Trial record 1 of 1 for:
NCT00876109
A Study of GDC-0941 in Patients With Locally Advanced or Metastatic Solid Tumors for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or Intolerable
This study is ongoing, but not recruiting participants.
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00876109
First received: March 13, 2009
Last updated: February 6, 2013
Last verified: February 2013
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Purpose
This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of orally administered GDC-0941 administered QD and BID.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Cancers |
Drug: GDC-0941 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Phase I, Dose-Escalation Study Evaluating Two Dosing Schedules of PI3-Kinase Inhibitor (GDC-0941) in Patients With Locally Advanced or Metastatic Solid Tumors for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or Intolerable |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Occurrence of adverse events by NCI CTCAE grade and associated dose of GDC-0941 [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
- Occurrence of dose-limiting toxicities (DLTs) by NCI CTCAE grade and associated dose of GDC-0941 [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
- Occurrence of Grade 3 or 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0941 [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
- PK parameters after single and multiple doses of GDC-0941 [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Best overall response, duration of objective response, and progression-free survival (PFS) for patients with measurable disease according to RECIST [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
| Enrollment: | 108 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | April 2014 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: GDC-0941
Escalating oral dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically documented, incurable, locally advanced, or metastatic solid malignancy that has progressed or failed to respond to at least one prior regimen. Patients must not be candidates for regimens known to provide clinical benefit.
- Evaluable or measurable disease per RECIST
- Life expectancy of >= 12 weeks
- Documented willingness to use an effective means of contraception for both men and women while participating in the study
Exclusion Criteria:
- Leptomeningeal disease as the only manifestation of the current malignancy
- History of Type 1 or 2 diabetes mellitus requiring regular medication
- Any condition requiring anti-coagulants, such as warfarin, heparin, or thrombolytics
- Malabsorption syndrome or other condition that would interfere with enteral absorption
- Known untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for >= 3 months
- Active congestive heart failure or ventricular arrhythmia requiring medication
- Uncontrolled ascites requiring weekly large-volume paracentesis for 3 consecutive weeks prior to enrollment
- Active infection requiring intravenous (IV) antibiotics
- Patients requiring any daily supplemental oxygen
- Uncontrolled hypomagnesemia or hypokalemia, defined as values below the lower limit of normal (LLN) or hypercalcemia above the ULN for the institution despite adequate electrolyte supplementation or management
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- Known human immunodeficiency virus (HIV) infection
- Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patients at high risk from treatment complications
- Significant traumatic injury within 3 weeks before Day 1
- Major surgical procedure within 4 weeks prior to initiation of study treatment
- Treatment with chemotherapy, hormonal therapy (except GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, or radiation therapy (except palliative radiation to bony metastases) as cancer therapy within 4 weeks prior to initiation of study treatment
- Palliative radiation to bony metastases within 2 weeks prior to initiation of study treatment
- Need for chronic corticosteroid therapy for > 7 days
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876109
Locations
| United States, Arizona | |
| Scottsdale, Arizona, United States, 85258 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Detroit, Michigan, United States, 48201 | |
Sponsors and Collaborators
Genentech
Investigators
| Study Director: | Gallia Levy, M.D. | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00876109 History of Changes |
| Other Study ID Numbers: | GDC4255g, GO01300 |
| Study First Received: | March 13, 2009 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Genentech:
|
Metastatic Solid Tumors PI3K PI3K Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013