Endometrial CancerPhase 2NCT01290406
BEZ235 Trial in Patients With Advanced Endometrial Carcinoma
A Phase 2 study testing BEZ235 in people with Endometrial Cancer, run by Novartis Pharmaceuticals at 59 sites in 12 countries.
Trial summary
This is an open label and single arm study to investigate the safety and efficacy of BEZ235 in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or after first-line antineoplastic treatment for advanced endometrial carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- BEZ235
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 59 sitesin 12 countries
- Study dates
- Mar 2012to Dec 2017
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female ≥ 18 years
- Histological confirmed diagnosis of advanced endometrial carcinoma with available tissue specimen, either archival tissue or fresh formalin fixed tumor biopsy
- Objective and radiologically confirmed progression of disease after prior first-line treatment
- Recovery (to grade ≤ 1) from all clinically significant toxicities related to prior therapies (except alopecia) with adequate bone marrow and organ functions
- At least one measurable lesion as per RECIST
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Who cannot join
- Previous treatment with PI3K and/or mammalian Target Of Rapamycin (mTOR) inhibitors
- More than one line of prior treatment for advanced or metastatic disease
- Active uncontrolled or symptomatic Central Nervous System (CNS) metastases
- Concurrent malignancy or malignancy in the last 3 years prior to start of study treatment
- Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to enrollment in this study
- Active cardiac disease (e.g. Left Ventricular Ejection Fraction (LVEF) < 50%, Q-T interval corrected for heart rate (QTcF) > 480 msec on screening Electrocardiogram (ECG), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias)
Show all 11Show fewer
- Inadequately controlled hypertension
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235
- Drugs with a known risk to induce Torsades de Pointes, moderate and strong inhibitors or inducers of CYP3A4, warfarin and coumadin analogues, Luteinizing Hormone-Releasing Hormone (LHRH) agonists
- Pregnant or nursing (lactating) woman
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
59 sites in 12 countries.
59 sites in 12 countries
United States16 sites
Texas Oncology, P.A.
Austin, Texas
Carolinas Healthcare Systems
Charlotte, North Carolina, 28203
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
GHS
Danville, Pennsylvania
Henry Ford Hospital
Detroit, Michigan, 48202
City of Hope Medical center
Duarte, California, 91010
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Morriswon Memorial Hospital
Morristown, New Jersey, 07960
Sarah Gautam Rau
Nashville, Tennessee, 37203-1197
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73126-0901
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013
Cancer Centers of North Carolina
Raleigh, North Carolina, 27607
STOH
San Antonio, Texas
Pacific Gynecology Specialists
Seattle, Washington, 98104
Holy Cross Hospital
Silver Spring, Maryland, 20910-1484
Cancer Care Northwest
Spokane, Washington, 99202
France10 sites
Novartis Investigative Site
Bordeaux
Novartis Investigative Site
Caen
Novartis Investigative Site
La Roche-sur-Yon
Novartis Investigative Site
Le Mans
Novartis Investigative Site
Lyon
Novartis Investigative Site
Marseille
Novartis Investigative Site
Nice
Novartis Investigative Site
Paris
Novartis Investigative Site
Saint-Brieuc
Novartis Investigative Site
Toulouse
Italy9 sites
Novartis Investigative Site
Aviano
Novartis Investigative Site
Barcelona
Novartis Investigative Site
Bologna
Novartis Investigative Site
Brescia
Novartis Investigative Site
Capmobso
Novartis Investigative Site
Milan
Novartis Investigative Site
Modena
Novartis Investigative Site
Naples
Novartis Investigative Site
Roma
Germany7 sites
Novartis Investigative Site
Berlin
Novartis Investigative Site
Cologne
Novartis Investigative Site
Freiburg im Breisgau
Novartis Investigative Site
Jena
Novartis Investigative Site
Lübeck
Novartis Investigative Site
Mainz
Novartis Investigative Site
München
Canada4 sites
Novartis Investigative Site
Hamilton
Novartis Investigative Site
Montreal
Novartis Investigative Site
Toronto
Novartis Investigative Site
Vancouver
Japan3 sites
Novartis Investigative Site
Aichi
Novartis Investigative Site
Hyōgo
Novartis Investigative Site
Tokyo
Spain3 sites
Novartis Investigative Site
Madrid
Novartis Investigative Site
Oviedo
Novartis Investigative Site
Valencia
Brazil2 sites
Novartis Investigative Site
Rio de Janeiro
Novartis Investigative Site
São Paulo
Poland2 sites
Novartis Investigative Site
Środa Wielkopolska
Novartis Investigative Site
Warzawa
About this study
Official title: A Phase II, Single-arm Study of Orally Administered BEZ235 as Second-line Therapy in Patients With Advanced or Metastatic Endometrial Carcinoma
This is an open label and single arm study to investigate the safety and efficacy of BEZ235 in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or after first-line antineoplastic treatment for advanced endometrial carcinoma.
