Clinical trial · Interventional

A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers (MK-0683-007)

A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers

NCT00907738CI-TRIAL-00017978completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This study will evaluate the safety and tolerability of continuing vorinostat (MK-0683) dosing in cancer patients previously enrolled in one of five base studies (MK-0683-001, MK-0683-006, MK-0683-008, MK-0683-012, or MK-0683-013) who have shown benefit from receiving this drug.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Advanced Cancer	Malignant Neoplasm	CURATED_BROADER	0.78

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
vorinostat	Drug	Vorinostat	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Vorinostat
interventionNames
1. Drug: vorinostat

Primary outcomes (1)

measure
Percent of Participants With a Serious Drug-related Adverse Event (AE)
timeFrame
From the first dose of study drug until the patient experiences disease progression, withdraws consent, or develops unacceptable toxicity (from Day 1 up to 4 years and 9 months)
description
A serious adverse event (SAE) was any AE occurring at any dose that resulted in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, or was an overdose. A drug-related SAE was one that was thought to be possibly, probably, or definitely related to the study drug.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Patient participated in one of the five vorinostat base protocols, has not shown tumor progression on that study, and has tolerated the study drug
* Patient did not withdraw from the base protocol
* Patient agrees to practice effective birth control during the study

Exclusion Criteria:

* Patient is receiving other standard and/or investigational anticancer therapy
* Patient has any condition or disease that would interfere with compliance or pose addition risk in administering the study drug

References

Publications (1)

RESULTDuvic M, Olsen EA, Breneman D, Pacheco TR, Parker S, Vonderheid EC, Abuav R, Ricker JL, Rizvi S, Chen C, Boileau K, Gunchenko A, Sanz-Rodriguez C, Geskin LJ. Evaluation of the long-term tolerability and clinical benefit of vorinostat in patients with advanced cutaneous T-cell lymphoma. Clin Lymphoma Myeloma. 2009 Dec;9(6):412-6. doi: 10.3816/CLM.2009.n.082. PMID 19951879