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

Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283048
• Other study ID #: 10-405
• Status: Completed
• Phase: Phase 1
• First received: January 24, 2011
• Last updated: September 19, 2016
• Start date: September 2011
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Toni Choueiri, MD	Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	To determine the objective response proportion, progression-free survival, overall survival of the combination of BKM-120 and bevacizumab		2 years	No
Secondary	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	No