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TerminatedNCT00126451Updated Apr 10, 2017

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 2 interventional study of MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) and 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 in Breast Cancer, Colorectal Cancer and Non-small-cell Lung Carcinoma, sponsored by Merck Sharp & Dohme LLC. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-10.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Dec 2004, registered Aug 2005).
Phase
Phase 2
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Breast Cancer
  • Colorectal Cancer
  • Non-small-cell Lung Carcinoma
03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's enrollment of 16 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

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Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.

Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.

Browse Merck Sharp & Dohme LLC studies →All Merck & Co., Inc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. 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.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Vansteenkiste J, Van Cutsem E, Dumez H, Chen C, Ricker JL, Randolph SS, Schoffski 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. PubMed 18425418 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00126451
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Aug 4, 2005
Start date
Dec 1, 2004
Primary completion
Oct 11, 2005
Completion
Oct 11, 2005
Last update
Apr 10, 2017

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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