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Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With RR DLBCL, Including Patients With MYC Alterations

This study is currently recruiting participants.
Verified April 2017 by Curis, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02674750
First Posted: February 4, 2016
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Curis, Inc.
  Purpose
This is a Phase 2, open-label, multicenter trial designed to evaluate the efficacy and safety of CUDC-907 in subjects 18 years and older with Relapsed/Refractory (RR) MYC-altered Diffuse Large B-Cell Lymphoma (DLBCL).

Condition Intervention Phase
Relapsed and/or Refractory Diffuse Large B-cell Lymphoma Including With Myc Alterations Drug: CUDC-907 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma, Including Patients With MYC Alterations

Resource links provided by NLM:


Further study details as provided by Curis, Inc.:

Primary Outcome Measures:
  • The efficacy of CUDC-907 in terms of objective response rate (ORR) [ Time Frame: 2 Years ]
    Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered Diffuse Large B-Cell Lymphoma (DLBCL)


Secondary Outcome Measures:
  • The efficacy of CUDC-907 in terms of progression-free survival (PFS) [ Time Frame: 2 Years ]
    Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered DLBCL

  • To evaluate in terms of progression-free survival at 6 months (PFS6) [ Time Frame: 2 years ]
    Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered DLBCL

  • To evaluate overall survival (OS) [ Time Frame: 2 years ]
    Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered DLBCL

  • To evaluate the disease control rate (DCR) [ Time Frame: 2 years ]
    Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered DLBCL

  • To evaluate the duration of response (DOR) [ Time Frame: 2 years ]
    Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered DLBCL

  • To evaluate the incidence and severity of adverse events (AEs), serious adverse events (SAEs), and other safety parameters in subjects receiving CUDC-907 [ Time Frame: 2 years ]
    Safety of CUDC-907 in subjects with Relapsed/Refractory DLBCL


Estimated Enrollment: 200
Study Start Date: January 2016
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CUDC-907
RR-DLBCL, including with MYC alterations detected by FISH or by >=40% MYC by IHC
Drug: CUDC-907

Detailed Description:

Patients with RR DLBCL will be eligible for treatment with CUDC-907, as long as they have tumor tissue available that can be tested for MYC-altered disease based on one of the following:

  • Fresh tumor tissue obtained from biopsy accessible lesions , or
  • Archived tumor tissue (most recent available)

Subjects will be required to submit archival tumor samples (most recent available) or fresh tumor samples for central FISH and IHC testing. Subjects whose tumors have been previously characterized as MYC-altered are strongly encouraged to enter the study. For subjects who enter the study with unconfirmed MYC-altered disease, fresh tumor samples are preferred.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. At least 2 but no more than 4 prior lines of therapy for the treatment of de novo DLBCL and ineligible for (or failed) autologous or allogeneic stem cell transplant (SCT) (salvage therapy, conditioning therapy and maintenance with transplant will be considered one prior treatment). NOTE: For follicular lymphoma transformed to DLBCL (t-FL/DLBCL), single agent non-cytotoxic therapy will not be considered as a line of therapy.
  3. Histopathologically confirmed diagnosis of one of the following:

    • RR DLBCL per the 2008 World Health Organization (WHO) classification of hematopoietic and lymphoid tumors (Swerdlow et al, 2008).
    • High grade B-cell lymphoma (HGBL), with MYC and BCL2 and/or BCL6 rearrangements or DLBCL, NOS per the 2016 revision of the WHO classification of lymphoid neoplasms (Swerdlow et al, 2016).
    • Diagnosis of t-FL/DLBCL is allowed. However, other B-cell lymphomas including other transformed indolent lymphomas/DLBCL per the 2008 WHO classification, and Burkitt lymphoma are not eligible.

Exclusion Criteria:

  1. Known primary mediastinal, ocular, epidural, testicular or breast DLBCL.
  2. Active CNS involvement of their malignancy.
  3. Known allergy or hypersensitivity to phosphatidylinositol 3 kinase (PI3K) inhibitors or any component of the formulations used in this study.
  4. Cytotoxic anticancer therapy (e.g., alkylating agents, anti-metabolites, purine analogues) or any other systemic anticancer therapy within 2 weeks of study entry.
  5. Radiotherapy delivered to non-target lesions within one week prior to starting study treatment or delivered to target lesions that will be followed on the study (note: prior sites of radiation will be recorded).
  6. Treatment with experimental therapy within 5 terminal half-lives (t1/2) or 4 weeks prior to enrollment, whichever is longer.
  7. Current or planned glucocorticoid therapy, with the following exceptions:

    • Doses ≤ 10 mg/kg/day prednisolone or equivalent is allowed, provided that the steroid dose has been stable or tapering for at least 14 days prior to the first dose of CUDC-907.
    • Inhaled, intranasal, intraarticular, and topical steroids are permitted.
  Contacts and Locations
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): NCT02674750


Contacts
Contact: Amir Hafeez, MD clinicaltrials@curis.com

  Show 25 Study Locations
Sponsors and Collaborators
Curis, Inc.
  More Information

Responsible Party: Curis, Inc.
ClinicalTrials.gov Identifier: NCT02674750     History of Changes
Other Study ID Numbers: CUDC-907-201
First Submitted: January 29, 2016
First Posted: February 4, 2016
Last Update Posted: April 4, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Curis, Inc.:
DLBCL
MYC

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin