Drugs / Navitoclax
Trials 43
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 122 trials | ||||||
| Phase 1 | NCT06007911 | Aug 2024 → Dec 2025 | acute myeloid leukemia | Medical College of Wisconsin | Withdrawn | No outcome recorded |
| Phase 1 | NCT05564650 | Jan 2023 → May 2024 | myelodysplastic syndrome | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 1 | NCT05358639 | Nov 2022 → Mar 2025 overdue | ovarian serous adenocarcinoma, triple-negative breast carcinoma | Sunnybrook Health Sciences Centre | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05222984 | Jul 2022 → Mar 2027 expected | acute myeloid leukemia | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05455294 | Jul 2022 → Apr 2024 overdue | acute myeloid leukemia, myelodysplastic syndrome, myelofibrosis | Jacqueline Garcia, MD | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04480086 | Mar 2021 → Jul 2023 | myelofibrosis | AbbVie | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04454658 | Nov 2020 → Jan 2027 expected | myelofibrosis | AbbVie | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04041050 | Nov 2019 → Dec 2026 expected | myeloproliferative neoplasm | AbbVie | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03181126 | Nov 2017 → Nov 2020 | acute lymphoblastic leukemia, lymphoblastic lymphoma | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT02520778 | Aug 2016 → Oct 2022 | non-small cell lung carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT02143401 | Jan 2015 → Nov 2022 | cirrhosis of liver, hepatitis B virus infection, hepatitis C virus infection, hepatocellular carcinoma +1 | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT01121133 | May 2010 → May 2011 | cancer, lymphoma | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT01021358 | Jan → Oct 2010 | B-cell chronic lymphocytic leukemia, cancer | Abbott | Completed | No outcome recorded |
| Phase 1 | NCT00878449 | Oct 2009 → Jul 2011 | cancer | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT01053520 | Oct → Dec 2009 | — | Abbott | Completed | No outcome recorded |
| Phase 1 | NCT00982566 | Oct 2009 → Oct 2010 | cancer, lymphoid hemopathy | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT01009073 | Oct 2009 → Jun 2013 | cancer | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT00887757 | Sep 2009 → Nov 2011 | cancer | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT00788684 | Jul 2009 → Feb 2025 | lymphoid leukemia, neoplasm of mature B-cells, non-Hodgkin lymphoma | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT00888108 | Jul 2009 → Mar 2012 | cancer | Abbott | Completed | No outcome recorded |
| Phase 1 | NCT00891605 | Jul 2009 → Jul 2012 | cancer | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT00743028 | Aug 2008 → Aug 2010 | B-cell chronic lymphocytic leukemia | Abbott | Completed | No outcome recorded |
| Phase 1/29 trials | ||||||
| Phase 1/2 | NCT05740449 | Oct 2023 → Oct 2029 | T-lymphoblastic lymphoma, acute lymphoblastic leukemia | Princess Maxima Center for Pediatric Oncology | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05192889 | Aug 2022 → Jun 2024 overdue | acute lymphoblastic leukemia | St. Jude Children's Research Hospital | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05054465 | Oct 2021 → Aug 2025 overdue | acute lymphoblastic leukemia | Israeli Medical Association | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT03366103 | Mar 2018 → Jul 2021 | metastatic malignant neoplasm, small cell lung carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1/2 | NCT02079740 | Mar 2014 → Dec 2022 overdue | metastatic malignant neoplasm, refractory malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT01989585 | Mar 2014 → Dec 2027 expected | cutaneous melanoma, metastatic melanoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT00481091 | Jul 2007 → May 2022 | B-cell chronic lymphocytic leukemia | AbbVie | Completed | No outcome recorded |
