navitoclax (ABT 263) / AbbVie  >>  Phase 1
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24 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
navitoclax (ABT 263) / AbbVie
NCT04480086: Safety and Tolerability Study of Mivebresib Tablet Alone or in Combination With Ruxolitinib Tablet or Navitoclax Tablet in Adult Participants With Myelofibrosis

Terminated
1b
1
US, RoW
Mivebresib, Navitoclax, ABT-263, Ruxolitinib
AbbVie
Myelofibrosis (MF)
07/23
07/23
ITALLI001, NCT05054465: A Phase 1b-2 Trial to Assess Venetoclax and Navitoclax Consolidation and Post-transplant Maintenance in High-risk Patients With T-ALL

Not yet recruiting
1b
48
RoW
Navitoclax, Venetoclax
Israeli Medical Association, Rabin Medical Center, Sheba Medical Center, Rambam Health Care Campus, Tel Aviv Medical Center, Soroka University Medical Center, Shaare Zedek Medical Center, Hadassah Medical Center
Acute Lymphoblastic Leukemia
08/25
08/26
NCT01053520: Assess the Oral Bioavailability of a New ABT-263 Formulation in Healthy Female Subjects

Completed
1
12
US
ABT-263
Abbott, Genentech, Inc.
Healthy Female Subjects
12/09
01/10
NCT00743028: Assess the Oral Bioavailability of New ABT-263 Formulations

Completed
1
36
US
ABT-263
Abbott, Genentech, Inc.
Chronic Lymphocytic Leukemia, Lymphomas, Leukemias
08/10
 
NCT00982566: Assess the Oral Bioavailability of a New ABT-263 Formulation in Subjects With Cancer

Completed
1
37
NA
ABT-263
AbbVie, Genentech, Inc.
Lymphoid Malignancy, Solid Tumors
10/10
12/10
NCT01021358: A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-263 (Navitoclax).

Checkmark In combination with ketoconazole in cancer pts
Apr 2014 - Apr 2014: In combination with ketoconazole in cancer pts
Completed
1
12
US
ABT-263, Ketoconazole
Abbott
Lymphoma, Chronic Lymphocytic Leukemia, Solid Tumors
10/10
 
NCT01121133: A Study to Assess the Effect of Rifampin on the Metabolism of Navitoclax

Completed
1
12
NA
navitoclax, ABT-263, navitoclax, Rifampin
AbbVie
Lymphoma, Including Chronic Lymphocytic Leukemia, Solid Tumors
05/11
05/11
NCT00878449: A Study Evaluating the Safety of ABT-263 in Combination With Etoposide/Cisplatin in Subjects With Cancer

Completed
1
12
US
ABT-263, etoposide/cisplatin
AbbVie (prior sponsor, Abbott), Genentech, Inc.
Solid Tumors
07/11
07/11
NCT00887757: Safety Study of ABT-263 in Combination With Gemzar (Gemcitabine) in Subjects With Solid Tumors

Checkmark P1 data, 1st line, solid tumors
Jun 2011 - Jun 2011: P1 data, 1st line, solid tumors
Completed
1
46
NA
ABT-263, navitoclax, gemcitabine, gemzar, gemcitabine
AbbVie, Genentech, Inc.
Solid Tumors
11/11
11/11
NCT00888108: Safety Profile, MTD, and PK Profile Studies of ABT-263 When Administered in Combination With Standard and Weekly Regimens of Docetaxel in Subjects With Cancer

Checkmark P1 data 1st line solid tumors
Jun 2011 - Jun 2011: P1 data 1st line solid tumors
Completed
1
41
US, Europe
ABT-263, Docetaxel, docetaxel, taxotere
Abbott, Genentech, Inc.
Solid Tumor
03/12
03/12
NCT00891605: Safety Study of ABT-263 in Combination With Paclitaxel in Subjects With Solid Tumors

