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Completed

NCT Number: NCT00373490

A Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Patients With Solid Tumors (0683-048)

This is a clinical study to evaluate the safety and pharmacokinetics of an overseas determined maximum tolerated dose (MTD) of MK-0683 (vorinostat) in a Japanese patient population with solid tumors.

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Key information

Conditions

Tumors Neoplasms

Age range

20 year and older

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

  • Patients with histologically or cytologically diagnosed solid tumor in whom no standard therapy is available or the malignancy is refractory to standard therapy

Exclusion criteria

  • Patients with history of immunotherapy, radiotherapy, surgery, or chemotherapy during the previous 4 weeks
  • Any uncontrolled concomitant illness
  • Pregnant or breast-feeding
  • Serious drug or food allergy

Treatment and study plan

Vorinostat

Drug

600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest.

Other names: MK-0683, Suberoylanilide Hydroxamic Acid (SAHA)

Primary outcomes

  1. Number of Participants With a Dose Limiting Toxicity (DLT)

    Time frame: 21 Days (first cycle)

    Dose Limiting Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment

Secondary outcomes

  1. Area Under the Curve (AUC(0-infinity)) at Day 1 (600 mg and 400 mg)

    Time frame: Day 1 (600 mg and 400 mg)

    Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (o- ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). At 600 mg, t=12 hours and at 400 mg, t=24 hours.

  2. Area Under the Curve (AUC(0-infinity)) at Day 3 (600 mg)

    Time frame: Day 3 (600 mg)

    Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 ｈours. It is obtained from AUC (0 - 12) plus AUC (12 - ∞)

  3. Area Under the Curve (AUC(0-infinity) at Day 21 (400 mg)

    Time frame: Day 21 (400 mg)

    Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 ｈours. It is obtained from AUC (0 - 24) plus AUC (24 - ∞)

  4. Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg)

    Time frame: Day 1 (600 mg and 400 mg)

  5. Maximum Concentration (Cmax) at Day 3 (600 mg)

    Time frame: Day 3 (600 mg)

  6. Maximum Concentration (Cmax) at Day 21 (400 mg)

    Time frame: Day 21 (400 mg)

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

MK0683 Phase1 Clinical Study - Solid Tumor -

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 8, 2006
Registry last updated
Aug 27, 2015

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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