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

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: No masking 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:

MedlinePlus related topics: Lymphoma

Genetic and Rare Diseases Information Center resources: Lymphosarcoma B-cell Lymphoma Diffuse Large B-Cell Lymphoma

U.S. FDA Resources

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


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

Criteria

Inclusion Criteria:

Age ≥ 18 years.
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.
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:

Known primary mediastinal, ocular, epidural, testicular or breast DLBCL.
Active CNS involvement of their malignancy.
Known allergy or hypersensitivity to phosphatidylinositol 3 kinase (PI3K) inhibitors or any component of the formulations used in this study.
Cytotoxic anticancer therapy (e.g., alkylating agents, anti-metabolites, purine analogues) or any other systemic anticancer therapy within 2 weeks of study entry.
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).
Treatment with experimental therapy within 5 terminal half-lives (t1/2) or 4 weeks prior to enrollment, whichever is longer.
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	January 29, 2016
Last Updated:	April 3, 2017
Individual Participant Data
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

ClinicalTrials.gov processed this record on June 22, 2017