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Study of Safety and Efficacy of BCL201 and Idelalisib in Patients With FL and MCL

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ClinicalTrials.gov Identifier: NCT02603445
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

This is a phase Ib multi-center, open-label study: escalation part followed by expansion part. The primary purpose of the Phase Ib CBCL201X2102C study is to characterize the safety and tolerability of BCL201 combined with idelalisib in patients with FL and MCL.

Approximately 65 patients are to be enrolled.

The primary endpoint for the Phase Ib is frequency, severity and seriousness of AEs, lab abnormalities and other safety parameters such as ECG changes. An adaptive Bayesian logistic regression model (BLRM) will guide the dose escalation to determine the MTD/RDE in phase Ib. In addition Bayesian regression models will be used to estimate the dose-exposure relationships for both BCL201 and idelalisib in order to guide the escalation steps. A Bayesian method for the expansion part will be used for the primary activity objective.

The study data will be analyzed and reported based on all patients' data of the escalation and expansion part.


Condition or disease Intervention/treatment Phase
Follicular Lymphoma, Mantle Cell Lymphoma Drug: BCL201 Drug: Idelalisib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib Dose Escalation Study of BCL201 in Combination With Idelalisib in Patients With Follicular Lymphoma (FL) and Mantle Cell Lymphoma (MCL)
Actual Study Start Date : November 16, 2015
Actual Primary Completion Date : July 10, 2018
Actual Study Completion Date : July 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Idelalisib

Arm Intervention/treatment
Experimental: Follicular lymphoma (FL) Drug: BCL201
Other Name: S55746

Drug: Idelalisib
Other Name: Idela

Experimental: Mantle cell lymphoma (MCL) Drug: BCL201
Other Name: S55746

Drug: Idelalisib
Other Name: Idela




Primary Outcome Measures :
  1. Number of participants with adverse events (AEs) [ Time Frame: 24 months ]
    Characterized by Frequency, severity and seriousness of AEs, lab abnormalities and other safety parameters such as electrocardiogram (ECG) changes


Secondary Outcome Measures :
  1. Incidence rate of dose limiting toxicities (DLTs) [ Time Frame: 24 months ]
  2. Exposure to BCL201 and idelalisib as measured by AUC0-24h at C1D15 [ Time Frame: Cycle = 28 days ]
  3. Plasma concentration of BCL201, idelalisib and GS-563117 (metabolite of idelalisib) [ Time Frame: 24 Months ]
  4. AUC pharmacokinetics (PK) parameter for BCL201, idelalisib and GS-563117 [ Time Frame: 24 months ]
  5. Objective Response Rate (ORR) [ Time Frame: 24 months ]
  6. Best Overall Response (BOR) [ Time Frame: 24 months ]
  7. Duration of Response (DOR) [ Time Frame: 24 months ]
  8. Complete Response (CR) [ Time Frame: 24 months ]
  9. Partial Response (PR) [ Time Frame: 24 months ]
  10. Stable disease (SD) [ Time Frame: 24 months ]
  11. Cmax pharmacokinetics (PK) parameter for BCL201, idelalisib and GS-563117 [ Time Frame: 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of FL or MCL according to WHO 2008
  • Relapsed or refractory with at least one (FL) or two (MCL), but not more than four, prior lines of antineoplastic regimens.
  • Either FDG-avid on FDG-PET or measurable disease by CT on cross sectional imaging: > 1.5 cm for nodal lesion, > 1.0 cm for extra nodal lesion.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Exclusion Criteria:

  • For dose escalation part: Patients with MCL at high risk for tumor lysis syndrome
  • Prior treatment with PI3Kδ or Bcl-2 inhibitors.
  • Any other malignant disease
  • History of serious allergic reactions including anaphylaxis and toxic epidermal necrolysis
  • Inadequate organ function
  • Concomitant treatment with:
  • Strong CYP3A4/5 inducers or inhibitors
  • Sensitive CYP3A4/5 substrates or CYP3A4/5 substrates with narrow therapeutic index (NTI)
  • Sensitive CYP2D6 substrates or CYP2D6 substrates with NTI
  • Selected dual substrates of CYP3A4/5 and CYP2C8
  • Selected dual substrates of CYP3A4/5 and CYP2D6
  • Selected dual substrates of OATP and CYP450
  • Selected dual substrates of CYP3A4/5 and P-gp
  • NTI P-gp substrates
  • QT prolonging drugs with a known risk to induce TdP
  • Proton pump inhibitors
  • Treatment by warfarin or equivalent vitamin K antagonists.
  • Other investigational therapies
  • Herbal preparations/ medications
  • Grapefruit, Seville oranges or products containing either juice

Other protocol-defined inclusion/exclusion may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603445


Locations
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United States, New York
Novartis Investigative Site
New York, New York, United States, 10017
United States, Texas
Novartis Investigative Site
Houston, Texas, United States, 77030
Austria
Novartis Investigative Site
Salzburg, Austria, 5020
France
Novartis Investigative Site
Pierre-Benite Cedex, France, 69495
Novartis Investigative Site
Toulouse Cedex 9, France, 31059
Germany
Novartis Investigative Site
Freiburg, Germany, 79106
Novartis Investigative Site
Mainz, Germany, 55131
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02603445     History of Changes
Other Study ID Numbers: CBCL201X2102C
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
BCL201
idelalisib
Follicular lymphoma
FL
mantle cell lymphoma
MCL
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Idelalisib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action