A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed or Refractory Breast, Colorectal and Non-Small Cell Lung Cancer (0683-011)(TERMINATED)

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 2

Conditions

Breast Cancer

Non-small-cell Lung Carcinoma

Colorectal Cancer

Treatments

Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA)

Drug: Duration of Treatment - During each treatment cycle, treatment is administered twice daily for 14 days, followed by 7 days of rest for a total of 10 cycles

Study type

Interventional

Funder types

Industry

Identifiers

NCT00126451

2005_014

0683-011

Details and patient eligibility

About

This is an investigational study to determine the response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to oral suberoylanilide hydroxamic acid (SAHA), to evaluate PET as an earlier indicator of response to SAHA as assessed by response evaluation criteria in solid tumours (RECIST) criteria and to evaluate the safety and tolerability of oral suberoylanilide hydroxamic acid.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient must be 18 years or older with confirmed diagnosis of breast adenocarcinoma, colorectal carcinoma or non-small cell lung cancer
Patients must have relapsed or refractory disease following at least one chemotherapeutic treatment regimen.
Has a measurable, positron emission tomography (PET) assessable lesion
Adequate blood, liver, bone marrow and kidney functions
Has not received any chemotherapy for at least 4 weeks prior to entry in this study
Agrees to take adequate measures to prevent pregnancy.

Exclusion criteria

Patient has had prior treatment with histone deacetylase (HDAC) inhibitor.
Patient has had treatment with investigational agents within the last 30 days.
Patient has active infection or had intravenous (IV) antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drugs.
Patient has HIV, hepatitis B or hepatitis C infection.
Patient is pregnant or lactating.
Patient has allergy to any component of the study drug.