Advanced Solid TumorsPhase 1NCT01363232
Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients
A Phase 1 study testing BKM120 + MEK162 in people with Advanced Solid Tumors and Selected Solid Tumors, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 12 sites in 7 countries.
Trial summary
This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 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
- Advanced Solid Tumors, Selected Solid Tumors
- What is being tested?
- BKM120 + MEK162
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 12 sitesin 7 countries
- Study dates
- Aug 2011to 18 Dec 2017
- 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
Who cannot join
- Patients with primary CNS tumor or CNS tumor involvement.
- Diabetes mellitus
- Unacceptable ocular/retinal conditions
Trial locations and contacts
12 sites in 7 countries.
12 sites in 7 countries
United States5 sites
Massachusetts General Hospital Mass General 2
Boston, Massachusetts, 02115
Karmanos Cancer Institute Study Coordinator
Detroit, Michigan, 48201
Cancer Centers of the Carolinas CCC Faris
Greenville, South Carolina, 29605
University of Texas/MD Anderson Cancer Center MD Anderson PSC
Houston, Texas, 77030-4009
Memorial Sloan Kettering Cancer Center MSKCC (2)
New York, New York, 90033
Germany2 sites
Pfizer Investigative Site
Essen, 45147
Pfizer Investigative Site
Heidelberg, 69120
About this study
Official title: A Phase Ib, Open-label, Multi-center, Dose-escalation and Expansion Study of an Orally Administered Combination of BKM120 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 the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (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 BKM120 and MEK162.
Study drugs will be administered once daily orally on a continuous schedule. A treatment cycle is defined as 28 days.
- Conditions
- Advanced Solid Tumors, Selected Solid Tumors
- Being tested
- BKM120 + MEK162
- Keywords
- BKM120, MEK162, RAS RAF mutations, triple negative breast cancer, pancreatic cancer, ovarian cancer, NSCLC progressed on EGFR TKI, PI3K inhibitor, MEK inhibitor
- Medical subject headings
- Triple Negative Breast Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BKM120 + MEK162Drug
| Study group | Role | What they receive |
|---|---|---|
| BKM120 + MEK162 | Experimental | Not described Receives: Drug: BKM120 + MEK162 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities
Measured: during Cycle 1 of treatment with BKM120 and MEK162
Secondary outcomes (4)
Number of participants with adverse events and serious adverse events.
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 BKM120 and MEK162
Measured: during the first cycle of treatment on Cycle 1 Day 1 and Cycle 1 Day 15
Treatment -induced PI3K and MEK/ERK pathway signaling inhibition and evidence of biological activity in tumor.
Measured: during the first cycle of treatment on Cycle 1 Day 15 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 posted1 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2014
- Study completion18 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- 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
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, 1-800-718-1021Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363232
- Sponsor's protocol ID
- CMEK162X2101
- Other IDs
- 2011-001083-22
- Status last verified
- Sep 2020
- First submitted
- 24 May 2011
- Last updated
- 5 Oct 2020
- Results posted
- No
Publications
Bardia A, Gounder M, Rodon J, Janku F, Lolkema MP, Stephenson JJ, Bedard PL, Schuler M, Sessa C, LoRusso P, Thomas M, Maacke H, Evans H, Sun Y, Tan DSW. Phase Ib Study of Combination Therapy with MEK Inhibitor Binimetinib and Phosphatidylinositol 3-Kinase Inhibitor Buparlisib in Patients with Advanced Solid Tumors with RAS/RAF Alterations. Oncologist. 2020 Jan;25(1):e160-e169. doi: 10.1634/theoncologist.2019-0297. Epub 2019 Aug 8.
PubMed 31395751
Study at a glance
From the registry record, last updated by the sponsor on 5 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 BKM120 Plus MEK162 in Adult Patients With Selected Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01363232
- Acronym / sponsor ID
- CMEK162X2101
- Conditions
- Advanced Solid Tumors, Selected Solid Tumors
- Keywords
- BKM120, MEK162, RAS RAF mutations, triple negative breast cancer, pancreatic cancer, ovarian cancer, NSCLC progressed on EGFR TKI, PI3K inhibitor, MEK inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 1 Jun 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 the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (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 BKM120 and MEK162.
Study drugs will be administered once daily orally on a continuous schedule. 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 |
|---|---|---|
| BKM120 + MEK162 | Experimental | Drug: BKM120 + 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
Key exclusion criteria (3 listed)
- Patients with primary CNS tumor or CNS tumor involvement.
- Diabetes mellitus
- Unacceptable ocular/retinal conditions
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 |
|---|---|---|
| BKM120 + MEK162 | Drug | BKM120 + MEK162 |
Primary outcome
Incidence of Dose Limiting Toxicities
Time frame: during Cycle 1 of treatment with BKM120 and MEK162
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 BKM120 and MEK162
Time frame: during the first cycle of treatment on Cycle 1 Day 1 and Cycle 1 Day 15
Treatment -induced PI3K and MEK/ERK pathway signaling inhibition and evidence of biological activity in tumor.
Time frame: during the first cycle of treatment on Cycle 1 Day 15 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 5 Oct 2020.
- Derived from this study: PubMed 31395751Bardia A, Gounder M, Rodon J, Janku F, Lolkema MP, Stephenson JJ, Bedard PL, Schuler M, Sessa C, LoRusso P, Thomas M, Maacke H, Evans H, Sun Y, Tan DSW. Phase Ib Study of Combination Therapy with MEK Inhibitor Binimetinib and Phosphatidylinositol 3-Kinase Inhibitor Buparlisib in Patients with Advanced Solid Tumors with RAS/RAF Alterations. Oncologist. 2020 Jan;25(1):e160-e169. doi: 10.1634/theoncologist.2019-0297. Epub 2019 Aug 8.
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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
1-800-718-1021
Pfizer CT.gov Call Center study director
Pfizer
12 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BKM120 + MEK162 in people with Advanced Solid Tumors and Selected Solid Tumors, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 12 sites in 7 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 5 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 12 sites in United States, Germany, Canada, Netherlands, Singapore and 2 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 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 BKM120 and MEK162). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01363232, which also lists 1 linked publication.
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 5 Oct 2020.