Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Colorectal Cancer, Non-small-cell Lung Carcinoma

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

2005_014

NCT ID:

NCT00126451

Start Date:

December 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • Colorectal Cancer
  • Non-Small-Cell Lung Carcinoma
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Neoplasms
  • Lung Neoplasms

Name

Location