The DOI matches its Crossref record; 21 of the 21 references it cites were found in a registry or an index.
Phase 0 Clinical Trial of the Poly (ADP-Ribose) Polymerase Inhibitor ABT-888 in Patients With Advanced Malignancies
Open accessAbstract
Purpose: We conducted the first phase 0 clinical trial in oncology of a therapeutic agent under the Exploratory Investigational New Drug Guidance of the US Food and Drug Administration. It was a first-in-human study of the poly (ADP-ribose) polymerase (PARP) inhibitor ABT-888 in patients with advanced malignancies. Patients and Methods: ABT-888 was administered as a single oral dose of 10, 25, or 50 mg to determine the dose range and time course over which ABT-888 inhibits PARP activity in tumor samples and peripheral blood mononuclear cells, and to evaluate ABT-888 pharmacokinetics. Blood samples and tumor biopsies were obtained pre- and postdrug administration for evaluation of PARP activity and pharmacokinetics. A novel statistical approach was developed and utilized to study pharmacodynamic modulation as the primary end point for trials of limited sample size. Results: Thirteen patients with advanced malignancies received the study drug; nine patients underwent paired tumor biopsies. ABT-888 demonstrated good oral bioavailability and was well tolerated. Statistically significant inhibition of poly (ADP-ribose) levels was observed in tumor biopsies and peripheral blood mononuclear cells at the 25-mg and 50-mg dose levels. Conclusion: Within 5 months of study activation, we obtained pivotal biochemical and pharmacokinetic data that have guided the design of subsequent phase I trials of ABT-888 in combination with DNA-damaging agents. In addition to accelerating the development of ABT-888, the rapid conclusion of this trial demonstrates the feasibility of conducting proof-of-principle phase 0 trials as part of an alternative paradigm for early drug development in oncology.
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Cites
Can the pharmaceutical industry reduce attrition rates?
Kola, I., & Landis, J. (2004) · Nature Reviews Drug Discovery · doi:10.1038/nrd1470 · Cited by 4,167
Poly(ADP-ribose): novel functions for an old molecule
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Requirement of poly(ADP-ribose) polymerase in recovery from DNA damage in mice and in cells
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Poly(ADP-ribose) polymerase and the therapeutic effects of its inhibitors
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Donawho, C. K., Luo, Y., Luo, Y., Penning, T. D., Bauch, J. L., Bouska, J. J., Bontcheva-Diaz, V. D., Cox, B. F., DeWeese, T. L., Dillehay, L. E., et al. (2007) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-06-3039 · Cited by 773
Self-citationCurrent Development of Clinical Inhibitors of Poly(ADP-Ribose) Polymerase in Oncology
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Self-citationAlbert, J. M., Cao, C., Kim, K. W., Willey, C. D., Geng, L., Xiao, D., Wang, H., Sandler, A., Johnson, D. H., Colevas, A. D., et al. (2007) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-06-2872 · Cited by 266
Self-citationCompressing drug development timelines in oncology using phase '0' trials
Kummar, S., Kinders, R., Rubinstein, L., Parchment, R. E., Murgo, A. J., Collins, J., Pickeral, O., Low, J., Steinberg, S. M., Gutierrez, M., et al. (2007) · Nature Reviews Cancer · doi:10.1038/nrc2066 · Cited by 213
Self-citationChemopotentiation by PARP inhibitors in cancer therapy
Tentori, L., & Graziani, G. (2005) · Pharmacological Research · doi:10.1016/j.phrs.2005.02.010 · Cited by 192
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Murai, J., Huang, S.-Y. N., Renaud, A., Zhang, Y., Ji, J., Takeda, S., Morris, J., Teicher, B., Doroshow, J. H., & Pommier, Y. (2014) · Molecular Cancer Therapeutics · doi:10.1158/1535-7163.mct-13-0803 · Cited by 756
Self-citationDelivering affordable cancer care in high-income countries
Sullivan, R., Peppercorn, J., Sikora, K., Zalcberg, J., Meropol, N. J., Amir, E., Khayat, D., Boyle, P., Autier, P., Tannock, I. F., et al. (2011) · The Lancet Oncology · doi:10.1016/s1470-2045(11)70141-3 · Cited by 718
PARP Inhibitors: Clinical Relevance, Mechanisms of Action and Tumor Resistance
Rose, M., Burgess, J. T., O’Byrne, K., Richard, D. J., & Bolderson, E. (2020) · Frontiers in Cell and Developmental Biology · doi:10.3389/fcell.2020.564601 · Cited by 719
Plummer, R., Jones, C., Middleton, M., Wilson, R., Evans, J., Olsen, A., Curtin, N., Boddy, A., McHugh, P., Newell, D., et al. (2008) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-08-1223 · Cited by 383
An update on PARP inhibitors—moving to the adjuvant setting
Sonnenblick, A., de Azambuja, E., Azim, H. A., & Piccart, M. (2015) · Nature Reviews Clinical Oncology · doi:10.1038/nrclinonc.2014.163 · Cited by 373
Metadata
- Authors
- Kummar, S., Kinders, R., Gutierrez, M. E., Rubinstein, L., Parchment, R. E., Phillips, L. R., Ji, J., Monks, A., Low, J. A., Chen, A., Murgo, A. J., Collins, J., Steinberg, S. M., Eliopoulos, H., Giranda, V. L., Gordon, G., Helman, L., Wiltrout, R., Tomaszewski, J. E., & Doroshow, J. H.
- Venue
- Journal of Clinical Oncology
- Published
- 2009-06-01
- Volume
- 27
- Issue
- 16
- Pages
- 2705-2711
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2118682535
- Cited by
- 326
- References
- 21
- FWCI
- 15.66
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Kummar, S., Kinders, R., Gutierrez, M. E., Rubinstein, L., Parchment, R. E., Phillips, L. R., Ji, J., Monks, A., Low, J. A., Chen, A., Murgo, A. J., Collins, J., Steinberg, S. M., Eliopoulos, H., Giranda, V. L., Gordon, G., Helman, L., Wiltrout, R., Tomaszewski, J. E., & Doroshow, J. H. (2009). Phase 0 Clinical Trial of the Poly (ADP-Ribose) Polymerase Inhibitor ABT-888 in Patients With Advanced Malignancies. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2008.19.7681
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
