A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma
This study is currently recruiting participants.
Verified February 2013 by Genentech
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01547546
First received: March 5, 2012
Last updated: February 6, 2013
Last verified: February 2013
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Purpose
This open-label, multicenter, Phase I, dose-escalating study will evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and efficacy of GDC-0084 in patients with progressive or recurrent high-grade glioma. Stage 1 is the dose escalation part of the study. Stage 2, patients will receive GDC-0084 at a recommended dose for future studies.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma, Glioma |
Drug: GDC-0084 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Phase I, Dose-escalation Study Evaluating the Safety and Tolerability of GDC-0084 Administered to Patients With Progressive or Recurrent High-grade Glioma |
Further study details as provided by Genentech:
Primary Outcome Measures:
- Safety: Incidence of adverse events [ Time Frame: approximately 2 years ] [ Designated as safety issue: Yes ]
- Maximum tolerated dose (MTD) [ Time Frame: approximately 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics: Area under the concentration-time curve [ Time Frame: Pre- and post-dose Days 1, 8, 15, 22 and 29 Cycle 1, Day 1 every following Cycle until 30 days after the last dose of study drug ] [ Designated as safety issue: No ]
- Best overall response rate, tumor assessments according to Response Assessment in Neuro-Oncology (RANO) [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 68 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single Arm |
Drug: GDC-0084
Multiple doses
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Interval of at least 12 weeks from completion of adjuvant radiotherapy for gliomas to study entry
- Karnofsky Performance Status of >/= 70 at screening
- Confirmed measurable disease per RANO
- Adequate hematologic and organ function
Patients enrolled in Stage 1:
- Histologically documented recurrent or progressive high-grade gliomas (WHO Grade III-IV)
- Prior treatment with at least one regimen for gliomas (radiotherapy with or without chemotherapy for Grade III gliomas and radiotherapy with chemotherapy for Grade IV gliomas) and/or not considered to be a candidate for regimens known to provide clinical benefit
Patients enrolled in Stage 2:
- Histologically documented recurrent or progressive glioblastoma (WHO Grade IV gliomas)
- Prior treatment with one or two regimens for glioblastoma (with the initial regimen consisting of radiotherapy with chemotherapy)
Exclusion Criteria:
- Treatment with anti-tumor therapy (approved or experimental) within 4 weeks prior to initiation of study drug
- Requirement for anticoagulants such as warfarin or any other warfarin-derivative anticoagulants; low-molecular-weight heparin is permitted
- Any contraindication to MRI examination
- Evidence of Grade >/= 1 intracranial hemorrhage
- Active congestive heart failure or ventricular arrhythmia requiring medication
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse or cirrhosis
- Unresolved toxicity from prior therapy with the exception of lymphopenia (for patients with prior temozolomide) and alopecia
- Pregnant or lactating women
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547546
Contacts
| Contact: Please reference Study ID Number: GO28070 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| United States, California | |
| Recruiting | |
| Los Angeles, California, United States, 90095 | |
| United States, Massachusetts | |
| Recruiting | |
| Boston, Massachusetts, United States, 02115 | |
| Recruiting | |
| Boston, Massachusetts, United States, 02114 | |
| Spain | |
| Recruiting | |
| Barcelona, Spain, 08035 | |
Sponsors and Collaborators
Genentech
Investigators
| Study Director: | Clinical Trials | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01547546 History of Changes |
| Other Study ID Numbers: | GO28070, 2011-004479-35 |
| Study First Received: | March 5, 2012 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Glioblastoma Glioma Astrocytoma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 21, 2013