at the recommended dose (RD)'}, {'measure': 'Part A: Percentage of participants with incidence of laboratory abnormalities according to NCI-CTCAE criteria', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: each Debio 1143 dose level and overall'}, {'measure': 'Part B: Percentage of participants with incidence of laboratory abnormalities according to NCI-CTCAE criteria', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: each indication at the RD'}, {'measure': 'Part A: Percentage of participants with treatment discontinuations due to AEs and SAEs', 'timeFrame': 'up to 18 weeks + 28 days', 'description': 'Categories: each Debio 1143 dose level and overall'}, {'measure': 'Part B: Percentage of participants with treatment discontinuations due to AEs and SAEs', 'timeFrame': 'up to 18 weeks + 28 days', 'description': 'Categories: each indication at the RD'}, {'measure': 'Part A: Number of participants with change in left ventricular ejection fraction (LVEF)', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: each Debio 1143 dose level and overall'}, {'measure': 'Part B: Number of participants with change in left ventricular ejection fraction (LVEF)', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: each indication at the RD'}, {'measure': 'Part A: Number of participants with tumour response: disease control, change in tumour size from baseline and overall response', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: each Debio 1143 dose level and overall'}, {'measure': 'Part B: Number of participants with tumour response: disease control, change in tumour size from baseline and overall response', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: each indication at the RD'}, {'measure': 'Part A: Percentage of participants with progression-free survival (PFS) at 6 months', 'timeFrame': 'at 6 months', 'description': 'Categories: each Debio 1143 dose level and overall'}, {'measure': 'Part B: Percentage of participants with progression-free survival (PFS) at 6 months', 'timeFrame': 'at 6 months', 'description': 'Categories: each indication at the RD'}, {'measure': 'Part A: Percentage of participants with survival at 1 year', 'timeFrame': 'at 12 months', 'description': 'Categories: each Debio 1143 dose level and overall'}, {'measure': 'Part B: Percentage of participants with survival at 1 year', 'timeFrame': 'at 12 months', 'description': 'Categories: each indication at the RD'}, {'measure': 'Part B: Maximum concentration (Cmax) in the pharmacokinetic (PK) subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: Debio 1143 alone; Debio 1143 when administered with paclitaxel and carboplatin; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143'}, {'measure': 'Part B: Lowest concentration before the next dose (Ctrough) of Debio 1143 in the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: alone and in combination with chemotherapy'}, {'measure': 'Part B: Time to maximum concentration (tmax) in the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: Debio 1143 alone; Debio 1143 when administered with paclitaxel and carboplatin; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143'}, {'measure': 'Part B: Area under the concentration versus time curve from the beginning to a point in time (AUC0-t) in the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: Debio 1143 alone; Debio 1143 when administered with paclitaxel and carboplatin; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143'}, {'measure': 'Part B: Area under the concentration versus time curve extrapolated to infinity (AUC∞) in the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: Debio 1143 alone; Debio 1143 when administered with paclitaxel and carboplatin; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143'}, {'measure': 'Part B: Terminal rate constant (λz) in the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: Debio 1143 alone; Debio 1143 when administered with paclitaxel and carboplatin; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143'}, {'measure': 'Part B: Apparent terminal half-life (t½) in the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: Debio 1143 alone; Debio 1143 when administered with paclitaxel and carboplatin; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143'}, {'measure': 'Part B: Mean residence time (MRT) in the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: Debio 1143 alone; Debio 1143 when administered with paclitaxel and carboplatin; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143'}, {'measure': 'Part B: Apparent clearance (CL/F) of Debio 1143 in the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: alone and in combination with chemotherapy'}, {'measure': 'Part B: Apparent volume of distribution during the terminal phase (Vz/F) of Debio 1143 in the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: alone and in combination with chemotherapy'}, {'measure': 'Part B: Total amount of Debio 1143 excreted in urine (Ae) in the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: alone and in combination with chemotherapy'}, {'measure': 'Part B: Total amount of Debio 1143 excreted in urine in the first 8 hours (Ae0-8) in the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: alone and in combination with chemotherapy'}, {'measure': 'Part B: Total amount of Debio 1143 excreted in urine between 8 and 24 hours (Ae8-24) in the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: alone and in combination with chemotherapy'}, {'measure': 'Part B: Renal clearance calculated as Ae/AUC∞ (CLR) of Debio 1143 in the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: alone and in combination with chemotherapy'}, {'measure': 'Part B: Fraction of the dose excreted in urine calculated as Ae/dose (fe) of Debio 1143 in the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: alone and in combination with chemotherapy'}, {'measure': 'Part B: Area under the concentration versus time curve in the first 12 hours (AUC0-12) in the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143'}, {'measure': 'Part B: Total body clearance (CL) in the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143'}, {'measure': 'Part B: Volume of distribution at steady-state (Vss) in the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143'}, {'measure': 'Part B: Mean Residence Area under the concentration versus time curve (MR,AUC) in the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143'}, {'measure': 'Part B: Mean Residence Maximum Concentration (MR,Cmax) in the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143'}, {'measure': 'Part B: Platinum Refraction (PtR) in ovarian cancer participants included in the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143'}, {'measure': 'Part B: Cmax in patients other than the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143'}, {'measure': 'Part B: Concentration observed at time n (Cn) following Debio 1143 administration in patients other than the PK subset', 'timeFrame': 'up to 18 weeks', 'description': 'Categories: paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Solid Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.debiopharm.com', 'label': 'Site Debiopharm SA'}]}, 'descriptionModule': {'briefSummary': 'This is a two-part trial in patients with squamous non-small cell lung cancer (NSCLC), platinum (Pt)-refractory ovarian cancer, and basal-like/claudin low triple negative breast cancer (TNBC).\n\nThe primary objective of Part A is to determine the maximum tolerated dose (MTD) of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin.\n\nThe primary objective of Part B is to consolidate the safety profile of the recommended dose of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meets protocol-specified criteria for qualification and contraception\n* Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications\n* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures\n\nExclusion Criteria:\n\n* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters\n* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:\n\n 1. the safety or well-being of the participant or study staff;\n 2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); or\n 3. the analysis of results"}, 'identificationModule': {'nctId': 'NCT01930292', 'briefTitle': 'Debio 1143 in Combination With Carboplatin and Paclitaxel in Patient With Advanced Solid Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Debiopharm International SA'}, 'officialTitle': 'A Phase I Study to Evaluate the Safety and Determine the Maximum Tolerated Dose (MTD) of Debio 1143 Combined With Carboplatin and Paclitaxel in Patients With Squamous Non-Small Cell Lung Cancer (NSCLC), Platinum-refractory Ovarian Cancer, and Basal-like/Claudin Low Triple Negative Breast Cancer (TNBC)', 'orgStudyIdInfo': {'id': 'Debio 1143-103'}, 'secondaryIdInfos': [{'id': '2012-003676-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: Debio 1143', 'description': 'Eligible participants receive Part A: Debio 1143 once daily for 5 consecutive days in each 21-day treatment cycle according to dose escalation rules (in combination with Paclitaxel and Carboplatin standard of care)', 'interventionNames': ['Drug: Part A: Debio 1143', 'Drug: Paclitaxel', 'Drug: Carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Lung Cancer', 'description': 'Participants with Lung Cancer receive Part B: Debio 1143 once daily for 5 consecutive days in each 21-day treatment cycle (in combination with Paclitaxel and Carboplatin standard of care)', 'interventionNames': ['Drug: Paclitaxel', 'Drug: Carboplatin', 'Drug: Part B: Debio 1143']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Ovarian Cancer', 'description': 'Participants with Ovarian Cancer receive Part B: Debio 1143 once daily for 5 consecutive days in each 21-day treatment cycle (in combination with Paclitaxel and Carboplatin standard of care)', 'interventionNames': ['Drug: Paclitaxel', 'Drug: Carboplatin', 'Drug: Part B: Debio 1143']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Breast Cancer', 'description': 'Participants with Breast Cancer receive Part B: Debio 1143 once daily for 5 consecutive days in each 21-day treatment cycle (in combination with Paclitaxel and Carboplatin standard of care)', 'interventionNames': ['Drug: Paclitaxel', 'Drug: Carboplatin', 'Drug: Part B: Debio 1143']}], 'interventions': [{'name': 'Part A: Debio 1143', 'type': 'DRUG', 'description': 'Adaptive doses of Debio1143 oral capsules, between 50 and 400 mg until the recommended dose (RD) is determined.', 'armGroupLabels': ['Part A: Debio 1143']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Paclitaxel standard of care, intravenous (IV), once on day 1 or 2 of each 21-day treatment cycle, after pre-medication to prevent severe hypersensitivity reactions.', 'armGroupLabels': ['Part A: Debio 1143', 'Part B: Breast Cancer', 'Part B: Lung Cancer', 'Part B: Ovarian Cancer']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin standard of care, intravenous (IV), once on day 1 or 2 of each 21-day treatment cycle.', 'armGroupLabels': ['Part A: Debio 1143', 'Part B: Breast Cancer', 'Part B: Lung Cancer', 'Part B: Ovarian Cancer']}, {'name': 'Part B: Debio 1143', 'type': 'DRUG', 'description': 'RD of Debio1143 oral capsules, once daily for five consecutive days starting on day 1 or 2 of each 21-day treatment cycle.', 'armGroupLabels': ['Part B: Breast Cancer', 'Part B: Lung Cancer', 'Part B: Ovarian Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Georges François Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75248', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31052', 'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Jean-Pierre Delord, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut Claudius Regaud, Toulouse, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Debiopharm International SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}