A Safety and Tolerability Study of INCB053914 in Combination With INCB050465 in Diffuse Large B-Cell Lymphoma

NCT03688152 | Completed Phase 1 FDA Drug

• 1 other identifier: INCB 53914-102
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of INCB053914 in combination with INCB050465 in relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Conditions

Relapsed Diffuse Large B-Cell Lymphoma; Refractory Diffuse Large B-Cell Lymphoma

Keywords

Diffuse large B-cell lymphoma; DLBCL; Non-Hodgkin lymphoma; phosphatidylinositol 3-kinase delta inhibitor; PI3Kδ; PIM kinases

Outcome Measures

Primary Outcomes (1)

• Number of treatment-emergent adverse events (TEAEs)

  TEAE is defined as an adverse event reported for the first time or worsening of a pre-existing event after the first dose of study treatment.

  Up to approximately 6 months

Secondary Outcomes (8)

• Cmax of INCB053914 in combination with INCB050465

  Day 15

• Tmax of INCB053914 in combination with INCB050465

  Day 15

• Cmin of INCB053914 in combination with INCB050465

  Day 15

• AUC0-t of INCB053914 in combination with INCB050465

  Day 15

• Cl/F of INCB053914 in combination with INCB050465

  Day 15

Study Arms (1)

INCB053914 + INCB050465

EXPERIMENTAL

INCB053914 in combination with INCB050465.

Drug: INCB053914; Drug: INCB050465

Interventions

INCB053914 DRUG

Dose Escalation: INCB053914 at the protocol-defined starting dose in combination with INCB050465, with dose modifications based on tolerability criteria. Dose Expansion: Recommended dose from the dose-escalation study.

INCB053914 + INCB050465

INCB050465 DRUG

Dose Escalation: INCB050465 at the protocol-defined starting dose in combination with INCB053914, with dose modifications based on tolerability criteria. Dose Expansion: Recommended dose from the dose-escalation study.

INCB053914 + INCB050465

Eligibility Criteria

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

You may qualify if:

• Relapsed or refractory DLBCL, which has been histologically documented, defined as having received at least 2 but no more than 5 prior systemic treatment regimens (eg, an anti-CD20 antibody, an anti-CD20 antibody with or without chemotherapy, or chemotherapy alone) and ineligible for further treatment with standard of care.
• Willing to undergo pretreatment and on-treatment incisional or excisional biopsy of nontarget adenopathy or extranodal lesions. Provision of the most recent, available archived tumor biopsy may satisfy the pretreatment biopsy.
• Measurable disease as defined by the Lugano classification criteria:
• ≥ 1 measurable nodal lesion (≥ 1.5 cm in longest dimension) or ≥ 1 measurable extranodal lesion (\> 1 cm in longest dimension) on CT scan or MRI
• ≥ 1 PET-avid lesion.
• Eastern Cooperative Oncology Group performance status 0 to 2.
• Willingness to avoid pregnancy or fathering children based on protocol-defined the criteria.

You may not qualify if:

• Laboratory values outside the protocol-defined range at screening unless approved by the medical monitor.
• Primary mediastinal (thymic) large B-cell lymphoma or Richter's Syndrome.
• Known brain or central nervous system metastases or history of uncontrolled seizures.
• Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment.
• Allogeneic stem cell transplant within the last 6 months, or active graft-versus-host disease following allogeneic transplant, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
• Use of immunosuppressive therapy following allogenic transplant within 28 days of the first dose of study treatment.
• Prior treatment with a PIM inhibitor, selective PI3Kδ inhibitor (eg, idelalisib), or a pan-PI3K inhibitor.
• Receipt of anticancer medications, therapies, or investigational drugs within protocol-defined intervals before the date of the first dose of study treatment.
• Current or previous other malignancy within 3 years of study entry, except cured (or treated with curative intent and no evidence of disease) basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without sponsor approval.
• History of liver function abnormality requiring investigation and/or treatment (eg, due to excessive alcohol or drug-induced liver injury).
• Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease.
• Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment, and exposure to a live vaccine within 30 days of study treatment administration.
• Known HIV infection.
• Evidence of HBV or HCV infection.
• History of stroke or intracranial hemorrhage within 6 months of the date of study treatment administration.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (3)

University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

Location

UCLA Healthcare Hematology-Oncology

Santa Monica, California, 90404, United States

Location

Clinical Research Alliance

Lake Success, New York, 11042, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin

Interventions

parsaclisib

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Fred Zheng, MD

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 28, 2018
• Study Start: December 3, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)