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BTK inhibitor PCI-32765 · 1 trial · 10 indications
MTD is defined as the highest dose Level at which =\< 1 of 6 patients experienced a DLT.
| Arm | Type | Description |
|---|---|---|
| Treatment (enzyme inhibitor, chemo, monoclonal antibody) | EXPERIMENTAL | Patients receive BTK inhibitor PCI-32765 PO QD on days 1-28. Patients also receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may continue receiving BTK inhibitor PCI-32765 PO in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| BTK inhibitor PCI-32765 | DRUG | Given PO |
| rituximab | BIOLOGICAL | Given IV |
| bendamustine hydrochloride | DRUG | Given IV |
| pharmacogenomic studies | OTHER | Correlative studies |
| pharmacological study | OTHER | Correlative studies |
| laboratory biomarker analysis | OTHER | Correlative studies |
Inclusion Criteria: * Histologically confirmed B-cell NHL of the following subtypes: follicular, marginal zone (nodal, splenic, or extranodal), Waldenstrom's macroglobulinemia, diffuse large B-cell (DLCL) or mantle cell lymphoma (MCL) according to 2008 World Health Organization (WHO) criteria that ...
BTK inhibitor PCI-32765 is being studied for the treatment of extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, as well as other B-cell lymphomas including nodal marginal zone lymphoma, recurrent diffuse large cell lymphoma, and recurrent mantle cell lymphoma. It is an investigational small molecule in Phase 1 clinical development.
BTK inhibitor PCI-32765 targets Bruton's tyrosine kinase (BTK), an enzyme involved in B-cell receptor signaling. By inhibiting BTK, the drug aims to disrupt the survival and proliferation of malignant B-cells in certain lymphomas. It is being evaluated in patients with marginal zone lymphoma and other B-cell malignancies.
BTK inhibitor PCI-32765 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is currently in Phase 1 clinical trials for the treatment of B-cell lymphomas.
BTK inhibitor PCI-32765 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants, with a planned enrollment of 48 patients.
BTK inhibitor PCI-32765 is being evaluated in clinical trial NCT01479842, titled 'Rituxan/Bendamustine/PCI-32765 in Relapsed DLBCL, MCL, or Indolent Non-Hodgkin's Lymphoma.' This Phase 1 study is active but not recruiting, with 48 participants enrolled in the United States. The trial is uncontrolled and not blinded.
BTK inhibitor PCI-32765 is also known as ibrutinib, a Bruton's tyrosine kinase inhibitor. It is being developed by AbbVie Inc. for the treatment of B-cell lymphomas, including extranodal marginal zone lymphoma. The drug is currently in Phase 1 clinical trials.