NCT01501604

Brief Summary

In people whos cancers have a PIK3CA mutation, this trial will be evaluating the drug BKM120 as a possible treatment. BKM120 works by blocking the phosphatidylinositol-3-kinase (PI3K)pathway, thereby inhibiting tumor growth and survival. The purpose of this study is to learn if the study drug BKM120 can shrink or slow the growth of your tumor. The safety of BKM120 will also be studied. Your physical state, symptoms, change in the size of your tumor, and laboratory findings obtained while you are on study will help the research team decide if BKM120 is safe and effective in patients with advanced cancers.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2 lung-cancer

Status
withdrawn

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

December 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

September 17, 2015

Status Verified

September 1, 2015

Enrollment Period

1.6 years

First QC Date

December 27, 2011

Last Update Submit

September 16, 2015

Conditions

Lung CancerBreast CancerColorectal CancerCholangiocarcinomaSolid Tumors

Keywords

PIK3CA mutationAdvanced solid tumors

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    Objective Response Rate (CR or PR) by RECIST 1.1 criteria

    2 years

Secondary Outcomes (3)

  • Clinical Benefit Rate

    2 years

  • Survival

    2 years

  • Clinical Benefit

    2 years

Interventions

BKM120DRUG

100 MG PO QD in cycles of 28 days

Eligibility Criteria

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

You may qualify if:

  • At least 1 site of measurable disease
  • Life expectancy \>/= 12 weeks
  • Adequate marrow and organ function
  • Diagnosis of lung cancer, breast cancer, colorectal cancer, cholangiocarcinoma, gastric cancer, pancreatic cancer, prostate cancer, uterine cancer, ovarian cancer, esophageal cancer, or head and neck cancer
  • Pathologically documented, definitively diagnosed, advanced solid tuor that is refractory to standard treatment, for which no standard therapy is available, or the subject refuses standard therapy
  • Cancer must have at least one of the following PIK3CA mutations: E542K, E545K, H1047R, H1047L. The PIK3CA mutation must be documented in a CLIA approved laboratory

You may not qualify if:

  • Prior treatment with a P13K inhibitor
  • Known hypersensitivity to BKM120 or its excipients
  • Untreated brain metastases
  • Acute or chronic liver, renal disease or pancreatitis
  • Currently treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A
  • Diarrhea \>/= CTCAE grade 2
  • Any concurrent severe and/or uncontrolled medical condition
  • Active cardiac disease
  • History of cardiac dysfunction
  • Poorly controlled diabetes mellitus or steroid-induced diabetes mellitus
  • Significant symptomatic deterioration of lung function
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKDM120 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  • Currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant
  • Pregnant or breast-feeding
  • Known diagnosis of HIV infection
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung NeoplasmsBreast NeoplasmsColorectal NeoplasmsCholangiocarcinoma

Interventions

NVP-BKM120

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Jeffrey A Engelman, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Thoracic Oncology

Study Record Dates

First Submitted

December 27, 2011

First Posted

December 29, 2011

Study Start

January 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

September 17, 2015

Record last verified: 2015-09