Completed
1
19
NA
ABT-263, Navitoclax, paclitaxel, Taxol
AbbVie, Genentech, Inc.
Solid Tumors
07/12
07/12
NCT00868413: Study of ABT-263 When Administered in Combination With Either Fludarabine/Cyclophosphamide/Rituximab or Bendamustine/Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia

Checkmark P1 data - EHA
Jun 2012 - Jun 2012: P1 data - EHA
Checkmark P1 data -EHA
May 2012 - May 2012: P1 data -EHA
Checkmark P1 data in CLL
More
Completed
1
32
US
ABT-263, FCR, fludarabine, cyclophosphamide, rituximab, BR, bendamustine, rituximab
AbbVie (prior sponsor, Abbott), Genentech, Inc.
Chronic Lymphocytic Leukemia
05/13
05/13
NCT01009073: A Study Evaluating ABT-263 With Erlotinib, ABT-263 With Irinotecan, and ABT-263 Monotherapy in Cancer Subjects

Completed
1
51
US
ABT-263, erlotinib, irinotecan (3-week schedule), irinotecan (weekly schedule)
AbbVie (prior sponsor, Abbott)
Solid Tumors
06/13
06/13
NCT03181126 / 2017-001541-26: A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma

Completed
1
69
US, RoW
Navitoclax, ABT-263, Chemotherapy, Venetoclax, ABT-199 GDC-0199
AbbVie
Acute Lymphoblastic Leukemia (ALL), Lymphoblastic Lymphoma
11/20
11/20
NCT02143401: Navitoclax and Sorafenib Tosylate in Treating Patients With Relapsed or Refractory Solid Tumors

Completed
1
29
US
Laboratory Biomarker Analysis, Navitoclax, A-855071.0, ABT-263, BcI-2 Family Protein Inhibitor ABT-263, Pharmacological Study, Sorafenib, BA4 43 9006, BAY 43 9006, BAY 43-9006, BAY 439006, BAY-43-9006, Bay-439006, BAY439006, Sorafenib Tosylate, BAY 43-9006 Tosylate, BAY 54 9085, BAY 54-9085, BAY 549085, BAY-54-9085, BAY549085, Nexavar, sorafenib
National Cancer Institute (NCI)
Cirrhosis, Hepatitis B Infection, Hepatitis C Infection, Metastatic Malignant Solid Neoplasm, Recurrent Hepatocellular Carcinoma, Recurrent Malignant Solid Neoplasm, Refractory Malignant Neoplasm, Stage IV Hepatocellular Carcinoma AJCC v7, Unresectable Solid Neoplasm
11/22
03/24
NCT05222984: Navitoclax, Venetoclax, and Decitabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Previously Treated With Venetoclax

Active, not recruiting
1
17
US
Decitabine, 5-Aza-2'-deoxycytidine, Dacogen, Decitabine for Injection, Deoxyazacytidine, Dezocitidine, Navitoclax, A-855071.0, ABT-263, BcI-2 Family Protein Inhibitor ABT-263, Venetoclax, ABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, Venclyxto
City of Hope Medical Center, National Cancer Institute (NCI)
Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
04/26
04/26
Exactis-03, NCT05358639: Combination of Olaparib and Navitoclax in Women with HGSC and TNBC

Active, not recruiting
1
36
Canada
Olaparib tablet, Lynparza, Navitoclax, ABT-263
Sunnybrook Health Sciences Centre, Exactis Innovation, Centre hospitalier de l'Université de Montréal (CHUM), Princess Margaret Hospital, Canada
High Grade Serous Carcinoma, Triple Negative Breast Cancer, Ovarian Cancer
03/25
04/25
NCT00788684: Safety Study of ABT-263 in Combination With Rituximab in Lymphoid Cancers

Checkmark P1 data (Lymphoid cancer, +rituximab)
Dec 2010 - Dec 2011: P1 data (Lymphoid cancer, +rituximab)
Completed
1
29
US, RoW
rituximab, Rituxan, ABT-263, navitoclax
AbbVie, Genentech, Inc.
CD20-Positive Lymphoid Malignancies, Chronic Lymphoid Leukemia, Hematological Malignancies, Non-Hodgkin's Lymphoma
02/25
02/25
NCT04454658: Safety and Tolerability Study of Oral ABBV-744 Tablet Alone or in Combination With Oral Ruxolitinib Tablet or Oral Navitoclax Tablet in Adult Participants With Myelofibrosis

