Clinical Trials Logo

Clinical Trial Summary

This phase II trial studies how well selumetinib and Akt inhibitor MK2206 works in treating patients with stage III or stage IV melanoma who failed prior therapy with vemurafenib or dabrafenib. Selumetinib and Akt inhibitor MK2206 stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether giving selumetinib and Akt inhibitor MK2206 together is an effective treatment for advanced melanoma.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the frequency of objective clinical responses by RECIST 1.1 for these melanoma patients who have previously progressed on selective BRAF inhibitors when treated with MEK inhibitor, AZD6244 hydrogen sulfate plus Akt inhibitor, MK-2206.

II. To further characterize toxicities of both regimens in these patients who have progressed after BRAF inhibitor therapy.

SECONDARY OBJECTIVES:

I. With required fresh pretreatment biopsies on all patients, we plan to characterize the molecular state (genetic and proteomic) associated with BRAF inhibitor resistance. This may include an analysis of pathway activation, PI3/Akt or MAP kinase pathway; loss of expression of PTEN, secondary mutations in BRAF, other mutations in the MAP kinase pathway (NRAS, KRAS, HRAS, CRAF, MEK), activation of other RTKs (amplification, over expression, phosphorylation).

OUTLINE:

Patients receive selumetinib orally (PO) twice daily (BID) on days 1-21 and Akt inhibitor MK2206 PO once weekly.

After completion of study treatment, patients are followed up every 12 weeks. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01519427
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Terminated
Phase Phase 2
Start date January 2012
Completion date May 2013

See also
  Status Clinical Trial Phase
Completed NCT02107755 - Stereotactic Radiation Therapy and Ipilimumab in Treating Patients With Metastatic Melanoma Phase 2
Withdrawn NCT01216787 - RO4929097 in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma That Can Be Removed by Surgery Phase 2
Active, not recruiting NCT01026324 - Dinaciclib in Treating Patients With Stage III-IV Melanoma Phase 1/Phase 2
Completed NCT01010984 - LC Bead Embolization Agent With Doxorubicin in the Treatment Liver Metastasis From Melanoma N/A
Completed NCT00553306 - Laboratory-Treated T Cells and Aldesleukin After Cyclophosphamide in Treating Patients With Stage IV Melanoma Phase 1/Phase 2
Completed NCT00121225 - Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma Phase 2
Completed NCT00019448 - Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma Phase 2
Active, not recruiting NCT03200847 - Pembrolizumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma Phase 1/Phase 2
Active, not recruiting NCT03235245 - Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib Phase 2
Terminated NCT01875653 - Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma Phase 3
Completed NCT01748747 - Vaccine Therapy and Resiquimod in Treating Patients With Stage II-IV Melanoma That Has Been Removed By Surgery Early Phase 1
Terminated NCT01316692 - Aurora A Kinase Inhibitor MLN8237 in Treating Patients With Unresectable Stage III-IV Melanoma Phase 2
Active, not recruiting NCT01120275 - Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Stage IV Melanoma Phase 2
Terminated NCT01026051 - Safety, Immune and Tumor Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With Melanoma Phase 2
Terminated NCT01217411 - RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer Phase 1
Terminated NCT01166126 - Temsirolimus/AZD 6244 for Treatment-naive With BRAF Mutant Unresectable Stage IV Phase 2
Completed NCT01037790 - Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer Phase 2
Completed NCT00288041 - Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Metastatic Melanoma Phase 2
Completed NCT00072163 - Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma Phase 2
Completed NCT00074308 - Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers Phase 1/Phase 2