Lung CancerPhase 2NCT01501604
BKM120 in Cancers With PIK3CA Activating Mutations
A Phase 2 study testing BKM120 in people with Lung Cancer and Breast Cancer, run by Massachusetts General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Breast Cancer, Colorectal Cancer
- What is being tested?
- BKM120
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- History of another malignancy within 3 years, except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervix
- Unable to swallow the medication in its prescribed form
About this study
Official title: An Open Label, Phase II Trial of BKM120 in Cancers With PIK3CA Activating Mutations
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.
Read the detailed description
Subjects enrolled in this study will receive BKM120 once daily, orally, in cycles of 28 days.
During Cycles 1 and 2, the following tests and procedures will be done on days 1 and 15:
- physical exam
- performance status
- blood tests
- pregnancy test (if applicable)
- neuropsychiatric assessments
Starting at Cycle 2 and then every other cycle thereafter (approximately every 8 weeks) tumor assessment will be performed by CT/MRI or PET scan. A chest x-ray will also be performed every 8 weeks.
Beginning with Cycle 3, the following tests/procedures will be performed on Day 1 of each cycle:
- physical exam
- performance status
- blood tests
- neuropsychiatric assessments
- Conditions
- Lung Cancer, Breast Cancer, Colorectal Cancer, Cholangiocarcinoma, Solid Tumors
- Being tested
- BKM120
- Keywords
- PIK3CA mutation, Advanced solid tumors
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BKM120Drug
100 MG PO QD in cycles of 28 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Objective Response Rate (CR or PR) by RECIST 1.1 criteria
Measured: 2 years
Secondary outcomes (3)
Clinical Benefit Rate
Clinical Benefit Rate (CR, PR, or SD) by RECIST 1.1 criteria
Measured: 2 years
Survival
Progression Free Survival (PFS)
Measured: 2 years
Clinical Benefit
Determine if the presence of specific co-existing mutations may influence clinical benefit from BKM120
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: The study has been closed due to lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Jeffrey Engelman, Massachusetts General Hospital
- Investigators
- Jeffrey A Engelman, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501604
- Sponsor's protocol ID
- 11-211
- Status last verified
- Sep 2015
- First submitted
- 27 Dec 2011
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase II Trial of BKM120 in Cancers With PIK3CA Activating Mutations
- ClinicalTrials.gov ID
- NCT01501604
- Acronym / sponsor ID
- 11-211
- Conditions
- Lung Cancer, Breast Cancer, Colorectal Cancer, Cholangiocarcinoma, Solid Tumors
- Keywords
- PIK3CA mutation, Advanced solid tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study has been closed due to lack of accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 29 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects enrolled in this study will receive BKM120 once daily, orally, in cycles of 28 days.
During Cycles 1 and 2, the following tests and procedures will be done on days 1 and 15:
- physical exam
- performance status
- blood tests
- pregnancy test (if applicable)
- neuropsychiatric assessments
Starting at Cycle 2 and then every other cycle thereafter (approximately every 8 weeks) tumor assessment will be performed by CT/MRI or PET scan. A chest x-ray will also be performed every 8 weeks.
Beginning with Cycle 3, the following tests/procedures will be performed on Day 1 of each cycle:
- physical exam
- performance status
- blood tests
- neuropsychiatric assessments
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BKM120100 MG PO QD in cycles of 28 days | Drug | – |
Primary outcome
Response Rate
Time frame: 2 years
Objective Response Rate (CR or PR) by RECIST 1.1 criteria
3 secondary outcomes
Clinical Benefit Rate
Time frame: 2 years
Survival
Time frame: 2 years
Clinical Benefit
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey A Engelman, MD, PhD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BKM120 in people with Lung Cancer and Breast Cancer, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2015; AzTrials last refreshed its copy on 1 Nov 2026.