| Phase 1/2 | NCT00445198 | Apr 2007 → Dec 2010 | small cell lung carcinoma | AbbVie | Completed | No outcome recorded |
| Phase 1/2 | NCT00406809 | Nov 2006 → Oct 2016 | follicular lymphoma, lymphoid leukemia, mantle cell lymphoma, peripheral T-cell lymphoma, not otherwise specified | AbbVie | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT06210750 | Aug 2024 → Sep 2026 | T-cell acute lymphoblastic leukemia, T-lymphoblastic lymphoma | National Cancer Institute (NCI) | Withdrawn | No outcome recorded |
| Phase 2 | NCT05864742 | Sep 2023 → Jun 2026 overdue | mantle cell lymphoma | Peter MacCallum Cancer Centre, Australia | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03222609 | Oct 2017 → Mar 2022 | myelofibrosis | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT02591095 | Jan 2016 → Apr 2017 | — | Centre Francois Baclesse | Completed | No outcome recorded |
| Phase 2 | NCT01828476 | Jun 2013 → Feb 2016 | prostate cancer | Rutgers, The State University of New Jersey | Terminated | No outcome recorded |
| Phase 2 | NCT01557777 | Jun 2012 → Jul 2013 | chronic lymphocytic leukemia/small lymphocytic lymphoma | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01423539 | Oct 2011 → Feb 2014 | diffuse large B-cell lymphoma | Genentech, Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT01087151 | Aug 2010 → Jun 2012 | B-cell chronic lymphocytic leukemia | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00918450 | Mar 2010 → Dec 2012 | B-cell chronic lymphocytic leukemia | Abbott | Withdrawn | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT04472598 | Sep 2020 → Apr 2023 | myelofibrosis | AbbVie | Completed | Met primary |
| Phase 3 | NCT04468984 | Aug 2020 → Jan 2025 overdue | myelofibrosis | AbbVie | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05215405 | — | childhood acute lymphoblastic leukemia | Kathleen Ludwig | No longer available | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT00868413 Comparator | Nov 2009 → May 2013 | B-cell chronic lymphocytic leukemia | AbbVie | Completed | No outcome recorded |
| — | NCT03592576 Background | — | acute lymphoblastic leukemia, lymphoblastic lymphoma, myelofibrosis | AbbVie | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2022-12-10 | AbbVie | Results AbbVie Presents Data at the 64th American Society of Hematology (ASH) Annual Meeting for Investigational Navitoclax in Combination With Ruxolitinib for JAK Inhibitor-Naïve Myelofibrosis Patients abbvie.com ↗
The exploratory analysis suggests the combination of navitoclax and ruxolitinib led to reductions in bone marrow fibrosis (BMF) and variant allele frequency (VAF) for common genetic mutations found in individuals with myelofibrosis that may indicate potential disease modification. |
| 2022-11-22 | AbbVie | Results AbbVie Highlights Blood Cancer Data From Its Growing Oncology Pipeline at the 64th ASH Annual Meeting abbvie.com ↗
The Combination of Navitoclax and Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Mediates Responses Suggestive of Disease Modification |
| 2022-06-10 | AbbVie | Results AbbVie Presents Investigational Navitoclax Preliminary Data in JAK Inhibitor Naïve Myelofibrosis Patients abbvie.com ↗
AbbVie (NYSE: ABBV) today announced new data from Cohort 3 of its Phase 2 REFINE study of investigational navitoclax in combination with ruxolitinib in JAK inhibitor naïve patients with myelofibrosis (MF), a rare and difficult to treat blood cancer. |
