SPARK - PCI-32765MCL2001

• Research type

  Research Study

• Full title

  A Phase 2, Multicenter, Single-Arm Study to Evaluate the Efficacy and Safety of Single-Agent Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects with Mantle Cell Lymphoma Who Progress after Bortezomib Therapy

• IRAS ID

  96145

• Contact name

  Simon Rule

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2012-000711-88

• ISRCTN Number

  n/a

• Research summary

  Ibrutinib (also referred to as PCI-32765 or JNJ 54179060) is a first-in-class selective, irreversible small molecular inhibitor of Bruton??s tyrosine kinase (BTK) currently being co-developed by Pharmacyclics, Inc and Janssen Research & Development, LLC (JRD) for the treatment of B-cell malignancies. Despite recent advances in the treatment of mantle cell lymphoma (MCL), it remains a serious and fatal malignancy for which there is an unmet medical need, particularly for those patients who relapse or become refractory to treatment. Bortezomib is the only approved agent in the US for patients who have received at least 1 prior therapy. Results from a Phase 1 study and ongoing Phase 2 study of ibrutinib in patients with relapsed and refractory MCL, including patients who have been previously treated with bortezomib, demonstrate promising early efficacy (eg, overall response rate [ORR] of approximately 70%). As an oral daily treatment, ibrutinib may offer a treatment option to this patient population with rare and lethal disease who do not have other available approved treatment options.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  12/LO/0979

• Date of REC Opinion

  2 Aug 2012

• REC opinion

  Further Information Favourable Opinion