Clinical trial NCT00127127: A Study of Vorinostat in Patients With Solid Tumors (MK-0683-029)
Official title: A Phase I Clinical Study of L-001079038 in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumors
Keywords: Solid tumors
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-08-05
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Experienced One or More Adverse Events
timeFrame: Up to approximately 4 years
measure: Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
timeFrame: Up to approximately 4 years
measure: Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1
timeFrame: Up to 26 days
Secondary outcomes:
measure: 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
timeFrame: Day 1: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
measure: AUC0-Inf of Vorinostat After a Single Oral Dose in a Fed State
timeFrame: Day 3: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
measure: AUC0-inf of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration
timeFrame: Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
measure: Maximum Concentration (Cmax) of Vorinostat After a Single Oral Dose in a Fasted State
timeFrame: Day 1: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
measure: Cmax of Vorinostat After a Single Oral Dose in a Fed State
timeFrame: Day 3: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
measure: Cmax of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration
timeFrame: Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
measure: Time to Maximum Concentration (Tmax) of Vorinostat After a Single Oral Dose in a Fasted State
timeFrame: Day 1: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
measure: Tmax of Vorinostat After a Single Oral Dose in a Fed State
timeFrame: Day 3: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
measure: Tmax of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration
timeFrame: Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
measure: Apparent Terminal Half-Life (t½) of Vorinostat After a Single Oral Dose in a Fasted State
timeFrame: Day 1: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
measure: t½ of Vorinostat After a Single Oral Dose in a Fed State
timeFrame: Day 3: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
measure: t½ of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration
timeFrame: Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.