| 2022-04-12 | AbbVie | Results AbbVie Presents Positive Investigational Navitoclax Combination Data in Phase 2 REFINE Study Suggesting Anti-Fibrosis Activity for Patients with Myelofibrosis abbvie.com ↗
AbbVie (NYSE: ABBV) today announced new data from a Phase 2 trial of navitoclax in combination with ruxolitinib in patients with myelofibrosis. |
| 2020-11-05 | AbbVie | Results AbbVie to Highlight Blood Cancer Leadership and Advancing Oncology Pipeline at the ASH 62ND Annual Meeting abbvie.com ↗
The Addition of Navitoclax to Ruxolitinib Demonstrates Efficacy Within Different High-Risk Populations in Patients with Relapsed/Refractory Myelofibrosis |
| 2015-06-15 | Oncolytics Biotech | Results Oncolytics Biotech® Inc. Collaborators Present REOLYSIN® Preclinical Data at the 9th International Conference on Oncolytic Virus Therapeutics oncolyticsbiotech.com ↗
They concluded that the combination of reovirus and ABT-263 could increase direct and immune-mediated killing of peripheral disease and that reovirus in combination with Fludarabine may be useful in targeting drug-resistant lymph node disease. |
All press releases naming this drug 6 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 49 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Navitoclax | “METHODS: We conducted a prospective multicenter single-arm phase II study to assess the efficacy of Navitoclax (orally available ABT-737 analogue) monotherapy in 46 heavily...” PMID 35123771 ↗ Feb 202232“Navitoclax, a novel BCL-2 and BCL-XL inhibitor, demonstrated promising antitumor activity in the dose-escalation part of a phase 1/2a study (NCT00406809) in lymphoid tumors.” PMID 33236943 ↗ Nov 2020 “Navitoclax and Abiraterone Acetate With or Without Hydroxychloroquine in Treating Patients With Progressive Metastatic Castrate Refractory Prostate Cancer” NCT01828476 ↗ “Phase I study of Navitoclax (ABT-263), a novel Bcl-2 family inhibitor, in patients with small-cell lung cancer and other solid tumors.” PMID 21282543 ↗ Jan 2011 “A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-263 (Navitoclax).” NCT01021358 ↗ “Navitoclax (ABT-263), a novel, oral Bcl-2 inhibitor” PMID 26420235 ↗ Sep 2015 |
| Known as | A-855071.0 | ChEMBL registry synonym — accepted as the source's own label CHEMBL443684 ↗ |
| Known as | A-855071.3 | ChEMBL registry synonym — accepted as the source's own label CHEMBL443684 ↗ |
| Known as | ABT-263 | “A phase II study of Navitoclax (ABT-263) as single agent in women heavily pretreated for recurrent epithelial ovarian cancer: The MONAVI - GINECO study.” PMID 35123771 ↗ Feb 202217“Phase I study of Navitoclax (ABT-263), a novel Bcl-2 family inhibitor, in patients with small-cell lung cancer and other solid tumors.” PMID 21282543 ↗ Jan 2011 “Assess the Oral Bioavailability of a New ABT-263 Formulation in Healthy Female Subjects” NCT01053520 ↗ “Navitoclax (ABT-263), a novel, oral Bcl-2 inhibitor” PMID 26420235 ↗ Sep 2015 |
| Known as | ABT-263, navitoclax | “ABT-263, navitoclax” NCT01121133 ↗ |
| Known as | NAVITOCLAX DIHYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL443684 ↗ |
| Action | Inhibit | “Navitoclax, a novel BCL-2 and BCL-XL inhibitor” PMID 33236943 ↗ Nov 20202“Apoptosis regulator Bcl-W inhibitor” CHEMBL443684 ↗ “Apoptosis regulator Bcl-X inhibitor” CHEMBL443684 ↗ |
| Modality | Small molecule | “Navitoclax, a first-in-class small molecule Bcl-2 family inhibitor” PMID 25047139 ↗ Jul 2014 |
| Route | Oral | “ABT-263: oral solution or tablets, once daily dosing until disease progression” NCT00788684 ↗ |
| Target | BCL2 | “specifically inhibits BCL2” PMID 22184378 ↗ Dec 2011 |
| Target | BCL2L1 | “Apoptosis regulator Bcl-X inhibitor” CHEMBL443684 ↗ |
| Target | BCL2L2-PABPN1 | “Apoptosis regulator Bcl-W inhibitor” CHEMBL443684 ↗ |