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View Clinical Trial (Medical Research Study)
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A Study Evaluating GDC-0980 Administered Once Daily in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma - NCT00854152-02115 (Clinical Trial 317022)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy317022.aspx
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| City: |
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Boston |
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State:
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MA |
| Zip Code: |
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02115 |
| Conditions: |
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Non-Hodgkin's Lymphoma - Solid Cancers |
| Purpose: |
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This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and
pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with
incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or
failed to respond to at least one prior regimen or for which there is no standard therapy.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Histologically documented, incurable, locally advanced or metastatic solid
malignancies, or NHL without leukemic phase, that has progressed despite standard of
care therapy or for which there is no standard therapy of proven clinical benefit
- Evaluable or measurable disease per RECIST and/or the following: prostate cancer
patients with non-measurable disease are eligible if they have two rising
prostate-specific antigen (PSA) levels that meet the PSA Working Group criteria for
progression prior to initiation of study treatment; ovarian cancer patients with
non-measurable disease are eligible if they have two rising CA-125 levels greater
than the ULN ≥ 2 weeks apart prior to initiation of study treatment.
- Life expectancy ≥ 12 weeks
- Adequate hematologic and organ function within 14 days before initiation of GDC-0980
- 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
- Grade ≥ 2 hypercholesterolemia or hypertriglyceridemia
- Any condition requiring anti-coagulants such as warfarin, heparin, or
anti-thrombotics
- Malabsorption syndrome or other condition that would interfere with enteral
absorption
- Known untreated malignancies of the brain or spinal cord, or treated brain metastases
that are not radiographically stable for ≥ 3 months
- Active congestive heart failure or ventricular arrhythmia requiring medication
- Active infection requiring IV antibiotics
- Requirement for any daily supplemental oxygen
- Uncontrolled hypomagnesemia
- Hypercalcemia requiring continued use of bisphosphonate therapy
- Clinically significant history of liver disease, including viral or other hepatitis,
current alcohol abuse, or cirrhosis
- Known HIV infection
- Significant traumatic injury within 4 weeks of Day 1
- Major surgical procedure within 4 weeks prior to initiation of GDC-0980
- Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy,
oral contraceptives, or GnRH agonists or antagonists for prostate cancer),
immunotherapy, biologic therapy, radiation therapy (except palliative radiation to
bony metastases), or herbal therapy as cancer therapy within 3 weeks prior to
initiation of GDC-0980
- Palliative radiation to bony metastases within 2 weeks prior to initiation of
GDC-0980
- Need for chronic corticosteroid therapy of ≥ 10 mg of prednisone per day or an
equivalent dose of other anti-inflammatory corticosteroids or immunosuppressant
- Treatment with an investigational agent within 4 weeks prior to initiation of
GDC-0980
- Unresolved toxicity from prior therapy except for alopecia and Grade 1 peripheral
neuropathy
- Pregnancy or lactation |
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| Study is available at: |
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Investigational Site
Boston, MA 02115
United States
Primary Contact:
Mick O'Quigley
Email: oquigley.michael@gene.com |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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