Dasatinib in previously treated metastatic colorectal cancer: a phase II trial of the University of Chicago Phase II Consortium
Open accessAbstract
Background Treatment options for metastatic colorectal cancer (CRC) are limited after a fluoropyrimidine, oxaliplatin and irinotecan; novel agents need to be explored in this setting. Dasatinib, an oral inhibitor of Src family kinases, inhibits proliferation in CRC cell lines and has antitumor activity in CRC xenograft models.Patients and methods We conducted a multi-center phase II trial of dasatinib in unresectable, previously-treated metastatic CRC patients. No more than 2 prior chemotherapy regimens were permitted, which must have contained a fluoropyrimidine, oxaliplatin and irinotecan. The primary endpoint was progression-free survival (PFS) at 4 months. The Simon two-stage design required that at least 5 of the first 19 patients be progression-free at 4 months to expand to a second stage.Results Nineteen patients enrolled at 9 centers. The study was terminated after the first stage due to lack of efficacy. There were no objective responses; 1 patient (5%) had stable disease for 7.3 months. The PFS rate at 4 months was 5.3% (90% CI: 0.3, 22.6). Median PFS was 1.6 months (90% CI: 1.4, 1.8). Median overall survival was 5.1 months (90% CI: 2.4, 6.3). Grade 3/4 toxicities included fatigue in 16% of patients, and anemia, anorexia, nausea/vomiting and dyspnea in 11%.Conclusion Dasatinib is inactive as a single agent in previously treated metastatic CRC patients.
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Evaluation of dasatinib as a single agent in small cohorts of molecularly unselected, refractory metastatic CRC patients failed to show clinically meaningful results in clinical trials.
“Despite this antitumor effect observed in vitro, the evaluation of dasatinib as a single agent in small cohorts of molecularly unselected, refractory metastatic CRC patients failed to show clinically meaningful results in clinical trials [40].”
From Co-targeting SRC overcomes resistance to BRAF inhibitors in colorectal cancer (2025) · cites this paper as [40]
A phase II trial of dasatinib in 19 unresected and previously metastatic CRC patients was terminated due to lack of efficacy.
“a phase II trial of dasatinib in 19 unresected and previously metastatic CRC patients, who had undergone up to two prior regimens with fluoropyrimidine, oxaliplatin and irinotecan, was terminated due to lack of efficacy.83”
From The molecular rationale of Src inhibition in colorectal carcinomas (2014) · cites this paper as [83]
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References 23 · Cited by 49
- Authors
- Sharma, M. R., Wroblewski, K., Polite, B. N., Knost, J. A., Wallace, J. A., Modi, S., Sleckman, B. G., Taber, D., Vokes, E. E., Stadler, W. M., & Kindler, H. L.
- Affiliations
- University of Chicago (US)
- Illinois CancerCare (US)
- New York Oncology Hematology (US)
- Corresponding author
- Kindler, Hedy L.
- ORCID
- Venue
- Investigational New Drugs
- Published
- 2011-05-07
- Volume
- 30
- Issue
- 3
- Pages
- 1211-1215
- ISSN
- 0167-6997 (ISSN-L)
- 1573-0646
- PMC
- PMC4317401
- OpenAlex
- W2041191688
- Cited by
- 49
- References
- 23
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 1 · 2023: 4 · 2022: 3 · 2021: 1 · 2020: 5 · 2018: 4 · 2017: 4 · 2016: 5 · 2015: 8 · 2014: 4 · 2013: 3 · 2012: 3
- FWCI
- 1.89
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- Locations
- Investigational New Drugs (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (n01cm62201-16-0-1)
- National Cancer Institute (N01 CM062201, N01 CM-62201)
- Topics
- Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
- Health Sciences › Medicine › Oncology › Colorectal Cancer Surgical Treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Cancer therapeutics and mechanisms
- Keywords
- dasatinib, metastatic colorectal cancer, Src family kinase inhibitor, previously treated patients, progression-free survival, overall survival, monotherapy, chemotherapy toxicity, Simon two-stage design
- MeSH terms
- Dasatinib, Adult, Aged, Aged, 80 and over, Female, Humans, Liver Neoplasms, Lung Neoplasms, Male, Middle Aged, Pyrimidines, Thiazoles, Colorectal Neoplasms, src-Family Kinases, Protein Kinase Inhibitors
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