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)

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00126451
First received: August 2, 2005
Last updated: May 21, 2013
Last verified: May 2013

August 2, 2005
May 21, 2013
December 2004
October 2005   (final data collection date for primary outcome measure)
Response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to SAHA using RECIST criteria.
Not Provided
Complete list of historical versions of study NCT00126451 on ClinicalTrials.gov Archive Site
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.
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Not Provided
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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.

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Colorectal Cancer
  • Non-small-cell Lung Carcinoma
  • 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
Not Provided
Vansteenkiste J, Cutsem EV, 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 Apr 19; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
42
Not Provided
October 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00126451
2005_014, MK0683-011
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP