Clinical Trials

Navitoclax (ABT-263) has been evaluated in numerous clinical trials spanning Phase 1 through Phase 3, focusing on hematologic malignancies—such as myelofibrosis, acute lymphoblastic leukemia, and acute myeloid leukemia—and advanced solid tumors, including high-grade serous ovarian carcinoma. These protocols are sponsored by pharmaceutical companies like AbbVie, governmental organizations such as the National Cancer Institute, and academic research institutions. Their recruitment statuses vary across active recruitment, completed investigations, active non-recruiting cohorts, and terminated or withdrawn studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05740449 WITHDRAWN
Acute Lymphoblastic Leukemia, in Relapse; Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent; Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Recurrent; Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory; Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Refractory
Princess Maxima Center for Pediatric Oncology
 2023-10-01 PHASE1; PHASE2
NCT01989585 ACTIVE_NOT_RECRUITING
Clinical Stage III Cutaneous Melanoma AJCC v8; Clinical Stage IV Cutaneous Melanoma AJCC v8; Malignant Solid Neoplasm; Metastatic Melanoma; Unresectable Melanoma
National Cancer Institute (NCI)
 2014-03-24 PHASE1; PHASE2
NCT05222984 ACTIVE_NOT_RECRUITING
Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia
City of Hope Medical Center
 2022-07-29 PHASE1
NCT04454658 ACTIVE_NOT_RECRUITING
Myelofibrosis (MF)
AbbVie
 2020-11-11 PHASE1
NCT04041050 ACTIVE_NOT_RECRUITING
Myeloproliferative Neoplasm
AbbVie
 2019-11-08 PHASE1
NCT06210750 WITHDRAWN
T Acute Lymphoblastic Leukemia; T Lymphoblastic Lymphoma
National Cancer Institute (NCI)
 2024-08-09 PHASE2
NCT05864742 ACTIVE_NOT_RECRUITING
Mantle Cell Lymphoma Refractory
Peter MacCallum Cancer Centre, Australia
 2023-09-07 PHASE2
NCT06007911 WITHDRAWN
Relapsed Adult AML; Refractory AML
Medical College of Wisconsin
 2024-08-31 PHASE1
NCT05054465 UNKNOWN
Acute Lymphoblastic Leukemia
Israeli Medical Association
 2021-10-01 PHASE1; PHASE2
NCT05358639 ACTIVE_NOT_RECRUITING
High Grade Serous Carcinoma; Triple Negative Breast Cancer; Ovarian Cancer
Sunnybrook Health Sciences Centre
 2022-11-09 PHASE1
NCT00788684 COMPLETED
CD20-Positive Lymphoid Malignancies; Chronic Lymphoid Leukemia; Hematological Malignancies; Non-Hodgkin's Lymphoma
AbbVie
 2009-07-21 PHASE1
NCT04468984 ACTIVE_NOT_RECRUITING
Myelofibrosis (MF)
AbbVie
 2020-08-31 PHASE3
NCT05192889 ACTIVE_NOT_RECRUITING
Refractory Acute Lymphoblastic Leukemia; Relapsed Acute Lymphoblastic Leukemia
St. Jude Children's Research Hospital
 2022-08-25 PHASE1; PHASE2
NCT05564650 COMPLETED
Myelodysplastic Syndrome; Recurrent Myelodysplastic Syndrome; Refractory Myelodysplastic Syndrome
Thomas Jefferson University
 2023-01-12 PHASE1
NCT05455294 ACTIVE_NOT_RECRUITING
Myeloid Malignancy; Myelodysplastic Syndromes; Myelofibrosis; Acute Myeloid Leukemia; Myeloproliferative Neoplasm
Jacqueline Garcia, MD
 2022-07-18 PHASE1
NCT04480086 TERMINATED
Myelofibrosis (MF)
AbbVie
 2021-03-17 PHASE1
NCT04472598 COMPLETED
Myelofibrosis (MF)
AbbVie
 2020-09-29 PHASE3
NCT02079740 ACTIVE_NOT_RECRUITING
Metastatic Malignant Solid Neoplasm; Refractory Malignant Solid Neoplasm; Unresectable Malignant Solid Neoplasm
National Cancer Institute (NCI)
 2014-03-26 PHASE1; PHASE2
NCT02143401 COMPLETED
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
National Cancer Institute (NCI)
 2015-01-30 PHASE1
NCT05358639 Recruiting
High Grade Serous Carcinoma|Triple Negative Breast Cancer|Ovarian Cancer
