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)

A Phase II Clinical Study of Oral Suberoylanilide Hydroxamic Acid in Patients With Relapsed or Refractory Breast, Colorectal, and Non-small Cell Lung Cancer.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00126451

Enrollment

Registered

2005-08-04

Start date

2004-12-01

Completion date

2005-10-11

Last updated

2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Colorectal Cancer, Non-small-cell Lung Carcinoma

Brief summary

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.

Interventions

DRUGMK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA)

DRUGDuration 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 design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to SAHA using RECIST criteria.	—

Secondary

Measure	Time frame
Positron emission tomography (PET) as an earlier indicator of the response to SAHA as assessed by RECIST criteria. To evaluate the safety and tolerability of SAHA for 14 days every 21 days.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026