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Developmental therapeutics

1335 - Phase I dose escalation study of M2698, a p70S6K/AKT inhibitor, in patients with advanced cancer

Date

09 Sep 2017

Session

Developmental therapeutics

Topics

Clinical Research

Presenters

A Tsimberidou

Citation

Annals of Oncology (2017) 28 (suppl_5): v122-v141. 10.1093/annonc/mdx367

Authors

A.M. Tsimberidou1, C. Verschraegen2, A. Weise3, J. Sarantopoulos4, G. Lopes5, J. Nemunaitis6, A. Victor7, J. Shaw8, R. Kaleta8, R. Kurzrock9

Author affiliations

  • 1 Investigational Cancer Therapeutics, MD Anderson Cancer Center, TX77030 - Houston/US
  • 2 Division Of Medical Oncology, Ohio State Unv. Medical Center, Columbus/US
  • 3 Medical Oncology, Karmanos Cancer Institute, Detroit/US
  • 4 Institute For Drug Development, Cancer Therapy and Research Center at University of Texas Health Science Center, San Antonio/US
  • 5 Clinical Medicine, Sylvester Comprehensive Cancer Center, Miami/US
  • 6 Medical Oncology, Mary Crowley Cancer Research Center, Dallas/US
  • 7 Global Biostatistics, Merck KGaA, Darmstadt/DE
  • 8 Clinical Oncology, EMD Serono, Billerica/US
  • 9 Clinical Science, UCSD Moores Cancer Center, La Jolla/US
More

Resources

Abstract 1335

Background

Aberrant PI3K/Akt/mTOR (PAM) pathway signaling is observed in various tumors and confers resistance to standard therapies. M2698 is an oral, brain penetrant, potent and selective p70S6K/Akt1/3 inhibitor that can block signaling from Akt feedback loop activation, a possible tumor escape mechanism

Methods

Patients (pts) with advanced cancer were given oral M2698 daily (PO 15–380 mg) in 21-day (d) cycles in a 3 + 3 dose escalation [DE] design. Response was assessed every 2 cycles. An expansion phase in pts with PAM pathway tumor alterations is ongoing

Results

Overall, 50 pts received M2698 monotherapy (DE, n = 40; expansion, n = 10); DE data presented only (cut-off 10/27/16). Treated pts had a median age of 56 years. (14 men, 26 women). Tumor types included breast (n = 7), colon (n = 4), lung (n = 4) and other (n = 25). In the DE phase, 35/40 pts were evaluable. Two pts had a dose limiting toxicity (DLT; 60mg and 160mg) and drug-related Grade ≥3 adverse events (AEs) occurred in 6/40 (15%) of pts. AEs leading to dose reductions occurred in 1 pt at 

Conclusions

M2698 was well tolerated and provided stable disease over a wide range of doses.

Clinical trial identification

NCT01971515

Legal entity responsible for the study

Merck KGaA, Darmstadt, Germany

Funding

Merck KGaA, Darmstadt, Germany

Disclosure

G. Lopes, R. Kurzrock: Research funding from Merck. A. Victor: Merck employee. J. Shaw, R. Kaleta: EMD Serono employee. All other authors have declared no conflicts of interest.

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