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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Renal Cell Carcinoma

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Trial Information

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


Subjects will receive an intravenous infusion of Avastin on Day 1 and Day 15 of each month
(cycle). Subjects will take a daily oral dose of BKM-120 at the dose level assigned.

Subjects will have a clinic visit weekly during Cycle 1 and then on Day 1 and Day 15 of each
cycle for blood tests and physical exam.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

2 year

Safety Issue:

Yes

Principal Investigator

Toni K Choueiri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

10-405

NCT ID:

NCT01283048

Start Date:

September 2011

Completion Date:

December 2013

Related Keywords:

  • Renal Cell Carcinoma
  • Kidney Cancer
  • Avastin
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115