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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001083-22 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BKM120 + MEK162 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BKM120 + MEK162 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicities | during Cycle 1 of treatment with BKM120 and MEK162 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events and serious adverse events. | from Cycle 1 Day 1 until treatment discontinuation | |
| Overall response rate, duration of response, time to response and progression free survival | every 8 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | 1-800-718-1021 | Study Director |
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Mass General 2 | Boston | Massachusetts | 02115 | United States | ||
| Karmanos Cancer Institute Study Coordinator |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31395751 | Derived | 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. |
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| Time versus plasma concentration profiles of BKM120 and MEK162 | 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. | during the first cycle of treatment on Cycle 1 Day 15 and at disease progression |
| Detroit |
| Michigan |
| 48201 |
| United States |
| Memorial Sloan Kettering Cancer Center MSKCC (2) | New York | New York | 90033 | United States |
| Cancer Centers of the Carolinas CCC Faris | Greenville | South Carolina | 29605 | United States |
| University of Texas/MD Anderson Cancer Center MD Anderson PSC | Houston | Texas | 77030-4009 | United States |
| Pfizer Investigative Site | Toronto | Ontario | M5G 2M9 | Canada |
| Pfizer Investigative Site | Essen | 45147 | Germany |
| Pfizer Investigative Site | Heidelberg | 69120 | Germany |
| Pfizer Investigative Site | Utrecht | 3584CX | Netherlands |
| Pfizer Investigative Site | Singapore | 169610 | Singapore |
| Pfizer Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Pfizer Investigative Site | Bellinzona | 6500 | Switzerland |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C571178 | NVP-BKM120 |
| C581313 | binimetinib |
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