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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05673876
Other study ID # GA43861
Secondary ID ISRCTN27200385
Status Terminated
Phase Phase 1
First received
Last updated
Start date April 6, 2023
Est. completion date January 15, 2024

Study information

Verified date January 2024
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of the study is to assess the safety and pharmacokinetics (PK) of GDC-8264 in participants with acute graft-versus-host disease (aGVHD).


Recruitment information / eligibility

Status Terminated
Enrollment 7
Est. completion date January 15, 2024
Est. primary completion date January 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of post-allogeneic hematopoietic stem cell transplantation (HSCT) aGVHD at screening - Evidence of engraftment post-transplant - Diagnosis of high-risk aGVHD, per refined Minnesota high-risk aGVHD criteria during screening - Initiation of treatment with systemic corticosteroids for aGVHD at a dose of prednisone =2 milligrams per kilograms per day (mg/kg/day) by orally (PO) or methylprednisolone =2 mg/kg/day intravenously (or equivalent) in divided doses at diagnosis and up to 3 days prior to or on the same day as initiation of GDC-8264 (Day 1), with no taper planned prior to Day 3 Exclusion Criteria: - Evidence of relapsed, progressing, or persistent malignancy, or treatment for relapse after transplant, or requirement for rapid immune suppression withdrawal as pre-emergent treatment of early malignancy relapse - Prior receipt of more than one allogeneic HSCT - Prior receipt of solid organ transplantation that are target organs for aGVHD (e.g., liver transplant) - Prior systemic treatment for aGVHD, except for the standard of care corticosteroid treatment initiated as part of this trial - Diagnosis of chronic GVHD or overlap syndrome - Uncontrolled active infection (i.e., progressive symptoms related to infection despite treatment, or persistently positive blood cultures despite treatment, or any other evidence of severe sepsis) - Severe organ dysfunction (e.g., acute liver failure, renal failure requiring dialysis, ventilator support, or vasopressor therapy) - Initiation or planned use of a marketed small molecule (excluding corticosteroids) or biologic therapy as treatment for aGVHD from the start of screening through the treatment period

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GDC-8264
GDC-8264 tablets will be administered as per the schedule specified in the respective arms.

Locations

Country Name City State
Canada McMaster University Medical Centre Hamilton Ontario
Canada Princess Margaret Cancer Centre Toronto Ontario
United States Massachusetts General Hospital; Harvard Medical School - Gi Unit Grj724 Boston Massachusetts
United States City of Hope National Medical Center Duarte California
United States Columbia University Irving Medical Center New York New York
United States Icahn School of Medicine at Mount Sinai New York New York
United States Abramson Cancer Center; Univ of Pennsylvania; PERELMAN CENTER FOR ADVANCED MEDICINE Philadelphia Pennsylvania
United States Mayo Clinic - PPDS Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants with At Least One Adverse Events (AEs) and As per Severity of AEs Screening up to end of study (up to approximately 3 years)
Primary Plasma Concentration of GDC-8264 From Day 1 up to Day 57
Secondary Overall Response Rate (ORR) Up to Day 29
Secondary Duration of Response (DOR) From Day 29 up to end of study (up to approximately 3 years)
Secondary Percentage of Participants with aGVHD Flares Baseline up to Day 56
Secondary Percentage of Participants with Non-relapse Mortality (NRM) Baseline up to Day 180
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