Clinical Trial DRUG CMEK162X2109
- A Phase IB Open-Label, Multi-Center, Dose Escalation and Expansion Study of Orally Administered MEK162 Plus BYl719 in Adult Patients with Selected Advanced Solid Tumors
- Principal Investigator
- Young Kwang Chae
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG CMEK162X2109
- The main purpose of this study is to see what effect, good and/or bad, MEK162 and BYL719 given together has on certain advanced solid tumors.
- This is a phase 1 study which means the investigational drugs (not yet approved by the Food and Drug Administration [FDA]for use in treating this certain disease)have shown promise in animal testing, but have not yet been given together to humans. MEK162 works by blocking (inside the cell) a pathway that is thought to play a part in tumor cell and new blood vessel growth (which supplies blood and oxygen to the tumor). Phosphatidylinositol 3’- kinase (P13K)is a type of enzyme (protein)that is involved in tumor cell growth and multiplication. In many cancers the P13K pathway is always active. BYL719 is new type of drug that works by blocking the P13K pathway. Laboratory studies have shown that the combination of these 2 drugs can lessen tumor growth.
Some of the eligibility criteria include:
- Participants must be 18 years of age or older.
- Participants must have a certain type of advanced solid tumor. Contact the study team for more detailed information regarding this.
- Description of Treatment
- Both BYL719 and MEK162 are taken orally (by mouth). There are different treatment combinations of these drugs. The study doctor will tell you what amount of BYL719 and MEK162 you will take. All participants will receive treatments in cycles. Each cycle is 28 days. Participants will continue treatment until their study doctor thinks it is in their best interest to stop.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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Other Clinical Trials by Young Kwang Chae
- Modular phase II study to link targeted therapy to patients with pathway activated tumors:Module 6 – BGJ398 for patients with tumors with FGFR genetic alterations
- Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 5 - LDE225 for patients with PTCH1 and SMO mutated tumors
- Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 7 – Ceritinib (LDK378) for patients whose tumors have aberrations in ALK or ROS1
- Modular Phase II Study to Link Targeted Therapy to Patients with Pathway Activated Tumors: Module 4 - LGX818 for Patients with BRAFC600 Mutated Tumors
- Modular Phase II Study to Link Targeted Therapy to Patients with Pathway Activated Tumors: Module 3 - MEK162 for Patients with RAS/RAF/MEK Activated Tumors Local
- Modular Phase II Study to Link Targeted Therapy to Patients with Pathway Activated Tumors: Module 2 - Dovitinib for Patients with Tumor Pathway Activations Inhibited by Dovitinib Including Tumors with Mutations or Translocations of FGFR, PDGFR, VEGF, CKIT, FLT3, CSFR1, TRK and RET
- A Phase 1b/2, Open-label Study to Evaluate the Safety and Tolerability of MEDI6469 in Combination with Immune Therapeutic Agents or Therapeutic Monoclonal Antibodies in Subjects with Selected Advanced Solid Tumors or Aggressive B-cell Lymphomas
last updated: 24-Nov-14 03:12 AM
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