CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 52 enrolled
Drug / intervention
vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatindrug
Likely dose
Vorinostat 200 mg orally twice daily in combination with pemetrexed and cisplatinAI-extracted
Key inclusion· 5
  • ✓Age ≥18 years
  • ✓Confirmed solid tumor diagnosis for which pemetrexed and cisplatin is acceptable treatment
  • ✓No more than 2 prior systemic therapies
  • ✓At least 1 measurable lesion
Key exclusion· 7
  • ✕Prior treatment with other investigational agents with similar anti-tumor mechanism
  • ✕Prior pemetrexed or cisplatin within 6 months (cohorts A/B); prior pemetrexed within 6 months (cohorts C/D)
  • ✕Grade 2 or higher neuropathy (cohorts A/B); Grade 3 or higher neuropathy (cohorts C/D)
  • ✕Active infection or IV antibiotic/antiviral/antifungal within 2 weeks of study start

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

Search/NCT00106626
NCT00106626Phase 1Completed
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Phase I Clinical Trial of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Pemetrexed and Cisplatin in Patients With Advanced Cancer

Merck Sharp & Dohme LLC·interventional·Posted Mar 29, 2005·Updated Apr 22, 2009

In Brief

A Phase 1 clinical trial evaluating vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin for Advanced Cancer. Completed, enrolled 52 participants.

Detailed Summary

The purpose of this investigational study is to determine the safety and tolerability of oral suberoylanilide hydroxamic acid when administered in combination with standard doses of pemetrexed and cisplatin for the treatment of advanced solid tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Cancer
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 29, 2005
Enrollment StartAug 1, 2005
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 21.3 years ago

Interventions

vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatindrug

Dose escalation study starting with vorinostat (Suberoylanilide Hydroxamic Acid \[SAHA\]) capsules 200 mg b.i.d. in combination with Pemetrexed and Cisplatin (see table for Reporting Groups).