- Conditions
- Endometrial Cancer
- Being tested
- BEZ235
- Keywords
- Endometrial cancer,, uterine cancer,, PI3K,, mTOR,, targeted therapy
- Medical subject headings
- Endometrial Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEZ235Drug
| Study group | Role | What they receive |
|---|---|---|
| BEZ235 | Experimental | Not described Receives: Drug: BEZ235 |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: every 8 weeks
Secondary outcomes (2)
evaluate additional efficacy parameters (e.g. Disease Control Rate, Progression-Free Survival)
Measured: every 8 weeks
evaluate safety of BEZ235. Safety assessments will include vital signs, laboratory tests, and frequency of adverse events (non-serious and serious).
Measured: Treatment start until 30 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startMar 2012
- Primary completionSep 2014 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT01290406
- Sponsor's protocol ID
- CBEZ235C2201
- Other IDs
- 2010-024396-12, EudraCT 2010-024396-12
- Status last verified
- Jun 2012
- First submitted
- 3 Feb 2011
- Last updated
- 21 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-arm Study of Orally Administered BEZ235 as Second-line Therapy in Patients With Advanced or Metastatic Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT01290406
- Acronym / sponsor ID
- CBEZ235C2201
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial cancer,, uterine cancer,, PI3K,, mTOR,, targeted therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 7 Feb 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.
This is an open label and single arm study to investigate the safety and efficacy of BEZ235 in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or after first-line antineoplastic treatment for advanced endometrial carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BEZ235 | Experimental | Drug: BEZ235 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female ≥ 18 years
- Histological confirmed diagnosis of advanced endometrial carcinoma with available tissue specimen, either archival tissue or fresh formalin fixed tumor biopsy
- Objective and radiologically confirmed progression of disease after prior first-line treatment
- Recovery (to grade ≤ 1) from all clinically significant toxicities related to prior therapies (except alopecia) with adequate bone marrow and organ functions
- At least one measurable lesion as per RECIST
Key exclusion criteria (11 listed)
- Previous treatment with PI3K and/or mammalian Target Of Rapamycin (mTOR) inhibitors
- More than one line of prior treatment for advanced or metastatic disease
- Active uncontrolled or symptomatic Central Nervous System (CNS) metastases
- Concurrent malignancy or malignancy in the last 3 years prior to start of study treatment
- Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to enrollment in this 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 |
|---|---|---|
| BEZ235 | Drug | BEZ235 |
Primary outcome
assess the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: every 8 weeks
2 secondary outcomes
evaluate additional efficacy parameters (e.g. Disease Control Rate, Progression-Free Survival)
Time frame: every 8 weeks
evaluate safety of BEZ235. Safety assessments will include vital signs, laboratory tests, and frequency of adverse events (non-serious and serious).
Time frame: Treatment start until 30 days after the last dose
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 21 Jun 2012.
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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
59 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BEZ235 in people with Endometrial Cancer, run by Novartis Pharmaceuticals at 59 sites in 12 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 6 inclusion and 11 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 21 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, France, Italy, Germany, Canada and 7 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?
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?
assess the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: every 8 weeks). 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 21 Jun 2012.