Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT01337765
Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients
A Phase 1 study testing BEZ235 + MEK162 in people with Unspecified Adult Solid Tumor, Protocol Specific and Solid Tumor, run by Pfizer at 6 sites in 5 countries.
Trial summary
This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in combination with the MEK1/2 inhibitor MEK162. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific, Solid Tumor
- What is being tested?
- BEZ235 + MEK162
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 8 Jul 2011to 22 Mar 2013
- Phase
- Phase 1
- 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
- histologically/cytologically confirmed, advanced non resectable solid tumors
- Measurable or non-measurable, but evaluable disease as determined by RECIST 1.0
Who cannot join
- Patients with primary CNS tumor or CNS tumor involvement
- Diabetes mellitus - Unacceptable ocular/retinal conditions
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
United States2 sites
Massachusetts General Hospital Mass General 2
Boston, Massachusetts, 02114
University of Texas/MD Anderson Cancer Center MD Anderson PSC
Houston, Texas, 77030-4009
About this study
Official title: A Phase Ib, Open-label, Multi-center, Dose-escalation and Expansion Study of an Orally Administered Combination of BEZ235 Plus MEK162 in Adult Patients With Selected Advanced Solid Tumors
This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with EGFR mutant NSCLC which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BEZ235 and MEK162.
Study drugs will be administered orally on a continuous schedule, MEK162 bid and BEZ235 qd, a treatment cycle is defined as 28 days.
- Being tested
- BEZ235 + MEK162
- Keywords
- BEZ235,, MEK162, RAS RAF mutations,, triple negative breast cancer, pancreatic cancer,, NSCLC progressed on EGFR TKI, PI3K/mTOR inhibitor,, MEK inhibitor, Advanced and selected solid tumors
- Medical subject headings
- Triple Negative Breast Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEZ235 + MEK162Drug
| Study group | Role | What they receive |
|---|---|---|
| BEZ235 + MEK162 | Experimental | Not described Receives: Drug: BEZ235 + MEK162 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities
A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination
Measured: during Cycle 1 of treatment with BEZ235 and MEK162
Secondary outcomes (4)
Number of participants with adverse events and serious adverse events
A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination
Measured: from Cycle 1 Day 1 until treatment discontinuation
Overall response rate, duration of response, time to response and progression free survival
Measured: every 8 weeks of treatment
Time versus plasma concentration profiles of BEZ235 and MEK162
A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination
Measured: during the first cycle of treatment
Treatment-induced PI3K and MEK/ERK pathway signaling inhibition and evidence of biological activity in tumor
A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination
Measured: during the first cycle of treatment and at disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study start8 Jul 2011
- Primary completion22 Mar 2013
- Study completion22 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337765
- Sponsor's protocol ID
- CMEK162X2103
- Other IDs
- 2011-000421-74, C4211009
- Status last verified
- Oct 2020
- First submitted
- 2 Apr 2011
- Last updated
- 9 Oct 2020
- Results posted
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-label, Multi-center, Dose-escalation and Expansion Study of an Orally Administered Combination of BEZ235 Plus MEK162 in Adult Patients With Selected Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01337765
- Acronym / sponsor ID
- CMEK162X2103
- Keywords
- BEZ235,, MEK162, RAS RAF mutations,, triple negative breast cancer, pancreatic cancer,, NSCLC progressed on EGFR TKI, PI3K/mTOR inhibitor,, MEK inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2011 (actual)
- Primary completion
- 22 Mar 2013 (actual)
- Study completion
- 22 Mar 2013 (actual)
- First posted
- 19 Apr 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, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with EGFR mutant NSCLC which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BEZ235 and MEK162.
Study drugs will be administered orally on a continuous schedule, MEK162 bid and BEZ235 qd, a treatment cycle is defined as 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BEZ235 + MEK162 | Experimental | Drug: BEZ235 + MEK162 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- histologically/cytologically confirmed, advanced non resectable solid tumors
- Measurable or non-measurable, but evaluable disease as determined by RECIST 1.0
Key exclusion criteria (3 listed)
- Patients with primary CNS tumor or CNS tumor involvement
- Diabetes mellitus - Unacceptable ocular/retinal conditions
- Other protocol-defined inclusion/exclusion criteria may apply
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 + MEK162 | Drug | BEZ235 + MEK162 |
Primary outcome
Incidence of Dose Limiting Toxicities
Time frame: during Cycle 1 of treatment with BEZ235 and MEK162
A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination
4 secondary outcomes
Number of participants with adverse events and serious adverse events
Time frame: from Cycle 1 Day 1 until treatment discontinuation
Overall response rate, duration of response, time to response and progression free survival
Time frame: every 8 weeks of treatment
Time versus plasma concentration profiles of BEZ235 and MEK162
Time frame: during the first cycle of treatment
Treatment-induced PI3K and MEK/ERK pathway signaling inhibition and evidence of biological activity in tumor
Time frame: during the first cycle of treatment and at disease progression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BEZ235 + MEK162 in people with Unspecified Adult Solid Tumor, Protocol Specific and Solid Tumor, run by Pfizer at 6 sites in 5 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 2 inclusion and 3 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 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Australia, Canada, France, Spain. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Dose Limiting Toxicities (time frame: during Cycle 1 of treatment with BEZ235 and MEK162). 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 9 Oct 2020.