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Completed

NCT Number: NCT00127127

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

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.

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Key information

Conditions

Tumors Neoplasms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with histologically or cytologically diagnosed solid tumor; no standard therapy available or participant has failed to respond to standard therapy

Exclusion criteria

  • Participants with history of immunotherapy, radiotherapy, surgery, or chemotherapy during the previous 4 weeks; previous treatment is 5 or more chemotherapeutic regimens.
  • Any uncontrolled concomitant illness
  • Are pregnant or breast-feeding
  • Serious drug or food allergy

Treatment and study plan

Vorinostat

Drug

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

Other names: MK-0683, L-001079038, suberoylanilide hydroxamic acid (SAHA)

Primary outcomes

  1. Number of Participants Who Experienced One or More Adverse Events

    Time frame: Up to approximately 4 years

    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.

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

    Time frame: Up to approximately 4 years

    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.

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

    Time frame: Up to 26 days

    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.

Secondary outcomes

  1. 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

    Time frame: Day 1: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

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

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

    Time frame: Day 3: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

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

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

    Time frame: Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

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

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

    Time frame: Day 1: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

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

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

    Time frame: Day 3: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

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

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

    Time frame: Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

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

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

    Time frame: Day 1: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

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

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

    Time frame: Day 3: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

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

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

    Time frame: Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

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

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

    Time frame: Day 1: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-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.

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

    Time frame: Day 3: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-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.

  12. t½ of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration

    Time frame: Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Aug 5, 2005
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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