Phase 1 Completed N=25 Randomized Single-blind Treatment

A Crossover Study to Assess the Effects of Vorinostat (MK0683, SAHA) in Patients With Advanced Cancer (0683-070)(COMPLETED)

Advanced Cancer Relapsed · Advanced Cancer Refractory

Source: ClinicalTrials.gov NCT00632931 ↗

Enrolled (actual)

Serious AEs

44.0%

Results posted

Feb 2010

Primary outcomePrimary: Change From Baseline in QTcF at 0.5 Hours — 1.78; -1.22 milliseconds

Summary

A 2-period, crossover study to assess the effects of MK0683 (vorinostat) on the QTc interval in patients with relapsed or refractory advanced cancer.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in QTcF at 0.5 Hours	1.78; -1.22	—
PRIMARY Change From Baseline in QTcF at 1 Hour	0.22; -1.23	—
PRIMARY Change From Baseline in QTcF at 2 Hours	1.09; -1.98	—
PRIMARY Change From Baseline in QTcF at 3 Hours	1.32; -1.52	—
PRIMARY Change From Baseline in QTcF at 4 Hours	4.95; -1.49	—
PRIMARY Change From Baseline in QTcF at 8 Hours	-3.56; -7.89	—
PRIMARY Change From Baseline in QTcF at 12 Hours	1.35; -1.31	—
PRIMARY Change From Baseline in QTcF at 24 Hours	1.53; -4.89	—

Eligibility Criteria

Inclusion Criteria

Patient has a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy or for which standard therapy does not exist
Patient has life expectancy of greater than 3 months
Patient is able to swallow capsules

Exclusion Criteria

Patient has had chemotherapy, radiotherapy or biological therapy 2 weeks prior to taking study drug
Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent
Patient has active CNS metastases and/or carcinomatous meningitis
Patient has primary central nervous system tumor
Patient has a history of drug or alcohol abuse
Patient has Hepatitis B or C
Patient is HIV positive
Patient has active infection or has received intravenous antibiotics, antiviral or antifungal agents 2 weeks before taking study drug

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00632931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.