Active, not recruiting
1
21
Europe, Japan, US, RoW
ABBV-744, Navitoclax, ABT-263, Ruxolitinib
AbbVie
Myelofibrosis (MF)
01/27
01/27
NCT02520778: Osimertinib and Navitoclax in Treating Patients With EGFR-Positive Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer

Completed
1
27
US
Navitoclax, A-855071.0, ABT-263, BcI-2 Family Protein Inhibitor ABT-263, Osimertinib, AZD 9291, AZD-9291, AZD9291, Mereletinib
National Cancer Institute (NCI)
Advanced Lung Non-Squamous Non-Small Cell Carcinoma, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma, Stage III Lung Non-Small Cell Cancer AJCC v7, Stage IIIA Lung Non-Small Cell Cancer AJCC v7, Stage IIIB Lung Non-Small Cell Cancer AJCC v7, Stage IV Lung Non-Small Cell Cancer AJCC v7
10/22
12/23
NCT04041050: A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm

Active, not recruiting
1
85
Europe, Japan, US, RoW
Navitoclax, ABT-263, Ruxolitinib, Celecoxib, Celebrex
AbbVie
Myeloproliferative Neoplasm
12/26
12/26
NCT05455294: Combination Navitoclax, Venetoclax and Decitabine for Advanced Myeloid Neoplasms

Active, not recruiting
1
16
US
Navitoclax, ABT-263, Venetoclax, Venclexta, Decitabine, Dacogen
Jacqueline Garcia, MD, AbbVie
Myeloid Malignancy, Myelodysplastic Syndromes, Myelofibrosis, Acute Myeloid Leukemia, Myeloproliferative Neoplasm
12/25
12/26
22P.205, NCT05564650: Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome

Active, not recruiting
1
6
US
Navitoclax, 923564-51-6, A-855071.0, ABT-263, BcI-2 Family Protein Inhibitor ABT-263, Venetoclax, 1257044-40-8, 4-(4-((2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-N-((3-nitro-4-((tetrahydro-2H-pyran-4-ylmethyl)amino)phenyl)sulfonyl)-2-(1H-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide, ABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, Venclyxto, Decitabine, 2'-Deoxy-5-azacytidine, 2353-33-5, 4-Amino-1-(2-deoxy-beta-D-erythro-pentofuranosyl)-1,3,5-triazin-2(1H)-one, 5-Aza-2'-deoxycytidine, 5-Aza-2'deoxycytidine, 5-Aza-2-deoxycytidine, 5-Azadeoxycytidine, Dacogen, Decitabine for Injection, Deoxyazacytidine, Dezocitidine, Bone Marrow Biopsy, Biopsy of Bone Marrow, Biopsy, Bone Marrow, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Quality of Life Assessment
Thomas Jefferson University, AbbVie
Myelodysplastic Syndrome, Recurrent Myelodysplastic Syndrome, Refractory Myelodysplastic Syndrome
05/24
05/26
NCT06007911: Venetoclax-Navitoclax With Cladribine-based Salvage Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Withdrawn
1
36
US
Navitoclax Dose Level -1, ABT-263, Navitoclax Dose Level 0, Navitoclax Dose Level 1, Navitoclax Dose Level 2, Venetoclax Dose Level -1, Venclexta, Venetoclax Dose Levels 0 to 2, Cladribine, Mavenclad, Leustatin DSC, Cytarabine (Cladribine Low Dose Cytarabine Backbone), ara-C, Cytarabine (CLAG-M Backbone), Mitoxantrone, Novantrone, Granulocyte Colony-Stimulating Factor, G-CSF, filgrastim, Neupogen
Medical College of Wisconsin
Relapsed Adult AML, Refractory AML
12/25
04/27

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