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

NCT02674750 | Completed Phase 2 Results DMC

• 1 other identifier: CUDC-907-201
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 25

Brief Summary

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).

Conditions

Relapsed and/or Refractory Diffuse Large B-cell Lymphoma Including With Myc Alterations

Keywords

DLBCL; MYC

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered Diffuse Large B-Cell Lymphoma (DLBCL)

  2 Years

Secondary Outcomes (4)

• Median Progression-free Survival

  1 year

• Overall Survival (OS)

  1 year

• Disease Control Rate (DCR)

  1 year

• Number of Participants and Severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Safety Parameters

  AEs were collected for each participant for the duration that they remained on the study, on average of 4 months

Study Arms (3)

Group A

EXPERIMENTAL

Group A: MYC translocation+ and/or MYC gene copy number gain by FISH

Drug: CUDC-907

Group B

EXPERIMENTAL

Group B: MYC expression in \> 40% of tumor cells by IHC

Drug: CUDC-907

Group C

EXPERIMENTAL

Group C: MYC translocation- by FISH, and MYC expression in \< 40% of tumor cells, and no MYC gene copy number gain by FISH

Drug: CUDC-907

Interventions

CUDC-907 DRUG

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Curis, Inc.: lead

Study Sites (25)

University of California San Francisco-Fresno

Fresno, California, 93701, United States

Location

University of Southern California, Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

University of Chicago

Chicago, Illinois, 60647, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Rochester

Rochester, New York, 55905, United States

Location

University of Oklahoma Health Sciences Center (OUHSC)

Oklahoma City, Oklahoma, 73104, United States

Location

Cancer Care Associates

Tulsa, Oklahoma, 74104, United States

Location

Penn State Hershey Cancer Institute-Clinical Trials Office

Hershey, Pennsylvania, 17033, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Tennessee Cancer Center

Knoxville, Tennessee, 37920, United States

Location

Tennessee Oncology Sarah Cannon

Nashville, Tennessee, 37203, United States

Location

Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Durán i Reynals, Servicio de Oncología

Barcelona, 08908, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, 28220, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

MeSH Terms

Interventions

CUDC-907

Limitations and Caveats

Due to inconclusive efficacy at the interim analysis, enrollment was permanently stopped in August 2017.

Results Point of Contact

• Title: Reinhard von Roemeling, M.D., Senior Vice President, Clinical Development
• Organization: Curis, Inc.

rvonroemeling@curis.com

617-503-6500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 4, 2016
• Study Start: July 1, 2016
• Primary Completion: May 28, 2019
• Study Completion: May 28, 2019
• Last Updated: April 27, 2022
• Results First Posted: April 27, 2022

Record last verified: 2022-04

Locations

ES (5); US (20)