Sunnybrook Health Sciences Centre|Exactis Innovation|Centre hospitalier de l''Université de Montréal (CHUM)|Princess Margaret Hospital Canada
 2022-11-09 Phase 1
NCT02520778 COMPLETED
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
National Cancer Institute (NCI)
 2016-08-30 PHASE1
NCT00481091 COMPLETED
Chronic Lymphocytic Leukemia
AbbVie
 2007-07-25 PHASE1; PHASE2
NCT03222609 COMPLETED
Myelofibrosis (MF)
AbbVie
 2017-10-31 PHASE2
NCT03366103 TERMINATED
Metastatic Malignant Solid Neoplasm; Recurrent Lung Small Cell Carcinoma; Recurrent Malignant Solid Neoplasm; Refractory Malignant Solid Neoplasm; Stage III Lung Small Cell Carcinoma, by American Joint Committee on Cancer (AJCC) v7; Stage IIIA Lung Small Cell Carcinoma AJCC v7; Stage IIIB Lung Small Cell Carcinoma AJCC v7; Stage IV Lung Small Cell Carcinoma AJCC v7; Unresectable Solid Neoplasm
National Cancer Institute (NCI)
 2018-03-20 PHASE1; PHASE2
NCT04480086 Terminated
Myelofibrosis (MF)
AbbVie
 2021-03-17 Phase 1
NCT03181126 COMPLETED
Acute Lymphoblastic Leukemia (ALL); Lymphoblastic Lymphoma
AbbVie
 2017-11-27 PHASE1
NCT04454658 Active not recruiting
Myelofibrosis (MF)
AbbVie
 2020-11-11 Phase 1
NCT02591095 COMPLETED
Platinum-resistant or Refractory Ovarian Cancer
Centre Francois Baclesse
 2016-01 PHASE2
NCT00406809 COMPLETED
Chronic Lymphoid Leukemia; Lymphoid Malignancies; Non-Hodgkin's Lymphoma; Follicular Lymphoma; Mantle Cell Lymphoma; Peripheral T-cell Lymphoma
AbbVie (prior sponsor, Abbott)
 2006-11 PHASE1; PHASE2
NCT01828476 TERMINATED
Prostate Cancer
Rutgers, The State University of New Jersey
 2013-06 PHASE2
NCT01423539 WITHDRAWN
Diffuse Large B-Cell Lymphoma
Genentech, Inc.
 2011-10 PHASE2
NCT01557777 COMPLETED
Chronic Lymphocytic Leukemia
AbbVie (prior sponsor, Abbott)
 2012-06 PHASE2
NCT01009073 COMPLETED
Solid Tumors
AbbVie (prior sponsor, Abbott)
 2009-10 PHASE1
NCT00868413 COMPLETED
Chronic Lymphocytic Leukemia
AbbVie (prior sponsor, Abbott)
 2009-11 PHASE1
NCT00918450 WITHDRAWN
B-cell Chronic Lymphocytic Leukemia
Abbott
 2010-03 PHASE2
NCT00891605 COMPLETED
Solid Tumors
AbbVie
 2009-07 PHASE1
NCT01087151 COMPLETED
Chronic Lymphocytic Leukemia
Genentech, Inc.
 2010-08 PHASE2
NCT00888108 COMPLETED
Solid Tumor
Abbott
 2009-07 PHASE1
NCT00887757 COMPLETED
Solid Tumors
AbbVie
 2009-09 PHASE1
NCT00878449 COMPLETED
Solid Tumors
AbbVie (prior sponsor, Abbott)
 2009-10 PHASE1
NCT01121133 COMPLETED
Lymphoma, Including Chronic Lymphocytic Leukemia; Solid Tumors
AbbVie
 2010-05 PHASE1
NCT00445198 COMPLETED
Small Cell Lung Cancer; Small Cell Lung Carcinoma
AbbVie (prior sponsor, Abbott)
 2007-04 PHASE1; PHASE2
NCT01021358 COMPLETED
Lymphoma; Chronic Lymphocytic Leukemia; Solid Tumors
Abbott
 2010-01 PHASE1
NCT00982566 COMPLETED
Lymphoid Malignancy; Solid Tumors
AbbVie
 2009-10 PHASE1
NCT00743028 COMPLETED
Chronic Lymphocytic Leukemia; Lymphomas; Leukemias
Abbott
 2008-08 PHASE1
NCT01053520 COMPLETED
Healthy Female Subjects
Abbott
 2009-10 PHASE1

(data from https://clinicaltrials.gov, updated on 2024-06-21)

Check the Navitoclax (ABT-263) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Navitoclax (ABT-263) functions as a potent inhibitor by selectively binding anti-apoptotic Bcl-2 family proteins—including Bcl-xL, Bcl-2, and Bcl-w—thereby neutralizing their prosurvival activity and inducing apoptotic cell death. By restoring apoptosis in tumor cells that overexpress these prosurvival factors, Navitoclax inhibits tumor proliferation and overcomes chemoresistance, providing therapeutic utility in clinical trial indications such as myelofibrosis, leukemia, and solid neoplasms.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.