Solid TumorPhase 1NCT00413075
Study of Oral PXD101 in Patients With Advanced Solid Tumors or Lymphoma
A Phase 1 study testing oral belinostat in people with Solid Tumor and Lymphoma, run by Valerio Therapeutics at 6 sites in 3 countries.
Trial summary
This is a Phase I dose escalation study of PXD101 administered orally. Oral belinostat will be given once or twice daily at various dosing schedules to patients with solid tumors. Doses will be escalated until the maximum tolerated dose (MTD) is identified. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Lymphoma
- What is being tested?
- oral belinostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Jun 2006to Aug 2011
- 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
None listed.
Who cannot join
- Patients who meet any of the following criteria are not eligible to enroll in this trial:
- Prior treatment with PXD101
- Solid Tumor: Anticancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the last 4 weeks or a longer period depending on the defined characteristics of the agents used (e.g. 6 weeks for mitomycin or nitrosourea) Lymphoma: No anticancer therapy within 2 weeks except for Rituximab which patients should be off for greater than three months unless there is evidence of disease progression.
- Lymphoma patients who have relapsed within 100 days of autologous or allogeneic transplantation.
- Serious concomitant systemic disorders (eg, active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
- Presence of metastatic disease that, in the opinion of the investigator, would require palliative treatment within 4 weeks of enrollment
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- Symptomatic brain metastases
- Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure (NYHA Class III or IV) related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry
- A marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval >500 msec; Long QT Syndrome; the required use of concomitant medication on PXD101 dosing days that may cause Torsade de Pointes (See Section 11.7)
- Altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
- Pregnant or breast-feeding women
- Men and women of childbearing age and potential, who are not willing to use effective contraception
- Major surgery within the last 4 weeks
- Known HIV positivity, as safety in this patient population has not been assessed.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
M.D. Anderson Cancer Center
Houston, Texas, 77230-1402
Yale New Haven Hospital
New Haven, Connecticut, 06520
Columbia University - Herbert Irving Cancer Center
New York, New York, 01132
New York University Cancer Institute
New York, New York, 10016
About this study
Official title: Open Label, Dose Escalation Trial of Oral PXD101 in Patients With Advanced Solid Tumors
This is a Phase I dose escalation study of PXD101 administered orally. Oral belinostat will be given once or twice daily at various dosing schedules to patients with solid tumors. Doses will be escalated until the maximum tolerated dose (MTD) is identified. In parallel, a cohort of lymphoma patients will be given oral belinostat on a discontinuous once daily dosing schedule.
- Conditions
- Solid Tumor, Lymphoma
- Being tested
- oral belinostat
- Keywords
- Solid tumors, Adenosarcoma, B-cell lymphoma, belinostat, bladder cancer, Breast cancer, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Chondrosarcoma, colorectal cancer, Esophageal Neoplasms, Fibrosarcoma, head and neck cancer, Hemangiosarcoma, Hodgkins Disease, kidney cancer, Leiomyosarcoma, Liposarcoma, lung cancer, lymphoma
- Medical subject headings
- Lymphoma, Adenosarcoma, Lymphoma, B-Cell, Urinary Bladder Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Chondrosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral belinostatDrug
Also called PXD101
oral belinostat dosed once or twice daily at continuous and discontinuous dosing schedules.
| Study group | Role | What they receive |
|---|---|---|
| oral belinostat | Experimental | Not described Receives: Drug: oral belinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, tolerability and maximum tolerated dose of orally administered PXD101 for each cohort
Measured: throughout the study
Secondary outcomes (3)
Determine the pharmacokinetics of oral PXD101 when dosed once or twice daily at various dose levels
Measured: throughout the study
Explore anti-tumor activity
Measured: throughout the study
Determine the safety, tolerability, and anti-tumor activity of orally administered PXD101 to patients with lymphoma
Measured: throughout the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2006 (estimated)
- Study startJun 2006
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valerio Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Spectrum Pharmaceuticals, Inc
- Responsible party
- Sponsor
- Investigators
- enquiries@topotarget.com, Study chair, Valerio Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413075
- Sponsor's protocol ID
- PXD101-CLN-9
- Status last verified
- Jul 2015
- First submitted
- 18 Dec 2006
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Dose Escalation Trial of Oral PXD101 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00413075
- Acronym / sponsor ID
- PXD101-CLN-9
- Conditions
- Solid Tumor, Lymphoma
- Keywords
- Solid tumors, Adenosarcoma, B-cell lymphoma, belinostat, bladder cancer, Breast cancer, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Valerio TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Spectrum Pharmaceuticals, Inc
- Study start
- Jun 2006
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 19 Dec 2006 (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 Phase I dose escalation study of PXD101 administered orally. Oral belinostat will be given once or twice daily at various dosing schedules to patients with solid tumors. Doses will be escalated until the maximum tolerated dose (MTD) is identified. In parallel, a cohort of lymphoma patients will be given oral belinostat on a discontinuous once daily dosing schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oral belinostat | Experimental | Drug: oral belinostat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- Prior treatment with PXD101
- Solid Tumor: Anticancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the last 4 weeks or a longer period depending on the defined characteristics of the agents used (e.g. 6 weeks for mitomycin or nitrosourea) Lymphoma: No anticancer therapy within 2 weeks except for Rituximab which patients should be off for greater than three months unless there is evidence of disease progression.
- Lymphoma patients who have relapsed within 100 days of autologous or allogeneic transplantation.
- Serious concomitant systemic disorders (eg, active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
- Presence of metastatic disease that, in the opinion of the investigator, would require palliative treatment within 4 weeks of enrollment
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 |
|---|---|---|
| oral belinostatAlso: PXD101oral belinostat dosed once or twice daily at continuous and discontinuous dosing schedules. | Drug | oral belinostat |
Primary outcome
Safety, tolerability and maximum tolerated dose of orally administered PXD101 for each cohort
Time frame: throughout the study
3 secondary outcomes
Determine the pharmacokinetics of oral PXD101 when dosed once or twice daily at various dose levels
Time frame: throughout the study
Explore anti-tumor activity
Time frame: throughout the study
Determine the safety, tolerability, and anti-tumor activity of orally administered PXD101 to patients with lymphoma
Time frame: throughout the trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
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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.
enquiries@topotarget.com study chair
Valerio Therapeutics
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing oral belinostat in people with Solid Tumor and Lymphoma, run by Valerio Therapeutics at 6 sites in 3 countries.
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 0 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: finished, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Denmark, United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety, tolerability and maximum tolerated dose of orally administered PXD101 for each cohort (time frame: throughout the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2015; AzTrials last refreshed its copy on 7 Nov 2026.