drugset / Trial / NCT00849654
Study of the Safety and Tolerability of PCI-32765 in Patients With Recurrent B Cell Lymphoma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to establish the safety and optimal dose of orally administered PCI-32765 in patients with recurrent B cell lymphoma.
Timeline
- Start
- 2009-02
- Primary completion
- 2012-07
- Completion
- 2012-07
Publications
- Wilson WH, Young RM, Schmitz R, Yang Y, Pittaluga S, Wright G, Lih CJ, Williams PM, Shaffer AL, Gerecitano J, de Vos S, Goy A, Kenkre VP, Barr PM, Blum KA, Shustov A, Advani R, Fowler NH, Vose JM, Elstrom RL, Habermann TM, Barrientos JC, McGreivy J, Fardis M, Chang BY, Clow F, Munneke B, Moussa D, Beaupre DM, Staudt LM. Targeting B cell receptor signaling with ibrutinib in diffuse large B cell lymphoma. Nat Med. 2015 Aug;21(8):922-6. doi: 10.1038/nm.3884. Epub 2015 Jul 20.
- Marostica E, Sukbuntherng J, Loury D, de Jong J, de Trixhe XW, Vermeulen A, De Nicolao G, O'Brien S, Byrd JC, Advani R, McGreivy J, Poggesi I. Population pharmacokinetic model of ibrutinib, a Bruton tyrosine kinase inhibitor, in patients with B cell malignancies. Cancer Chemother Pharmacol. 2015 Jan;75(1):111-21. doi: 10.1007/s00280-014-2617-3. Epub 2014 Nov 8.
- Advani RH, Buggy JJ, Sharman JP, Smith SM, Boyd TE, Grant B, Kolibaba KS, Furman RR, Rodriguez S, Chang BY, Sukbuntherng J, Izumi R, Hamdy A, Hedrick E, Fowler NH. Bruton tyrosine kinase inhibitor ibrutinib (PCI-32765) has significant activity in patients with relapsed/refractory B-cell malignancies. J Clin Oncol. 2013 Jan 1;31(1):88-94. doi: 10.1200/JCO.2012.42.7906. Epub 2012 Oct 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibrutinib | Small molecule | 1.25 mg/kg | Oral |
| Subject | Ibrutinib | Small molecule | 2.5 mg/kg | Oral |
| Subject | Ibrutinib | Small molecule | 5 mg/kg | Oral |
| Subject | Ibrutinib | Small molecule | 8.3 mg/kg | Oral |
| Subject | Ibrutinib | Small molecule | 12.5 mg/kg | Oral |
| Subject | Ibrutinib | Small molecule | 17.5 mg/kg | Oral |
| Subject | Ibrutinib | Small molecule | 560 mg | Oral |