Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)

Stopped early · Phase 3

Conditions studied: Follicular Lymphoma (FL), Non Hodgkin Lymphoma, Marginal Zone Lymphoma

In brief

This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.

Key facts

Study ID

NCT04745832

Run by

MEI Pharma, Inc.

People needed

82

Starts

2021-08-13

Expected to finish

2023-03-20

Last updated by the study team

2024-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects ≥18 years of age, ≥19 years in Korea, or ≥20 years for subjects in Japan and Taiwan
• Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype limited to:
• FL Gr 1, Gr 2, or Gr 3a
• MZL (splenic, nodal, or extra-nodal)
• Subjects with relapsed or refractory disease who received ≥1 prior lines of therapy
• Subjects must have at least one bi-dimensionally measurable lesion >1.5 cm
• Adequate hematologic parameters at screening unless abnormal values are due to disease
• Adequate renal and hepatic function
• Adequate cardiac function based on ECG and LVEF assessments

You may not qualify if…

• Histologically confirmed diagnosis of FL Gr 3b or transformed disease
• Prior therapy with PI3K inhibitors
• Ongoing or history of drug-induced pneumonitis
• Known lymphomatous involvement of the central nervous system
• Tested positive for or active viral infection with hepatitis B or C virus
• Tested positive or active infection with human immunodeficiency virus
• Tested positive, or active infection with human T-cell leukemia virus type 1
• Any uncontrolled clinically significant illness
• History of clinically significant cardiovascular abnormalities such as congestive heart failure
• History of clinically significant gastrointestinal (GI) conditions
• Females who are pregnant

Where it is running

• Orange Coast Memorial Medical Center — Fountain Valley, California, United States
• Long Beach Memorial Medical Center — Long Beach, California, United States
• The Oncology Institute of Hope and Innovation — Riverside, California, United States
• BRCR Medical Center Inc — Hollywood, Florida, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Revive Research Institute — Farmington Hills, Michigan, United States
• Revive Research Institute — Sterling Heights, Michigan, United States
• Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center — Springfield, Missouri, United States
• Inspira Medical Center Mullica Hill — Mullica Hill, New Jersey, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Alpha Research Institute, LLC — Baytown, Texas, United States
• Valley Cancer Associates — Harlingen, Texas, United States
• Community Cancer Trials of Utah — Ogden, Utah, United States
• Canberra Hospital — Garran, Australia
• The Perth Blood Institute (PBI) — West Perth, Australia
• Westmead Hospital — Westmead, Australia
• AZ Sint-Jan Burgge-Oostende AV — Bruges, Belgium
• UZ Brussel — Brussels, Belgium
• Universitair Ziekenhuis Antwerpen — Edegem, Belgium
• Center Hospitalier de Jolimont — Haine-Saint-Paul, Belgium
• UZ Leuven Campus Gasthuisberg — Leuven, Belgium
• Eastern Regional Health Authority — St. John's, Newfoundland and Labrador, Canada
• Centre intégré universitaire de santé et de services sociaux de l'Estrie — Sherbrooke, Quebec, Canada
• McGill University Health Centre — Québec, Canada
• The Oncology Institute of Hope and Innovation — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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