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)

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00126451
• Other study ID #: 0683-011
• Secondary ID: 2005_014
• Status: Terminated
• Phase: Phase 2
• First received: August 2, 2005
• Last updated: April 6, 2017
• Start date: December 1, 2004
• Est. completion date: October 11, 2005

Study information

• Verified date: April 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: October 11, 2005
• Est. primary completion date: October 11, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Vansteenkiste J, Van Cutsem E, Dumez H, Chen C, Ricker JL, Randolph SS, Schöffski P. Early phase II trial of oral vorinostat in relapsed or refractory breast, colorectal, or non-small cell lung cancer. Invest New Drugs. 2008 Oct;26(5):483-8. doi: 10.1007/s10637-008-9131-6. Epub 2008 Apr 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to SAHA using RECIST criteria.
Secondary	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.