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Ongoing Clinical Trials With Copanlisib

KEY

  • Phase I
  • Phase II
  • Phase III

DESCRIPTION

DISEASE OF INTEREST

Primary Outcome Measure:

  • Progression-free survival (PFS)

Secondary Outcome Measures:

  • Objective response rate (ORR), duration of response (DOR), complete response (CR), time to progression (TTP), overall survival (OS), quality of life (QoL), safety and tolerability

Selected Inclusion Criteria:

  • Age ≥18 years with histologically confirmed diagnosis of iNHL in CD20-positive patients (limited to: FL grades 1-2-3a, SLL, LPL/WM, MZL)
  • Relapsed after last rituximab-containing therapy (other previous lines after rituximab are allowed)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Availability of fresh tumor tissue and/or archival tumor tissue (obtained within 5 years of the consent date) at screening
  • Patients must either have:
    • Had a progression-free and treatment-free interval of ≥12 months after completion of the last rituximab-containing treatment OR
    • Been unfit for chemotherapy (eg, age, comorbidities, residual toxicities) with a progression-free and treatment-free interval of at least 6 months after completion of the last rituximab-containing treatment OR
    • Been unwilling to receive chemotherapy with a progression-free and treatment-free interval of at least 6 months after completion of the last rituximab-containing treatment

Selected Exclusion Criteria:

  • Histologically confirmed diagnosis of FL grade 3b, disease transformation, or CLL
  • Patients with HbA1c >8.5% at screening
  • Documented evidence of resistance to prior treatment with idelalisib or other PI3K inhibitors
  • Prior treatment with copanlisib
CLL, chronic lymphocytic leukemia; FL, follicular lymphoma; HbA1c, hemoglobin A1c; iNHL, indolent non-Hodgkin's lymphoma; LPL/WM, lymphoplasmacytic lymphoma/Waldenström's macroglobulinemia; MZL, marginal zone lymphoma; PD, progressive disease; PI3K, phosphatidylinositol-3-kinase; QW, once-weekly; SLL, small lymphocytic lymphoma.
Copanlisib is being investigated for uses that are not approved by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), or other health authorities.For complete information, please visit:
http://www.clinicaltrials.gov (NCT02367040).
*Patients who have had prior BR with relapse >24 months from last BR therapy are eligible to be enrolled in the BR arm again.

Primary Outcome Measures:

  • Safety run-in: Determination of the recommended Phase III dose of copanlisib in combination with standard immunochemotherapy, assessed by the occurrence of dose-limiting toxicities and adverse events
  • Phase III: To evaluate copanlisib in combination with standard immunochemotherapy, compared to placebo and standard immunotherapy, assessed by progression-free survival (PFS)

Secondary Outcome Measures:

  • Objective response rate (ORR), duration of response (DOR), complete tumor response rate (CRR), time to progression (TTP), overall survival (OS), quality of life (QoL), safety and tolerability

Selected Inclusion Criteria:

  • Patients ≥18 years with histologically confirmed diagnosis of CD20-positive indolent NHL (limited to: FL grades 1-2-3a, SLL, LPL/WM, MZL)
  • Relapsed after 1-3 prior lines of therapy, including rituximab-based immunochemotherapy and alkylating agents
  • Previous exposure to PI3K inhibitor is acceptable provided there is no resistance
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Availability of fresh tumor tissue and/or archival tumor tissue at screening

Selected Exclusion Criteria:

  • Histologically confirmed diagnosis of FL grade 3b, transformed disease, or CLL
  • Rituximab resistance at any line of therapy
  • Patients with HbA1c >8.5% at screening
  • Uncontrolled hypertension
BR, bendamustine plus rituximab; CLL, chronic lymphocytic leukemia; FL, follicular lymphoma; HbA1c, hemoglobin A1c; LPL/WM, lymphoplasmacytic lymphoma/Waldenström’s macroglobulinemia; MZL, marginal zone lymphoma; NHL, non-Hodgkin's lymphoma; PD, progressive disease; PI3K, phosphatidylinositol-3-kinase; R-B, rituximab in combination with bendamustine; R-CHOP, rituximab in combination with cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone; R-CVP, rituximab in combination with cyclophosphamide, vincristine and prednisone; SLL, small lymphocytic lymphoma.
Copanlisib is being investigated for uses that are not approved by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), or other health authorities. For complete information, please visit:
http://www.clinicaltrials.gov (NCT02626455).