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NCT Number: NCT01283048

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

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.

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BKM-120 Bevacizumab

Drug

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

Other names: Avastin

Primary outcomes

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

    Time frame: 2 year

Secondary outcomes

  1. 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 frame: 2 year

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

    Time frame: 2 years

  3. 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 frame: 2 years

Sponsors and collaborators

Lead sponsor

Toni Choueiri, MD

Other

Collaborators

  • Beth Israel Deaconess Medical Center

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jan 25, 2011
Registry last updated
Sep 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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