Antineoplastic Agents

All Drugs and Chemicals

Vorinostat

Histone Deacetylase Inhibitors

Enzyme Inhibitors

During Cycle 1, participants receive a single oral dose of vorinostat 100 mg on Day 1 in a fasted state, Day 3 in a fed state, and Day 19 in a fed state. On Days 5-18, participants receive vorinostat 100 mg twice daily, in the morning and evening. If participants do not match to the discontinuation criteria, they can continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle will be 26 days.)

During Cycle 1, participants receive a single oral dose of vorinostat 200 mg on Day 1 in a fasted state; on Day 3 in a fed state; and on Day 19 in a fed state. On Days 5-18, participants receive vorinostat 200 mg twice daily, in the morning and evening. If participants do not match to the discontinuation criteria, they can continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle will be 26 days.)

During Cycle 1, participants receive a single oral dose of vorinostat 400 mg on Day 1 in a fasted state; on Day 3 in a fed state; and on Day 19 in a fed state. On Days 5-18, participants receive a single oral dose of vorinostat 400 mg once-daily in the morning. If participants do not match to the discontinuation criteria, they can continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle will be 26 days.)

During Cycle 1, participants receive a single oral dose of vorinostat 500 mg on Day 1 in a fasted state; on Day 3 in a fed state; and on Day 19 in a fed state. On Days 5-18, participants receive a single oral dose of vorinostat 500 mg once-daily in the morning. If participants do not match to the discontinuation criteria, they can continue the same dose level therapy on the Cycle 2 and subsequent cycles.(Each cycle will be 26 days.)

vorinostat 100 mg, 200 mg, 400 mg, or 500 mg single oral dose; once-daily or twice-daily administration

vorinostat

Medical Director

The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral suberoylanilide hydroxamic acid in participants with solid tumors.

A Study of Vorinostat in Patients With Solid Tumors (MK-0683-029)

A Phase I Clinical Study of L-001079038 in Patients With Solid Tumors

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

A DLT was defined as an event considered to be related to study treatment and included: 1) Grade 4 neutropenia refractory to treatments persisting more than 5 days; 2) Grade 3 or more severe neutropenic fever; 3) Grade 3 thrombocytopenia requiring blood transfusions or Grade 4 thrombocytopenia; 4) Grade 4 hemoglobin decrease; 5) Grade 3 or more severe non-hematological toxicities other than anorexia, nausea/vomiting, and fatigue. (For the diarrhea, it was defined as not to use the frequency for the grading. For the alanine aminotransferase \[ALT\]/aspartate aminotransferase \[AST\]), it was defined as the case of over 300 IU/L; 6) Grade 3 or more severe anorexia, nausea/vomiting, and fatigue refractory to treatments; and 7) compliance of the study drug, while administrating 14 consecutive days, was less than 50% due to the drug-related adverse experience.

AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.

Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.

Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.

t½ is the elimination half-life of study drug. t½ is the time it takes for half of the study drug in the blood plasma to dissipate.

Merck Sharp & Dohme LLC

Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study treatment. All-Cause Mortality: All participants included in a treatment group at enrollment, regardless of treatment duration. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.)

During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)

Vorinostat 100 mg

During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)

Vorinostat 200 mg

During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.)

Vorinostat 400 mg

During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.)

Vorinostat 500 mg

During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles.(Each cycle was 26 days.)

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Senior Vice President, Global Clinical Development

All participants who received at least one dose of study drug. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.)

Number of Participants Who Experienced One or More Adverse Events

Number of Participants Who Discontinued Study Treatment Due to an Adverse Event

During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. (Cycle 1 was 26 days.)

During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. (Cycle 1 was 26 days.)

During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. (Cycle 1 was 26 days.)

During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. (Cycle 1 was 26 days.)

All participants who received at least one dose of study drug

Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1

Participants received a single oral dose of vorinostat 100 mg in fasted state on Day 1.

Vorinostat 100 mg FASTED

Participants received a single oral dose of vorinostat 200 mg in fasted state on Day 1.

Vorinostat 200 mg FASTED

Participants received a single oral dose of vorinostat 400 mg in fasted state on Day 1.

Vorinostat 400 mg FASTED

Participants received a single oral dose of vorinostat 500 mg in fasted state on Day 1.

Vorinostat 500 mg FASTED

All participants who complied with the protocol and had Day 1 pharmacokinetic (PK) data for AUC0-inf.

Area Under the Plasma Concentration Time Curve From Hour 0 to Infinity (AUC0-inf) of Vorinostat After a Single Oral Dose in a Fasted State

Participants received a single oral dose of vorinostat 100 mg in a fed state on Day 3.

Vorinostat 100 mg FED

Participants received a single oral dose of vorinostat 200 mg in a fed state on Day 3.

Vorinostat 200 mg FED

Participants received a single oral dose of vorinostat 400 mg in a fed state on Day 3.

Vorinostat 400 mg FED

Participants received a single oral dose of vorinostat 500 mg in a fed state on Day 3.

Vorinostat 500 mg FED

All participants who complied with the protocol and had Day 3 PK data for AUC0-inf.

AUC0-Inf of Vorinostat After a Single Oral Dose in a Fed State

Participants received Vorinostat 100 mg twice daily, in the morning and evening, for 14 days (Days 5-18).

Vorinostat 100 mg Twice-daily

Participants received vorinostat 200 mg twice daily, in the morning and evening, for 14 days (Days 5-18).

Vorinostat 200 mg Twice-daily

Participants received vorinostat 400 mg once daily in the morning for 14 days (Days 5-18).

Vorinostat 400 mg Once-daily

Participants received vorinostat 500 mg once daily in the morning for 14 days (Days 5-18).

Vorinostat 500 mg Once-daily

All participants who complied with the protocol and had up to Day 19 PK data for AUC0-inf

AUC0-inf of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration

Participants received a single oral dose of vorinostat 100 mg in fasted state on Day 1

Participants received single oral dose of vorinostat 200 mg on Day 1 in a fasted state.

Participants received a single oral dose of vorinostat 400 mg on Day 1 in a fasted state.

Participants received a single oral dose of vorinostat 500 mg on Day 1 in a fasted state.

All participants who complied with the protocol and had Day 1 PK data for Cmax

Maximum Concentration (Cmax) of Vorinostat After a Single Oral Dose in a Fasted State

All participants who complied with the protocol and had Day 3 PK data for Cmax

Cmax of Vorinostat After a Single Oral Dose in a Fed State

All participants who complied with the protocol and had up to Day 19 PK data for Cmax

Cmax of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration

Participants received a single oral dose of vorinostat 100 mg in a fasted state on Day 1.

Participants received a single oral dose of vorinostat 200 mg in a fasted state on Day 1.

Participants received a single oral dose of vorinostat 400 mg in a fasted state on Day 1.

Participants received a single oral dose of vorinostat 500 mg in a fasted state on Day 1.

All participants who complied with the protocol and had Day 1 PK data for Tmax

Time to Maximum Concentration (Tmax) of Vorinostat After a Single Oral Dose in a Fasted State

All participants who complied with the protocol and had Day 3 PK data for Tmax

Tmax of Vorinostat After a Single Oral Dose in a Fed State

Participants received vorinostat 100 mg twice daily, in the morning and evening, for 14 days (Days 5-18).

Participants received vorinostat 400 mg once daily for 14 days (Days 5-18).

Participants received vorinostat 500 mg once daily for 14 days (Days 5-18).

All participants who complied with the protocol and had up to Day 19 PK data for Tmax

Tmax of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration

All participants who complied with the protocol and had Day 1 PK data for t½

Apparent Terminal Half-Life (t½) of Vorinostat After a Single Oral Dose in a Fasted State

All participants who complied with the protocol and had Day 3 PK data for t½

t½ of Vorinostat After a Single Oral Dose in a Fed State

All participants who complied with the protocol and had up to Day 19 PK data for t½

Spots Global Cancer Trial Database for A Study of Vorinostat in Patients With Solid Tumors (MK-0683-029)

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Study Description

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