CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 6 enrolled
Drug / intervention
Akt Inhibitor MK2206 +1 moredrug
Likely dose
MK-2206 given orally (specific dose not stated in protocol)AI-extracted
Key inclusion· 7
  • Histologically or cytologically confirmed high-grade (grade 2 or 3) serous ovarian, fallopian tube, or primary peritoneal cancer; mixed histology eligible if serous is dominant
  • Measurable disease by RECIST 1.1 criteria
  • Evidence of PI3K/AKT pathway defect: PTEN loss by immunohistochemistry OR PIK3CA/AKT mutation, both in CLIA-certified assay
  • Prior first-line platinum-based chemotherapy
Key exclusion· 8
  • Known brain metastases
  • Prior Akt or PI3K pathway inhibitors including mTOR inhibitors
  • Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry, or unrecovered toxicity >grade 1 from earlier agents
  • Diabetes or hyperglycemia not well controlled; fasting glucose >130 mg/dL or HgbA1c >7.5 mg/dL; insulin-dependent diabetes excluded

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01283035
NCT01283035Phase 2Completed

A Phase II Study of MK-2206 in the Treatment of Recurrent High-Grade Serous Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

National Cancer Institute (NCI)·interventional·Posted Jan 25, 2011·Updated Jun 24, 2016

In Brief

A Phase 2 clinical trial evaluating Akt Inhibitor MK2206 and Laboratory Biomarker Analysis for Ovarian Sarcoma and 3 related conditions. Completed, enrolled 6 participants across 6 sites.

Detailed Summary

Akt inhibitor MK2206 is a drug that may stop cancer cells from growing by blocking a protein called protein kinase B (AKT) inside the cell. AKT interacts with other proteins in the cell that are part of the P13K/AKT pathway, a pathway that is know to play a role in the growth of cancer cells. Mutations in P13K or in AKT, or changes in another protein called phosphatase and tensin homolog (PTEN) in this pathway can lead it to become more active than is normal. This study investigates how effective MK-2206 is in treating ovarian, fallopian tube, or primary peritoneal cancer where there are mutations in P13K or AKT or low levels of PTEN.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 25, 2011
Enrollment StartApr 1, 2011
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 15.4 years ago

Interventions

Akt Inhibitor MK2206drug

Given PO

Laboratory Biomarker Analysisother

Correlative studies