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A Phase I Clinical Trial of Vorinostat in Combination With Vinorelbine in Patients With Advanced Cancer.

Phase 1
18 Years
Not Enrolling
Malignant Solid Tumour

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Trial Information

A Phase I Clinical Trial of Vorinostat in Combination With Vinorelbine in Patients With Advanced Cancer.

Inclusion Criteria:

- Patient must have a histologically-confirmed metastatic or locally advanced cancer.

- Patient is ≥ 18 years of age on day of signing informed consent.

- Patient must have performance status < 1 on the ECOG performance scale.

- Patient must have adequate organ function as indicated by the following laboratory

- Hematological: absolute neutrophil count (ANC) ≥ 1,5x109/L; platelets ≥ 100
x109/L; hemoglobin ≥ 9 g/dL

- Renal : calculated creatinine clearance b ≥ 60 mL/min

- Hepatic : serum total bilirubin ≤ 1.5 X ULN ; AST (SGOT) and ALT (SGPT) ≤ 2.5 X
ULN; alkaline phosphatase if > 2.5 X ULN, then liver fraction should be ≤ 2.5 X

- Coagulation : prothrombin time (PT) ≤1.2 X ULN ; partial thromboplastin time
(PTT) ≤1.2 X ULN

1. Patients should have adequate bone marrow function without the current use
of colony stimulating factors

2. Creatinine clearance should be calculated according to Cockcroft-Gault

- For female patients of childbearing potential: must have a negative serum pregnancy
test within 72 h before drug administration

- Male and Female patients of childbearing potential must agree to use an adequate
method of contraception throughout the study starting with Visit 1 and for at least
30 days after the last dose of study medication.

- Patient has voluntarily agreed to participate by giving written informed consent.

- Patient must be available for periodic blood sampling, study related assessments, and
management at the treating institution of the duration of the study.

Exclusion Criteria:

- Patient is currently participating or has participated in a study with an
investigational compound or device within 30 days of signing informed consent.

- Patient pre-treated with one of the two investigational compounds (ie; vinorelbine or

- Patients with active CNS metastases and/or carcinomatous meningitis and uncontrolled
brain metastases are excluded. However, patients with CNS metastases who have
completed a course of therapy would be eligible for the study provided they are
clinically stable for 3 months prior to entry as defined as: (1) no evidence of new
or enlarging CNS metastasis (2) off steroids or on a stable dose of steroids.

- Patient has known hypersensitivity to the components of study drug or its analogs.

- Patient has a history or current evidence of any condition, therapy, or lab
abnormality that might confound the results of the study, interfere with the
patient's participation for the full duration of the study, or is not in the best
interest of the patient to participate

- Patient has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.

- Patient is, at the time of signing informed consent, a regular user (including
"recreational use") of any illicit drugs or had a recent history (within the last
year) of drug or alcohol abuse.

- Patient is pregnant or nursing,

- Patient is known to be Human Immunodeficiency Virus (HIV)-positive.

- Patient has known history of Hepatitis B or C.

- Patient with a history of a prior malignancy with the exception of cervical
intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated
localized prostate carcinoma with PSA <1.0; or who has undergone potentially curative
therapy with no evidence of that disease for five years, and who is deemed at low
risk for recurrence by his/her treating physician

- Patient has preexisting grade 2 or higher neuropathy

- Patients who had received radiotherapy to more than 30% of the bone marrow surface
(i.e whole pelvis)

- Patients under law protection

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose (MTD) of vorinostat administered in combination with standard doses of vinorelbine.

Outcome Time Frame:

at the end of the trial

Safety Issue:


Principal Investigator

Jean-Pierre Delord, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Claudius Regaud


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

07 GENE 05



Start Date:

January 2009

Completion Date:

November 2009

Related Keywords:

  • Malignant Solid Tumour
  • Neoplasms