A phase I clinical trial of navitoclax, a targeted high-affinity Bcl-2 family inhibitor, in combination with gemcitabine in patients with solid tumors
Abstract
Purpose To investigate the safety, optimal dosing, pharmacokinetics and clinical activity of a regimen of navitoclax (ABT-263) combined with gemcitabine in patients with solid tumors.Experimental design Patients with solid tumors for which gemcitabine was deemed an appropriate therapy were enrolled into one of two different dosing schedules (21-day dosing schedule: navitoclax administered orally on days 1-3 and 8-10,; and gemcitabine 1,000 mg/m(2) on days 1 and 8; 28-day dosing schedule: navitoclax administrated orally on days 1-3, 8-10, and 15-17; and gemcitabine 1,000 mg/m(2) on days 1, 8 and 15). Navitoclax doses were escalated from 150 to 425 mg. An expanded safety cohort was conducted for the 21-day dosing schedule at the maximum tolerated dose (MTD) of navitoclax.Results Forty-six patients were enrolled at three U.S. centers. The most common adverse events included: hematologic abnormalities (thrombocytopenia, neutropenia, and anemia), liver enzyme elevations (ALT and AST), and gastrointestinal disturbances (diarrhea, nausea, and vomiting). Dose-limiting toxicities (DLTs) observed in cycle 1 were grade 4 thrombocytopenia (2 patients), grade 4 neutropenia (1 patient), and grade 3 AST elevation (2 patients). The MTD of navitoclax was 325 mg co-administered with gemcitabine 1,000 mg/m(2) for the 21-day schedule. No clinically significant pharmacokinetic drug-drug interactions were observed. There were no objective responses. Stable disease, reported at the end of cycle 2, was the best response in 54 % of evaluable patients (n = 39).Conclusions The combination of navitoclax 325 mg with gemcitabine 1,000 mg/m(2) was generally well tolerated and exhibited a favorable safety profile in patients with advanced solid tumors.
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Some senolytics may cause severe reductions in platelets or neutrophils.
“Some studies have found that some senolytics may cause severe reductions in platelets or neutrophils [112, 113].”
From Modulation of fracture healing by senescence-associated secretory phenotype (SASP): a narrative review of the current literature (2024) · cites this paper as [113]
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Sensitivity profiling reveals consistent drug responses across preclinical neuroblastoma modelsPreprint
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Senescence-directed nanotherapy ameliorates fibrosis and overcomes immune exclusion in cancer
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Sensitivity and Resistance to BH3 Mimetics in Cancer Therapy
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- Authors
- Cleary, J. M., Lima, C. M. S. R., Hurwitz, H. I., Montero, A. J., Franklin, C., Yang, J., Graham, A., Busman, T., Mabry, M., Holen, K., Shapiro, G. I., & Uronis, H.
- Affiliations
- Brigham and Women's Hospital (US)
- University of Miami (US)
- Duke Medical Center (US)
- Cleveland Clinic (US)
- AbbVie (United States) (US)
- Corresponding author
- Shapiro, Geoffrey I.
- ORCID
- Venue
- Investigational New Drugs
- Published
- 2014-06-11
- Volume
- 32
- Issue
- 5
- Pages
- 937-945
- ISSN
- 0167-6997 (ISSN-L)
- 1573-0646
- OpenAlex
- W2073638417
- Cited by
- 80
- References
- 22
- Citations by year
- 2026: 10 · 2025: 8 · 2024: 6 · 2023: 10 · 2022: 10 · 2021: 6 · 2020: 7 · 2019: 4 · 2018: 2 · 2017: 4 · 2016: 3 · 2015: 9 · 2014: 1
- FWCI
- 2.46
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- Investigational New Drugs (publishedVersion)
- PubMed (publishedVersion)
- Funders
- AbbVie
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Cell death mechanisms and regulation
- Health Sciences › Medicine › Oncology › Cancer-related Molecular Pathways
- Health Sciences › Medicine › Hematology › Acute Myeloid Leukemia Research
- Keywords
- navitoclax, BCL-2 inhibitor, gemcitabine, combination chemotherapy, solid tumors, maximum tolerated dose, dose-limiting toxicity, hematologic toxicity, thrombocytopenia, neutropenia, pharmacokinetics, drug-drug interactions
- MeSH terms
- Gemcitabine, Adult, Aged, Aged, 80 and over, Aniline Compounds, Antineoplastic Combined Chemotherapy Protocols, Deoxycytidine, Female, Humans, Male, Middle Aged, Neoplasms, Sulfonamides, Treatment Outcome, Proto-Oncogene Proteins c-bcl-2, Maximum Tolerated Dose
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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