TumorPhase 1NCT00413322
Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors
A Phase 1 study testing belinostat and 5-Fluorouracil (5-FU) in people with Tumor, run by Valerio Therapeutics at 3 sites in United States.
Trial summary
This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor activity, and how the study drug behaves within the body when given with 5-Fluorouracil (5-FU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor
- What is being tested?
- belinostat and 5-Fluorouracil (5-FU)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2005to Jun 2008
- 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
- Histologically confirmed solid tumors
- Advanced colorectal cancer or other adenocarcinomas
- Tumor progression after standard chemotherapy, or where none yet approved
- At least one unidimensionally measurable lesion
- Karnofsky performance >= 70%
- Life expectancy of at least 3 months
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- Age >= 18 years
- Signed, written Institutional Review Board (IRB)-approved informed consent
- Acceptable liver function:
- Bilirubin <= 1.5 x upper limit of normal (ULN)
- AST (SGOT) and ALT (SGPT) <= 2.5 x ULN, OR
- AST (SGOT) and ALT (SGPT) <= 5 x ULN if liver metastasis
- Acceptable renal function:
- Serum creatinine within normal limits, OR
- Calculated creatinine clearance of >= 60 mL/min/1.73 m2 for certain patients
- Acceptable hematologic status:
- Absolute neutrophil count (ANC) >= 1500 cells/mm3
- Platelet count >= 100,000 (plt/mm3)
- Hemoglobin >= 9 g/dL
- Urinalysis: No clinically significant abnormalities
- Acceptable coagulation status:
- Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits, OR
- For patients on anticoagulation therapy, status within therapeutic range
- For men and women of child-producing potential, use of effective contraception
- Tumors accessible for needle biopsy
Who cannot join
- Significant cardiovascular disease.
- A marked baseline prolongation of QT/QTc interval
- Long QT syndrome
- Required use of medication on dosing days that may cause torsade de pointes.
- Infections requiring intravenous (IV) systemic therapy
- Pregnant or nursing women
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- Treatment with chemotherapy or investigational therapy < 4 weeks (28 days) prior to study entry (6 weeks for nitrosoureas, mitomycin C, or Avastin).
- Treatment with radiation therapy or surgery either within 2 weeks prior to study entry, or not yet recovered if 2-4 weeks prior to study entry.
- Unwillingness or inability to comply with protocol procedures.
- Known active uncontrolled infection with HIV, hepatitis B, or hepatitis C
- Serious nonmalignant disease (e.g. hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
- Concurrent use of other investigational agent(s)
- Serious concurrent medical illness
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Nebraska
Omaha, Nebraska, 68198-7680
Portsmouth Regional Hospital Hematology/Oncology Clinic
Portsmouth, New Hampshire, 03801
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
About this study
Official title: A Phase I Safety, Pharmacodynamic, Anti-Tumor Activity, and Pharmacokinetic Study of PXD101 Alone and in Combination With 5-Fluorouracil in Patients With Advanced Solid Tumors
This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor activity, and how the study drug behaves within the body when given with 5-Fluorouracil (5-FU).
- Conditions
- Tumor
- Being tested
- belinostat, 5-Fluorouracil (5-FU)
- Keywords
- Advanced Solid tumor, Adenosarcoma, Androgen-independent prostate cancer, belinostat, bladder cancer, bladder neoplasms, Breast cancer, Carcinoma, Bronchogenic, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Carcinosarcoma, Chondrosarcoma, Coin Lesion, Pulmonary, colorectal cancer, Esophageal Neoplasms, Facial Neoplasms, Fibrosarcoma, head and neck cancer, Hemangiosarcoma, Histiocytoma, Malignant Fibrous
- Medical subject headings
- Neoplasms, Adenosarcoma, Urinary Bladder Neoplasms, Breast Neoplasms, Carcinoma, Bronchogenic, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Carcinosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
belinostatDrug
Also called PXD101
300, 600, or 1000 mg/m2 belinostat IV for 5 days every 21 days starting with cycle 1
5-Fluorouracil (5-FU)Drug
Also called 5-FU
250, 500, 750, or 1000 mg/m2/d of 5-FU starting with cycle 2 onwards in combination with belinostat. Starting on day 2, 5-FU is administered as a continuous 96 hour infusion.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm dose escalation | Experimental | Not described Receives: Drug: belinostat; Drug: 5-Fluorouracil (5-FU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the maximum tolerated dose of PXD101 administered in combination with 5-FU
Measured: throughout the study
to determine whether PXD101 alone can down-regulate thymidylate synthase in patient tumors
Measured: throughout the study
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 startSep 2005
- Primary completionMar 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valerio Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Topotarget A/S, Study chair, Valerio Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413322
- Sponsor's protocol ID
- PXD101-CLN-4
- 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
- A Phase I Safety, Pharmacodynamic, Anti-Tumor Activity, and Pharmacokinetic Study of PXD101 Alone and in Combination With 5-Fluorouracil in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00413322
- Acronym / sponsor ID
- PXD101-CLN-4
- Conditions
- Tumor
- Keywords
- Advanced Solid tumor, Adenosarcoma, Androgen-independent prostate cancer, belinostat, bladder cancer, bladder neoplasms, Breast cancer, Carcinoma, Bronchogenic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Valerio TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jun 2008 (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 study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor activity, and how the study drug behaves within the body when given with 5-Fluorouracil (5-FU).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm dose escalation | Experimental | Drug: belinostat, Drug: 5-Fluorouracil (5-FU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Histologically confirmed solid tumors
- Advanced colorectal cancer or other adenocarcinomas
- Tumor progression after standard chemotherapy, or where none yet approved
- At least one unidimensionally measurable lesion
- Karnofsky performance >= 70%
Key exclusion criteria (13 listed)
- Significant cardiovascular disease.
- A marked baseline prolongation of QT/QTc interval
- Long QT syndrome
- Required use of medication on dosing days that may cause torsade de pointes.
- Infections requiring intravenous (IV) systemic therapy
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 |
|---|---|---|
| belinostatAlso: PXD101300, 600, or 1000 mg/m2 belinostat IV for 5 days every 21 days starting with cycle 1 | Drug | Single-arm dose escalation |
| 5-Fluorouracil (5-FU)Also: 5-FU250, 500, 750, or 1000 mg/m2/d of 5-FU starting with cycle 2 onwards in combination with belinostat. Starting on day 2, 5-FU is administered as a continuous 96 hour infusion. | Drug | Single-arm dose escalation |
Primary outcome
to determine the maximum tolerated dose of PXD101 administered in combination with 5-FU
Time frame: throughout the study
to determine whether PXD101 alone can down-regulate thymidylate synthase in patient tumors
Time frame: throughout the study
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.
Topotarget A/S study chair
Valerio Therapeutics
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 belinostat and 5-Fluorouracil (5-FU) in people with Tumor, run by Valerio Therapeutics at 3 sites in United States.
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 25 inclusion and 13 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 3 sites in United States. 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?
to determine the maximum tolerated dose of PXD101 administered in combination with 5-FU (time frame: throughout the study). The study lists 2 primary outcomes in all. 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.