Advanced Endometrial CancerPhase 2NCT01289041
BKM120 as Second-line Therapy for Advanced Endometrial Cancer
A Phase 2 study testing BKM120 in people with Advanced Endometrial Cancer, run by Novartis Pharmaceuticals at 42 sites in 13 countries.
Trial summary
This is a prospective multi-center, open-label, single arm, Phase II study to investigate the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120 orally at a dose of 100 mg/day. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Endometrial Cancer
- What is being tested?
- BKM120
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 42 sitesin 13 countries
- Study dates
- Feb 2011to Mar 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
- histologically confirmed diagnosis of advanced endometrial carcinoma with available tissue specimen for identification of PI3K pathway activation (archival tissue or a fixed fresh biopsy)
- one prior line of antineoplastic treatment with a cytotoxic agent
- objective progression of disease after prior treatment and at least one measurable lesion as per RECIST criteria
- adequate bone marrow and organ function
Who cannot join
- previous treatment with PI3K and/or mTOR inhibitors
- symptomatic CNS metastases
- concurrent malignancy or malignancy within 3 years of study enrollment
- Active mood disorder as judged by investigator or medically documented history of mood disorder (e.g. major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, etc.), ≥ CTCAE grade 3 anxiety
- pelvic and/or para-aortic radiotherapy ≤ 28 days prior to enrollment in the study
- poorly controlled diabetes mellitus (HbA1c > 8 %)
Show all 9Show fewer
- history of cardiac dysfunction or active cardiac disease as specified in the protocol
- impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
42 sites in 13 countries.
42 sites in 13 countries
United States9 sites
Texas Oncology, P.A. Austin
Bedford, Texas, 76022
Carolinas HealthCare Systems Blumenthal Cancer Center
Charlotte, North Carolina, 28207
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, 72703
Morristown Memorial Hospital MMH
Morristown, New Jersey, 07962
Sarah Cannon Research Institute SCRI (2)
Nashville, Tennessee, 37203
University of Oklahoma Health Sciences Center OU Health
Oklahoma City, Oklahoma, 73104
St. Joseph's Hospital & Medical Center St Joseph's
Phoenix, Arizona, 85013
South Texas Oncology and Hematology, PA South Tex Onc
San Antonio, Texas, 78258
Cancer Care Northwest CC Northwest- Spokane South(3)
Spokane, Washington, 99202
Italy5 sites
Novartis Investigative Site
Aviano, PN, 33081
Novartis Investigative Site
Bologna, 40138
Novartis Investigative Site
Milan, MI, 20141
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Roma, RM, 00168
Spain5 sites
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Madrid, 28033
Novartis Investigative Site
Madrid, 28046
Novartis Investigative Site
Valencia, Valencia, 46009
Novartis Investigative Site
Valencia, Valencia, 46026
Canada4 sites
Novartis Investigative Site
Hamilton, Ontario, L8V 5C2
Novartis Investigative Site
Montreal, Quebec, H2L 4M1
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
Novartis Investigative Site
Vancouver, British Columbia, V5Z 4E6
France4 sites
Novartis Investigative Site
Le Mans, 72015
Novartis Investigative Site
Lyon, 69373
Novartis Investigative Site
Nice, 06189
Novartis Investigative Site
Toulouse, 31059
Germany4 sites
Novartis Investigative Site
Berlin, 10367
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Cologne, 50937
Novartis Investigative Site
Mainz, 55131
Belgium3 sites
Novartis Investigative Site
Leuven, 3000
Novartis Investigative Site
Liège, 4000
Novartis Investigative Site
Wilrijk, 2610
Japan3 sites
Novartis Investigative Site
Chuo-ku, Tokyo, 104-0045
Novartis Investigative Site
Minato-ku, Tokyo, 105-8471
Novartis Investigative Site
Nagoya, Aichi-ken, 464-8681
Brazil1 site
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 20220410
About this study
Official title: A Phase II, Single-arm Study of Orally Administered BKM120 as Second-line Therapy in Patients With Advanced Endometrial Carcinoma
This is a prospective multi-center, open-label, single arm, Phase II study to investigate the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120 orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase (PI3K) pathway activation status.
- Conditions
- Advanced Endometrial Cancer
- Being tested
- BKM120
- Keywords
- Advanced endometrial cancer, PI3K pathway, second-line treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BKM120Drug
Also called Buparlisib
| Study group | Role | What they receive |
|---|---|---|
| All Patients | Experimental | Not described Receives: Drug: BKM120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status
BOR was determined based on investigator assessment of overall lesion response using RECIST criteria guidelines. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: 24 months
Secondary outcomes (2)
Progression Free Survival (PFS) According to PI3K Activation Pathway Status
PFS is defined as the time from start of treatment to the date of first documented progression or death due to any cause. If a patient has not had an event, PFS will be censored at the date of last adequate tumor assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 24 months
Overall Survival (OS) According to PI3K Activation Pathway Status
Overall survival (OS) was defined as the time from start of treatment to the date of death due to any cause. If a patient is not known to have died, survival was censored at the last date of contact. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289041
- Sponsor's protocol ID
- CBKM120C2201
- Other IDs
- 2010-022015-19
- Status last verified
- May 2019
- First submitted
- 26 Jan 2011
- Last updated
- 30 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-arm Study of Orally Administered BKM120 as Second-line Therapy in Patients With Advanced Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT01289041
- Acronym / sponsor ID
- CBKM120C2201
- Conditions
- Advanced Endometrial Cancer
- Keywords
- Advanced endometrial cancer, PI3K pathway, second-line treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 3 Feb 2011 (estimated)
- Results
- Posted 10 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective multi-center, open-label, single arm, Phase II study to investigate the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120 orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase (PI3K) pathway activation status.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Patients | Experimental | Drug: BKM120 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
- histologically confirmed diagnosis of advanced endometrial carcinoma with available tissue specimen for identification of PI3K pathway activation (archival tissue or a fixed fresh biopsy)
- one prior line of antineoplastic treatment with a cytotoxic agent
- objective progression of disease after prior treatment and at least one measurable lesion as per RECIST criteria
- adequate bone marrow and organ function
Key exclusion criteria (9 listed)
- previous treatment with PI3K and/or mTOR inhibitors
- symptomatic CNS metastases
- concurrent malignancy or malignancy within 3 years of study enrollment
- Active mood disorder as judged by investigator or medically documented history of mood disorder (e.g. major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, etc.), ≥ CTCAE grade 3 anxiety
- pelvic and/or para-aortic radiotherapy ≤ 28 days prior to enrollment in the study
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 |
|---|---|---|
| BKM120Also: Buparlisib | Drug | All Patients |
Primary outcome
Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status
Time frame: 24 months
BOR was determined based on investigator assessment of overall lesion response using RECIST criteria guidelines. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
2 secondary outcomes
Progression Free Survival (PFS) According to PI3K Activation Pathway Status
Time frame: 24 months
Overall Survival (OS) According to PI3K Activation Pathway Status
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
42 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BKM120 in people with Advanced Endometrial Cancer, run by Novartis Pharmaceuticals at 42 sites in 13 countries.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Italy, Spain, Canada, France and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 10 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status (time frame: 24 months). 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 30 May 2019.