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

February 21, 2020 updated by: Novartis Pharmaceuticals

A Phase Ib Dose Escalation Study of BCL201 in Combination With Idelalisib in Patients With Follicular Lymphoma (FL) and Mantle Cell Lymphoma (MCL)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • Novartis Investigative Site
  • France
      • Pierre Benite Cedex, France, 69495
        • Novartis Investigative Site
      • Toulouse Cedex 9, France, 31059
        • Novartis Investigative Site
  • Germany
      • Freiburg, Germany, 79106
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Novartis Investigative Site
  • United States
    • New York
      • New York, New York, United States, 10017
        • Novartis Investigative Site
    • Texas
      • Houston, Texas, United States, 77030
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Follicular lymphoma (FL)
Drug: Idelalisib
Other Names:
  • Idela
Drug: BCL201
Other Names:
  • S55746
Experimental: Mantle cell lymphoma (MCL)
Drug: Idelalisib
Other Names:
  • Idela
Drug: BCL201
Other Names:
  • S55746

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of Response (DOR)
Time Frame: 24 months
24 months
Incidence rate of dose limiting toxicities (DLTs)
Time Frame: 24 months
24 months
Exposure to BCL201 and idelalisib as measured by AUC0-24h at C1D15
Time Frame: Cycle = 28 days
Cycle = 28 days
Plasma concentration of BCL201, idelalisib and GS-563117 (metabolite of idelalisib)
Time Frame: 24 Months
24 Months
AUC pharmacokinetics (PK) parameter for BCL201, idelalisib and GS-563117
Time Frame: 24 months
24 months
Objective Response Rate (ORR)
Time Frame: 24 months
24 months
Best Overall Response (BOR)
Time Frame: 24 months
24 months
Complete Response (CR)
Time Frame: 24 months
24 months
Partial Response (PR)
Time Frame: 24 months
24 months
Stable disease (SD)
Time Frame: 24 months
24 months
Cmax pharmacokinetics (PK) parameter for BCL201, idelalisib and GS-563117
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2015

Primary Completion (Actual)

July 10, 2018

Study Completion (Actual)

July 10, 2018

Study Registration Dates

First Submitted

October 8, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Actual)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBCL201X2102C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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