Malignant Solid TumourPhase 1NCT00801151
Vorinostat in Combination With Vinorelbine in Patients With Advanced Cancer
A Phase 1 study testing Zolinza (vorinostat), vinorelbine in people with Malignant Solid Tumour, run by Institut Claudius Regaud at 3 sites in France.
Trial summary
This is a multi-center, open-label non-randomized dose-escalation trial of vorinostat given in combination with vinorelbine. Cohorts will be treated with a fixed dose of vinorelbine (25mg/m²/week continuously, representing the schedule that has been approved). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumour
- What is being tested?
- Zolinza (vorinostat), vinorelbine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2009to Nov 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Patients should have adequate bone marrow function without the current use of colony stimulating factors
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre René GAUDUCHEAU
Nantes Saint Herblain, 44805
Institut Curie
Paris, 75005
Institut Claudius REGAUD
Toulouse, 31052
About this study
Official title: A Phase I Clinical Trial of Vorinostat in Combination With Vinorelbine in Patients With Advanced Cancer.
This is a multi-center, open-label non-randomized dose-escalation trial of vorinostat given in combination with vinorelbine. Cohorts will be treated with a fixed dose of vinorelbine (25mg/m²/week continuously, representing the schedule that has been approved). Patients eligible will be enrolled into a standard 3+3 design with a starting dose of vorinostat at 200 mg po qd 7/21 (weekly schedule). Then, further dose levels will be explored. Toxicity of the schedule will be assessed during the first cycle. Patients may receive up to 6 cycles of study medication. Blood samples will be collected at specified time points to assess pharmacokinetic endpoints.
- Conditions
- Malignant Solid Tumour
- Being tested
- Zolinza (vorinostat), vinorelbine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zolinza (vorinostat), vinorelbineDrug
Also called Vorinostat, MK 0683, SAHA
Vorinostat will be administered orally at the starting dose of 200 mg po qd 7/21(weekly schedule) in combination with the standard dose of vinorelbine 25mg/m² per week as intravenous infusion over 10 minutes starting 4 hours after vorinostat administration.
Barring dose limiting toxicities the dose of vorinostat will escalate in several steps (300 mg po qd 7/21 days, 300 mg po qd 21/21 days, 400 mg po qd 7/21 days, 400 mg po qd 21/21 days).
Patients may receive a maximum of 6 cycles of study medication.
| Study group | Role | What they receive |
|---|---|---|
| Vorinostat, vinorelbine | Experimental | Vorinostat will be administered orally at the starting dose of 200 mg po qd 7/21(weekly schedule) in combination with the standard dose of vinorelbine 25mg/m² per week as intravenous infusion over 10 minutes starting 4 hours after vorinostat administration. Receives: Drug: Zolinza (vorinostat), vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) of vorinostat administered in combination with standard doses of vinorelbine.
Measured: at the end of the trial
Secondary outcomes (4)
To assess the pharmacokinetics of vorinostat and vinorelbine when administered in combination.
Measured: at the end of the trial
To assess the safety and tolerability of this regimen in advanced solid tumors.
Measured: at the end of the study
To make a preliminary assessment of the efficacy of the combination, in terms of response rate, response duration, time to response and time to progression.
Measured: At the end of the trial
To evaluate predictive pharmacodynamic biomarkers (e.g., histone acetylation in peripheral blood) when vorinostat is administered in combination with vinorelbine.
Measured: At the end of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Solid TumourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Jean-Pierre Delord, MD, PhD, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801151
- Sponsor's protocol ID
- 07 GENE 05
- Status last verified
- Sep 2026
- First submitted
- 2 Dec 2008
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Gandia P, Arellano C, Chalret du Rieu Q, Lochon I, Campone M, Pierga JY, Poublanc M, Hennebelle I, Filleron T, Chatelut E, Delord JP. Unexpected high levels of vorinostat when combined with vinorelbine in patients with advanced cancer. Curr Clin Pharmacol. 2011 Nov;6(4):274-9. doi: 10.2174/157488411798375921.
PubMed 22082325
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial of Vorinostat in Combination With Vinorelbine in Patients With Advanced Cancer.
- ClinicalTrials.gov ID
- NCT00801151
- Acronym / sponsor ID
- 07 GENE 05
- Conditions
- Malignant Solid Tumour
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 3 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, open-label non-randomized dose-escalation trial of vorinostat given in combination with vinorelbine. Cohorts will be treated with a fixed dose of vinorelbine (25mg/m²/week continuously, representing the schedule that has been approved). Patients eligible will be enrolled into a standard 3+3 design with a starting dose of vorinostat at 200 mg po qd 7/21 (weekly schedule). Then, further dose levels will be explored. Toxicity of the schedule will be assessed during the first cycle. Patients may receive up to 6 cycles of study medication. Blood samples will be collected at specified time points to assess pharmacokinetic endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vorinostat, vinorelbine | Experimental | Drug: Zolinza (vorinostat), vinorelbineVorinostat will be administered orally at the starting dose of 200 mg po qd 7/21(weekly schedule) in combination with the standard dose of vinorelbine 25mg/m² per week as intravenous infusion over 10 minutes starting 4 hours after vorinostat administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- For female patients of childbearing potential: must have a negative serum pregnancy test within 72 h before drug administration
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zolinza (vorinostat), vinorelbineAlso: Vorinostat, MK 0683, SAHAVorinostat will be administered orally at the starting dose of 200 mg po qd 7/21(weekly schedule) in combination with the standard dose of vinorelbine 25mg/m² per week as intravenous infusion over 10 minutes starting 4 hours after vorinostat administration. Barring dose limiting toxicities the dose of vorinostat will escalate in several steps (300 mg po qd 7/21 days, 300 mg po qd 21/21 days, 400 mg po qd 7/21 days, 400 mg po qd 21/21 days). Patients may receive a maximum of 6 cycles of study medication. | Drug | Vorinostat, vinorelbine |
Primary outcome
To determine the maximum tolerated dose (MTD) of vorinostat administered in combination with standard doses of vinorelbine.
Time frame: at the end of the trial
4 secondary outcomes
To assess the pharmacokinetics of vorinostat and vinorelbine when administered in combination.
Time frame: at the end of the trial
To assess the safety and tolerability of this regimen in advanced solid tumors.
Time frame: at the end of the study
To make a preliminary assessment of the efficacy of the combination, in terms of response rate, response duration, time to response and time to progression.
Time frame: At the end of the trial
To evaluate predictive pharmacodynamic biomarkers (e.g., histone acetylation in peripheral blood) when vorinostat is administered in combination with vinorelbine.
Time frame: At the end of the trial
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Results publication: PubMed 22082325Gandia P, Arellano C, Chalret du Rieu Q, Lochon I, Campone M, Pierga JY, Poublanc M, Hennebelle I, Filleron T, Chatelut E, Delord JP. Unexpected high levels of vorinostat when combined with vinorelbine in patients with advanced cancer. Curr Clin Pharmacol. 2011 Nov;6(4):274-9. doi: 10.2174/157488411798375921.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Pierre Delord, MD, PhD principal investigator
Institut Claudius Regaud
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zolinza (vorinostat), vinorelbine in people with Malignant Solid Tumour, run by Institut Claudius Regaud at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the maximum tolerated dose (MTD) of vorinostat administered in combination with standard doses of vinorelbine. (time frame: at the end of the trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00801151, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.