Antineoplastic Agents

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Vorinostat

Histone Deacetylase Inhibitors

Enzyme Inhibitors

A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat 800 mg capsules (Period 1) crossing over to Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1) crossing over to Single dose of vorinostat 800 mg capsules (Period 2). Part 2: All patients will receive 400 mg vorinostat capsules once daily. Treatment will continue until disease progression or intolerable toxicity.

vorinostat

A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1).

Comparator: placebo (unspecified)

Medical Monitor

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

Merck Duration of Treatment : vorinostat; treatment will continue until disease progression or intolerable toxicity is reached

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

A Randomized, Partially-Blind, Placebo-Controlled, 2-Period Crossover Study to Assess the Effects of a Single Dose of Vorinostat on the QTc Interval in Patients With Advanced Cancer

The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.

Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.

The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The placebo-corrected change from baseline in QTcF was calculated by subtracting the QTcF change from baseline for placebo at each timepoint from the QTcF change from baseline for vorinostat at each timepoint.

Merck Sharp & Dohme LLC

All Participants group includes data from all participants throughout Part 1 and Part 2 of the study.

All Participants

Age, Continuous

Sex: Female, Male

Asian

Black

Hispanic

White

Race/Ethnicity, Customized

Ovarian

Colon

Lung

Mesothelioma

Uterine

Soft Tissue

Anal

Basocellular

Breast

Gastrointestinal

Mucinous carcinoma

Pancreatic

Thyroid

Cancer Type

0 = Normal Activity

1 = Symptoms, but ambulatory

2 = In bed <50% of the time

ECOG Scale: 0 = Normal Activity, 1 = Symptoms, but ambulatory, 2 = In bed \<50% of the time, 3 = In bed \>50% of the time, 4 = 100% Bedridden, 5 = Dead

Eastern Cooperative Oncology Group (ECOG) Performance Status

None

One Prior Radiation Therapy

Two Prior Radiation Therapies

Three or More Prior Radiation Therapies

Number of Prior Radiation Therapies

One Prior Systemic Anti-Cancer Therapy

Two Prior Systemic Anti-Cancer Therapies

Three or more Prior Systemic Anti-Cancer Therapies

Number of Prior Systemic Anti-Cancer Therapies

Senior Vice President, Global Clinical Development

Placebo

All patients as treated population in Part 1 of the Study;

22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)

Change From Baseline in QTcF at 0.5 Hours

Change From Baseline in QTcF at 1 Hour

Change From Baseline in QTcF at 2 Hours

Change From Baseline in QTcF at 3 Hours

Change From Baseline in QTcF at 4 Hours

Change From Baseline in QTcF at 8 Hours

Change From Baseline in QTcF at 12 Hours

Change From Baseline in QTcF at 24 Hours

Single dose 800 mg vorinostat in Period 1 followed by a three day wash out period, then matching placebo in Period 2. Following the last dose of study drug, there was a minimum 5 day washout before entering Part 2.

Vorinostat Then Placebo: Part 1

Single dose matching placebo in Period 1 followed by a three day wash out period, then single dose 800 mg vorinostat in Period 2. Following the last dose of study drug, there was a minimum 5 day washout before entering Part 2.

Placebo Then Vorinostat: Part 1

Vorinostat 400 mg once daily.

Ten participants changed dosage to vorinostat 300 mg daily during Part 2.

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

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