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Report for Clinical Trial NCT01283048

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase I Study of Bevacizumab and Escalation Doses of BKM-120 in Patients With Metastatic Renal Cell Carcinoma Who Failed Prior Systemic Therapies

BKM-120 is a drug that may slow the growth of cancer cells. This drug has been used in laboratory experiments and information from those research studies suggests that this drug may help to slow the growth of renal cancer cells. In this research study, the investigators are testing the safety to BKM-120 at different dose levels. The investigators will also be studying how well tolerated BKM-120 is, and how effective BKM-120 can be in the treatment of kidney cancer.

NCT01283048 Renal Cell Carcinoma
MeSH:Carcinoma Carcinoma, Renal Cell
HPO:Carcinoma Clear cell renal cell carcinoma Papillary renal cell carcinoma Renal cell carcinoma

1 Interventions

Name: BKM-120 Bevacizumab

Description: BKM-120 60, 80, 100 mg PO QD Bevacizumab 10 mg/Kg every 2 weeks
Type: Drug
Group Labels: 1

BKM-120 Bevacizumab


Primary Outcomes

Measure: To determine the maximum tolerated dose and dose limiting toxicities of the combination of BKM-120 and bevacizumab in metastatic renal cell carcinoma

Time: 2 year

Secondary Outcomes

Measure: To determine additional toxicity and safety information from the combination of BKM-120 and bevacizumab in an expanded cohort of patients at the MTD

Time: 2 year

Measure: To determine the objective response proportion, progression-free survival, overall survival of the combination of BKM-120 and bevacizumab

Time: 2 years

Measure: To determine whether the BKM-120 and bevacizumab combination at the MTD is associated with concomitant changes in angiokines and PI3K pathway members in plasma and tumor samples

Time: 2 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 P13K

Inclusion Criteria: - Metastatic RCC with clear cell component or papillary RCC - Life expectancy > 12 weeks - Must have failed at least 1 prior anti-VEGF systemic therapy for metastatic RCC Exclusion Criteria: - Prior treatment with a P13K inhibitor or bevacizumab - Untreated brain metastases - Acute or chronic liver or pancreatic disease - Major mood disorder - Concurrent severe and/or uncontrolled medical condition - Diabetes mellitus - GI disease - Currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant - Pregnant or breastfeeding - HIV positive - History of another malignancy within 3 years except cured basal cell carcinoma of the skin or excised in situ carcinoma of the cervix - Uncontrolled hypertension Inclusion Criteria: - Metastatic RCC with clear cell component or papillary RCC - Life expectancy > 12 weeks - Must have failed at least 1 prior anti-VEGF systemic therapy for metastatic RCC Exclusion Criteria: - Prior treatment with a P13K inhibitor or bevacizumab - Untreated brain metastases - Acute or chronic liver or pancreatic disease - Major mood disorder - Concurrent severe and/or uncontrolled medical condition - Diabetes mellitus - GI disease - Currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant - Pregnant or breastfeeding - HIV positive - History of another malignancy within 3 years except cured basal cell carcinoma of the skin or excised in situ carcinoma of the cervix - Uncontrolled hypertension Renal Cell Carcinoma Carcinoma Carcinoma, Renal Cell Subjects will receive an intravenous infusion of Avastin on Day 1 and Day 15 of each month (cycle). --- P13K ---

Inclusion Criteria: - Metastatic RCC with clear cell component or papillary RCC - Life expectancy > 12 weeks - Must have failed at least 1 prior anti-VEGF systemic therapy for metastatic RCC Exclusion Criteria: - Prior treatment with a P13K inhibitor or bevacizumab - Untreated brain metastases - Acute or chronic liver or pancreatic disease - Major mood disorder - Concurrent severe and/or uncontrolled medical condition - Diabetes mellitus - GI disease - Currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant - Pregnant or breastfeeding - HIV positive - History of another malignancy within 3 years except cured basal cell carcinoma of the skin or excised in situ carcinoma of the cervix - Uncontrolled hypertension Inclusion Criteria: - Metastatic RCC with clear cell component or papillary RCC - Life expectancy > 12 weeks - Must have failed at least 1 prior anti-VEGF systemic therapy for metastatic RCC Exclusion Criteria: - Prior treatment with a P13K inhibitor or bevacizumab - Untreated brain metastases - Acute or chronic liver or pancreatic disease - Major mood disorder - Concurrent severe and/or uncontrolled medical condition - Diabetes mellitus - GI disease - Currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant - Pregnant or breastfeeding - HIV positive - History of another malignancy within 3 years except cured basal cell carcinoma of the skin or excised in situ carcinoma of the cervix - Uncontrolled hypertension Renal Cell Carcinoma Carcinoma Carcinoma, Renal Cell Subjects will receive an intravenous infusion of Avastin on Day 1 and Day 15 of each month (cycle). --- P13K --- --- P13K ---



HPO Nodes


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