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

Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00127127
• Other study ID #: 0683-029
• Secondary ID: 2005_040MK-0683-
• Status: Completed
• Phase: Phase 1
• Start date: June 10, 2005
• Est. completion date: August 21, 2009

Study information

• Verified date: August 2022
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 21, 2009
• Est. primary completion date: August 21, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Tumors

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

References & Publications (1)

Fujiwara Y, Yamamoto N, Yamada Y, Yamada K, Otsuki T, Kanazu S, Iwasa T, Hardwick JS, Tamura T. Phase I and pharmacokinetic study of vorinostat (suberoylanilide hydroxamic acid) in Japanese patients with solid tumors. Cancer Sci. 2009 Sep;100(9):1728-34. doi: 10.1111/j.1349-7006.2009.01237.x. Epub 2009 May 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced One or More Adverse Events	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.	Up to approximately 4 years
Primary	Number of Participants Who Discontinued Study Treatment Due to an Adverse Event	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.	Up to approximately 4 years
Primary	Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1	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.	Up to 26 days
Secondary	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	AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.	Day 1: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
Secondary	AUC0-Inf of Vorinostat After a Single Oral Dose in a Fed State	AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.	Day 3: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
Secondary	AUC0-inf of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration	AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.	Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
Secondary	Maximum Concentration (Cmax) of Vorinostat After a Single Oral Dose in a Fasted State	Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.	Day 1: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
Secondary	Cmax of Vorinostat After a Single Oral Dose in a Fed State	Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.	Day 3: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
Secondary	Cmax of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration	Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.	Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
Secondary	Time to Maximum Concentration (Tmax) of Vorinostat After a Single Oral Dose in a Fasted State	Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.	Day 1: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
Secondary	Tmax of Vorinostat After a Single Oral Dose in a Fed State	Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.	Day 3: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
Secondary	Tmax of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration	Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.	Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
Secondary	Apparent Terminal Half-Life (t½) of Vorinostat After a Single Oral Dose in a Fasted State	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.	Day 1: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
Secondary	t½ of Vorinostat After a Single Oral Dose in a Fed State	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.	Day 3: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
Secondary	t½ of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration	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.	Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose