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Continuation Clinical Trial of Oral L-0010790038 in Advanced Cancer


N/A
N/A
N/A
Not Enrolling
Both
Advanced Cancer

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Trial Information

Continuation Clinical Trial of Oral L-0010790038 in Advanced Cancer


It is standard practice in the development of drugs treating advanced cancer where standard
alternative therapy does not exist to continue to offer drug beyond the confines of the
parent protocol to patients who are plausibly receiving benefit from it (e.g., those
patients who are tolerant of and not progressing on the therapy of the base protocol). Such
practice avoids the situation of a responding or potentially responding patient being denied
drug after a study of limited duration.

Therefore, this protocol is designed to provide a mechanism for non-progressing patients on
L-001079038 protocols to receive drug until disease progression or unacceptable toxicity
occurs. There is no significant data capture with regard to safety or efficacy of
L-001079038 over the longer treatment period; only SAEs will be captured and reported.


Inclusion Criteria:



- Patient has completed participation in one of the Suberoylanilide Hydroxamic Acid
(SAHA) protocols, has not shown tumor progression while on study treatment, and has
tolerated the study drug without unacceptable toxicities.

- Patient has not met criteria for withdrawal from the base protocol.

- Patient is willing to comply with protocol requirements and procedures, and keep
scheduled study visits.

- Patient agrees to practice effective contraception during the entire study period
unless documentation of infertility exists.

- Patient is able to understand and is willing to sign the informed consent form.

Exclusion Criteria:

- Patient is receiving concomitant standard and/or investigational anticancer therapy.
Local palliative radiotherapy is permissible upon discussion with the Merck Clinical
Monitor.

- Patient has alcohol or substance abuse which in the opinion of the investigator would
interfere with compliance or safety.

- Patient has any condition or laboratory abnormality which, in the opinion of the
investigator, would pose additional risk in administering the study drug to the
patient.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the long-term safety and tolerability of L-001079038 administered orally in patients with advanced cancers.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Lee Krug, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

05-072

NCT ID:

NCT00588055

Start Date:

August 2005

Completion Date:

July 2008

Related Keywords:

  • Advanced Cancer
  • Cancer
  • Advanced Cancer
  • L-001079038
  • SAHA
  • Vorinostat
  • Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021