Antineoplastic Agents

All Drugs and Chemicals

Vorinostat

Histone Deacetylase Inhibitors

Enzyme Inhibitors

All patients will receive vorinostat at the same dose and schedule as they received in the base protocol until disease progression or unacceptable toxicity.

vorinostat

Medical Monitor

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.

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

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.

Merck Sharp & Dohme LLC

The MedDRA version used for protocol 001 was 13.0 For all the other protocols (006, 008,012, and 013), the MedDRA version used was 11.1.

Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.

Base Protocol 001 (Vorinostat 400 mg Once Daily [QD])

Base Protocol 006 (Vorinostat 200 mg Twice Daily [BID])

Base Protocol 008 (Vorinostat 400 mg Once Daily [QD])

Base Protocol 012 (Vorinostat 400 mg Once Daily [QD] 7/21)

Base Protocol 012 (Vorinostat 300 mg Twice Daily [BID] 3/7)

Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 14/21)

Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 7/21)

Base Protocol 013 (Vorinostat 200 mg Twice Daily [BID] 14/21)

Base Protocol 013 (Vorinostat 300 mg Twice Daily [BID] 3/7)

Base Protocol 001

Base Protocol 006

Base Protocol 008

400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel \& cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel

Base Protocol 012

vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)

Base Protocol 013

Total

All participants were at least 18 years of age.

Age, Customized

Sex: Female, Male

Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.

Spots Global Cancer Trial Database for A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers (MK-0683-007)

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