NCT01283048

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

5 years

First QC Date

January 24, 2011

Last Update Submit

September 19, 2016

Conditions

Renal Cell Carcinoma

Keywords

Kidney CancerAvastin

Outcome Measures

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

    2 year

Secondary Outcomes (3)

  • 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

Study Arms (1)

BKM-120 Bevacizumab

EXPERIMENTAL

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

Drug: BKM-120 Bevacizumab

Interventions

BKM-120 BevacizumabDRUG

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

Also known as: Avastin
BKM-120 Bevacizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal CellKidney Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Toni K Choueiri, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

January 24, 2011

First Posted

January 25, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 21, 2016

Record last verified: 2016-09

Locations

US(3)