Can a Two-Drug combo outsmart advanced cancer?
NCT ID NCT00801151
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are testing whether adding vorinostat to standard vinorelbine is safe and tolerable in adults with advanced solid tumors. The trial enrolls about 30 people and escalates the vorinostat dose in small groups to find the highest dose patients can take without severe side effects. Participants receive up to six cycles of the combination, and blood samples help track how the body processes both drugs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vorinostat given with vinorelbine
- What this could lead to
- If the combination proves safe, it could offer a new option for people with advanced solid tumors that have stopped responding to other treatments.
- What could go wrong
- This is an early phase 1 trial with about 30 participants, so the main goal is safety and dosing, not proving the combination works. Many phase 1 cancer drugs never move forward, and combining two drugs can raise the risk of side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Jan 2009
- Finished
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Nov 2009
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 values: * 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 ULN * 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 formula * 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 vorinostat) * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre René GAUDUCHEAU
Nantes Saint Herblain, 44805, France
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Institut Claudius REGAUD
Toulouse, 31052, France
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Institut Curie
Paris, 75005, France
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