Bevacizumab and BKM-120 in Patients With Metastatic Renal Cell Carcinoma

Condition(s) targeted: Renal Cell Carcinoma

Intervention: BKM-120 Bevacizumab (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Toni Choueiri, MD

Official(s) and/or principal investigator(s):
Toni K Choueiri, MD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute

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.

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

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

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

Secondary outcome:

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

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

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

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02215, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201, United States

Starting date: September 2011
Last updated: June 3, 2015