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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01283048

Enrollment

Registered

2011-01-25

Start date

2011-09-30

Completion date

2016-09-30

Last updated

2016-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Carcinoma

Keywords

Kidney Cancer, Avastin

Brief summary

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.

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.

Interventions

DRUGBKM-120 Bevacizumab

BKM-120 60, 80, 100 mg PO QD Bevacizumab 10 mg/Kg every 2 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To determine the maximum tolerated dose and dose limiting toxicities of the combination of BKM-120 and bevacizumab in metastatic renal cell carcinoma	2 year

Secondary

Measure	Time frame
To determine additional toxicity and safety information from the combination of BKM-120 and bevacizumab in an expanded cohort of patients at the MTD	2 year
To determine the objective response proportion, progression-free survival, overall survival of the combination of BKM-120 and bevacizumab	2 years
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	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026