A Phase 1b, Open-Label, Dose-Finding Study to Evaluate the Safety of Tivozanib (AV-951) in Combination With Temsirolimus in Subjects With Metastatic Renal Cell Carcinoma
NCT ID: NCT00563147
Last Updated: 2011-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2007-11-30
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
tivozanib (AV-951) plus temsirolimus
tivozanib (AV-951) plus temsirolimus
ascending doses of tivozanib (AV-951) capsules administered orally for 21 days with discontinuation for 7 days; ascending doses of temsirolimus administered intravenously every 7 days
Interventions
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tivozanib (AV-951) plus temsirolimus
ascending doses of tivozanib (AV-951) capsules administered orally for 21 days with discontinuation for 7 days; ascending doses of temsirolimus administered intravenously every 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed renal cell carcinoma with a clear cell component
* Documented progressive disease
* Measurable disease by RECIST criteria
* No more than 1 prior VEGF receptor targeted therapy; no prior treatment with temsirolimus or other drugs targeting the mTOR pathway
* Karnofsky performance status \> 70%; life expectancy ≥ 3 months
* Ability to give written informed consent
Exclusion Criteria
* Primary CNS malignancies; active CNS metastases
* Hematologic malignancies (including leukemia in any form, lymphoma, and multiple myeloma)
* Any of the following hematologic abnormalities:
* Hemoglobin \< 9.0 g/dL
* ANC \< 1500 per mm3
* Platelet count \< 100,000 per mm3
* Any of the following serum chemistry abnormalities:
* Fasting serum cholesterol \> 350 mg/dL
* Fasting triglycerides \> 400 mg/dL
* Total bilirubin \> 1.5 × ULN
* AST or ALT \> 2.5 × ULN (or \> 5 x ULN in subjects with liver metastasis)
* Serum albumin \< 3.0 g/dL
* Creatine \> 1.5 × ULN (or calculated CLCR \<50 mL/min/1.73 m2)
* Proteinuria \> 2.5 g/24 hours or 3+ with urine dipstick
* Significant cardiovascular disease, including:
* Active clinically symptomatic left ventricular failure
* Active hypertension (diastolic blood pressure \> 100 mmHg). Subjects with a history of hypertension must have been on stable doses of anti-hypertensive drugs for ≥ 4 weeks
* Uncontrolled hypertension: Blood pressure \>140/90 mmHg on 2 or more antihypertensive medications
* Myocardial infarction within 3 months prior to administration of first dose of study drug
* Subjects with delayed healing of wounds, ulcers, and/or bone fractures
* Pulmonary hypertension or pneumonitis
* Serious/active infection; infection requiring parenteral antibiotics
* Inadequate recovery from any prior surgical procedure; major surgical procedure within 6 weeks prior to study entry
* Uncontrolled psychiatric disorder, altered mental status precluding informed consent or necessary testing
* Inability to comply with protocol requirements
* Ongoing hemoptysis or history of clinically significant bleeding
* Cerebrovascular accident within 12 months of study entry, or peripheral vascular disease with claudication on walking less than 1 block
* Deep venous thrombosis or pulmonary embolus within 6 months of study entry and/or ongoing need for full-dose oral or parenteral anticoagulation
* Subjects with a "currently active" second primary malignancy other than non-melanoma skin cancers. Subjects are not considered to have a "currently active" malignancy if they have completed anti-cancer therapy and are considered by their physician to be \< 30% risk of relapse.
* Pregnant or lactating women
* Known concomitant genetic or acquired immune suppression disease such as HIV
Prohibited medications:
* VEGF receptor (VEGFR) targeted therapy within 4 weeks prior to and during study
* Other signal transduction inhibitors, monoclonal antibodies, etc., within 4 weeks prior to and during study
* Immunotherapy or biological response modifiers within 4 weeks prior to and during study
* Systemic hormonal therapy within 4 weeks prior to and during study, with the exception of:
* Hormonal therapy for appetite stimulation or contraception
* Nasal, ophthalmic, and topical glucocorticoid preparations
* Oral replacement therapy for adrenal insufficiency
* Low-dose maintenance steroid therapy for other conditions
* Herbal preparations/supplements (except for a daily multivitamin/mineral supplement not containing herbal components) within 2 weeks prior to or during study
* Any experimental therapy 4 weeks prior to and during study
* Radiotherapy:
* At least 2 weeks since prior local radiation therapy (ie, involving \<25% of bone marrow) at the time of study entry
* At least 4 weeks since prior radiation therapy involving ≥ 25% of bone marrow
* Treatment with CYP3A4 inducers or inhibitors during the study
18 Years
ALL
No
Sponsors
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AVEO Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joshua Zhang, M.D.
Role: STUDY_DIRECTOR
AVEO Pharmaceuticals
Locations
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UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Stanford University
Stanford, California, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
The Methodist Hospital Research Institute
Houston, Texas, United States
Countries
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References
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Fishman MN, Srinivas S, Hauke RJ, Amato RJ, Esteves B, Cotreau MM, Strahs AL, Slichenmyer WJ, Bhargava P, Kabbinavar FF. Phase Ib study of tivozanib (AV-951) in combination with temsirolimus in patients with renal cell carcinoma. Eur J Cancer. 2013 Sep;49(13):2841-50. doi: 10.1016/j.ejca.2013.04.019. Epub 2013 May 28.
Other Identifiers
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AV-951-07-102
Identifier Type: -
Identifier Source: org_study_id