CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 77 enrolled
Drug / intervention
MK-2206 +5 moredrug
Likely dose
MK-2206 30–250 mg PO on Days 1/3/5/7 or Day 1 of 21-day cycle (depending on schedule) in combination with docetaxel, carboplatin/paclitaxel, erlotinib, or corticosteroidsAI-extracted
Key inclusion· 5
  • ✓Locally advanced or metastatic solid tumors
  • ✓Age ≥18 years
  • ✓ECOG performance status ≤1
  • ✓Able to swallow capsules with no anatomical condition preventing swallowing
Key exclusion· 15
  • ✕Active CNS metastases or carcinomatous meningitis
  • ✕Primary CNS tumor
  • ✕Chemotherapy, radiotherapy, or biological therapy within 4 weeks
  • ✕Known hypersensitivity to study drug components

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

Search/NCT00848718
NCT00848718Phase 1Completed
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A Phase I Dose Escalation Study of MK-2206 in Combination With Standard Doses of Selected Chemotherapies or Targeted Agents in Patients With Locally Advanced or Metastatic Solid Tumors

Merck Sharp & Dohme LLC·interventional·Posted Feb 20, 2009·Updated Nov 12, 2019

In Brief

A Phase 1 clinical trial evaluating MK-2206, docetaxel, and 4 other interventions for Locally Advanced, Metastatic Solid Tumors. Completed, enrolled 77 participants.

Detailed Summary

The purpose of this study is to compare the safety and tolerability of several dose levels of MK-2206 in combination with chemotherapy and targeted therapy agents in participants with locally advanced or metastatic solid tumors. The primary hypotheses are that administration of MK-2206 in combination with either carboplatin + paclitaxel, docetaxel, or erlotinib in participants with locally advanced or metastatic solid tumors will have acceptable tolerability, a dose limiting toxicity (DLT) rate of ≤30%, plasma exposure and pharmacodynamics that exceed target thresholds, and allow for definition of a maximum tolerated dose (MTD) in each of the 3 combinations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLocally Advanced, Metastatic Solid Tumors
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 20, 2009
Enrollment StartMar 17, 2009
Primary CompletionMay 19, 2011
Study CompletionMay 17, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.4 years ago

Interventions

MK-2206drug

MK-2206 given by mouth (PO) on Days 1, 3, 5, and 7 of each 21-day cycle (30 mg, 45 mg, or 60 mg) OR MK-2206 PO on Day 1 of each 21-day cycle (60 mg, 90 mg, 135 mg, 200 mg , or 250 mg)

docetaxeldrug

Administered as an IV infusion on Day 1 of each 21-day cycle

erlotinibdrug

Administered daily (QD) PO in each 21-day cycle

carboplatindrug

Administered as an intravenous (IV) infusion on Day 1 of every 21-day cycle

paclitaxeldrug

Administered as an intravenous (IV) infusion on Day 1 of every 21-day cycle

corticosteroiddrug

Administered PO twice a day (BID) on Days 1-3 of each 21-day cycle