A Study of GDC-0853 in Patients With Resistant B-Cell Lymphoma or Chronic Lymphocytic Leukemia.
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| ClinicalTrials.gov Identifier: NCT01991184 |
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Recruitment Status :
Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : October 19, 2018
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Sponsor:
Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
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Brief Summary:
This open-label, Phase I study will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0853 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia. In a dose-expansion part, GDC-0853 will be assessed in subsets of patients.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma | Drug: GDC-0853 | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 24 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | AN OPEN-LABEL, PHASE I, DOSE-ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF GDC-0853 IN PATIENTS WITH RELAPSED OR REFRACTORY B-CELL NON-HODGKIN'S LYMPHOMA AND CHRONIC LYMPHOCYTIC LEUKEMIA |
| Actual Study Start Date : | December 16, 2013 |
| Estimated Primary Completion Date : | March 1, 2019 |
| Estimated Study Completion Date : | March 1, 2019 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Dose-escalation |
Drug: GDC-0853
Multiple escalating doses |
Primary Outcome Measures :
- Safety: Incidence of dose-limiting toxicities (DLTs) of GDC-0853 [ Time Frame: Approximately 1 year ]
- Safety: Maximum tolerated dose (MTD) of GDC-0853 [ Time Frame: Approximately 1 year ]
Secondary Outcome Measures :
- Safety: Incidence of adverse events [ Time Frame: Approximately 2 years ]
- Pharmacokinetics: Area under the concentration-time curve (AUC) of GDC-0853 [ Time Frame: 35 days ]
- Pharmacokinetics: Maximum concentration (Cmax) of GDC-0853 [ Time Frame: 35 days ]
- Objective response to GDC-0853 [ Time Frame: Approximately 2 years ]
- Progression-free survival [ Time Frame: Approximately 2 years ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age >/= 18 years
- ECOG score of 0-1
- One of the following histologically-documented hematologic malignancies for which no effective standard therapy exists: indolent non Hodgkin's lymphoma (NHL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL)
- At least one site of disease that, as seen on CT scan, is > 1.5 cm in the greatest transverse diameter or > 1.0 cm in short axis diameter (except for patients with CLL)
- An available tumor specimen
- Adequate hematologic and organ function
- For female patients of childbearing potential and male patients with partners of childbearing potential, use of effective contraceptive(s) as defined by protocol for the duration of the study
Exclusion Criteria:
- Life expectancy < 12 weeks
- < 3 weeks since the last anti-tumor therapy, including chemotherapy, biologic, experimental, hormonal or radiotherapy (with the exception of leuprolide or similar medications for prostate cancer)
- Recent major surgical procedure or traumatic injury, or unhealed incisions or wounds
- Active infection requiring IV antibiotics
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.
- Primary CNS malignancy or untreated/active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
- History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin cancer, Stage I uterine cancer, or other cancers with a similar outcome
- Cardiovascular dysfunction, including ventricular dysrhythmias or risk factors for ventricular dysrhythmias
- Pregnancy, or lactation
- Any other diseases that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991184
Locations
| United States, California | |
| Stanford Cancer Center | |
| Stanford, California, United States, 94305-5820 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Ohio | |
| The Ohio State University Wexner Medical Center | |
| Columbus, Ohio, United States, 43212 | |
| United States, Oregon | |
| Willamette Valley Cancer Ctr - 520 Country Club | |
| Eugene, Oregon, United States, 97401-8122 | |
| Oregon Health Sciences Uni | |
| Portland, Oregon, United States, 97239 | |
| United States, Tennessee | |
| Sarah Cannon Cancer Center - Tennessee Oncology, Pllc | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Washington | |
| Seattle Cancer Care Alliance | |
| Seattle, Washington, United States, 98109 | |
| Australia, Queensland | |
| Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology | |
| Woolloongabba, Queensland, Australia, 4102 | |
| Australia, Victoria | |
| Peter MacCallum Cancer Centre; Department of Haematology | |
| Melbourne, Victoria, Australia, 3002 | |
| Australia, Western Australia | |
| Linear Clinical Research Limited | |
| Nedlands, Western Australia, Australia, 6009 | |
Sponsors and Collaborators
Genentech, Inc.
Investigators
| Study Director: | Clinical Trials | Genentech, Inc. |
| Responsible Party: | Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT01991184 History of Changes |
| Other Study ID Numbers: |
GO29089 |
| First Posted: | November 25, 2013 Key Record Dates |
| Last Update Posted: | October 19, 2018 |
| Last Verified: | October 2018 |
Additional relevant MeSH terms:
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Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Lymphoma, Non-Hodgkin |