A Multicenter, Single-Arm, Open-Label, Phase II Study of GDC-0980 for The Treatment of Recurrent or Persistent Endometrial Carcinoma
| City: |
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Durham |
| State: |
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North Carolina |
| Zip Code: |
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27710 |
| Conditions: |
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Endometrial Carcinoma |
| Purpose: |
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This is a multicenter, single-arm, open-label Phase II study to evaluate the activity of
GDC-0980 in patients with recurrent or persistent endometrial cancer. The safety,
tolerability, and pharmacokinetics of GDC-0980 will also be evaluated.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Patients must have recurrent or persistent endometrial carcinoma that is refractory
to curative therapy or established treatments
- Histologic confirmation of the original primary tumor is required
- Histologic or cytologic confirmation of the recurrent/progressive disease is desired
- Patients must have had at least one but no more than two prior chemotherapeutic
regimens for management of endometrial carcinoma
- Disease that is measurable per RECIST v1.1
- No active infection requiring antibiotics
- Any hormonal therapy directed at the malignant tumor must be discontinued at least 2
weeks prior to first study treatment
- Any other prior therapy directed at the malignant tumor, including immunologic agents
and radiotherapy, must be discontinued at least 2 weeks prior to first study
treatment
- Adequate hematologic and end organ function
Exclusion Criteria:
- Type I diabetes or Type II diabetes requiring insulin
- Prior use of mTOR/PI3K inhibitor
- Current dyspnea at rest or any requirement for supplemental oxygen therapy to perform
activities of daily living
- Previous diagnosis of pulmonary fibrosis of any cause
- History of myocardial infarction or unstable angina within 6 months prior to first
study treatment
- Congestive heart failure
- History of malabsorption syndrome or other condition that would interfere with
enteral absorption
- Clinically significant history of liver disease, including cirrhosis and current
alcohol abuse
- Presence of positive test results for hepatitis B or hepatitis C
- Known HIV infection
- Active autoimmune disease that is not controlled by nonsteroidal anti inflammatory
drugs
- Need for current chronic corticosteroid therapy
- Pregnancy, lactation, or breastfeeding
- Current severe, uncontrolled systemic disease
- Major surgical procedure or significant traumatic injury within 28 days prior to Day
1 or anticipation of the need for major surgery during the course of study treatment
- Uncontrolled hypercalcemia
- Leptomeningeal disease as a manifestation of cancer
- Known untreated or active brain metastases
- Grade >=2 hypercholesterolemia or hypertriglyceridemia
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| NCT ID: |
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NCT01455493 |
| Primary Contact: |
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Study Director
Clinical Trials
Genentech
Please reference Study ID Number: PIM4972g www.roche.com/about_roche/roche_worldwide.htm
Phone: 888-662-6728 (U.S. Only)
Email: genentechclinicaltrials@druginfo.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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Durham, North Carolina 27710
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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