Solid TumorPhase 1NCT01317927
A Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies
A Phase 1 study testing Belinostat, Warfarin in people with Solid Tumor and Hematological Malignancy, run by Spectrum Pharmaceuticals, Inc at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the plasma concentration and pharmacodynamics effects of warfarin 5 mg, in the presence or absence of belinostat 1,000 mg/m². Pharmacokinetic evaluation of belinostat 1,000 mg/m² and metabolites in the presence of warfarin 5 mg. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Hematological Malignancy
- What is being tested?
- Belinostat, Warfarin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jun 2015
- 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
- Informed consent
- Histological or cytological confirmed diagnosis of malignant disease
- Age ≥18 years old
- Adequate organ function
- ECOG 0-2
- Estimated life expectancy >3months
- Negative pregnancy test for women of child bearing potential
Who cannot join
- Low dose anticoagulation therapy within 2 week prior to study treatment
- Anticancer therapy within 2 weeks prior to study treatment
- Investigational therapy within 4 weeks of study treatment
- Major surgery within 2 weeks of study treatment
- Coexisting active infection or other medical condition likely to interfere with trial procedures
- Significant cardiovascular disease (NYHA Class III or IV)
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- Baseline prolongation of QT/QTc
- Clinically significant CNS disorder, altered mental status or psychiatric disorders precluding understanding of the informed consent process and/or completing trial procedures
- Symptomatic or untreated CNS metastases
- Pregnant or breast feeding women
- Patients not willing to use effective contraception
- Known infection with HIV, Hep B or Hep C
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Center, University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: A Phase I Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies
The purpose of this study is to evaluate the plasma concentration and pharmacodynamics effects of warfarin 5 mg, in the presence or absence of belinostat 1,000 mg/m².
Pharmacokinetic evaluation of belinostat 1,000 mg/m² and metabolites in the presence of warfarin 5 mg.
Read the detailed description
This is an open-label, single center, pharmacokinetic and pharmacodynamic study in patients with solid tumor or hematological malignancies. Upon providing informed consent and satisfying screening procedures, eligible subjects will report to the clinic for Part I of the study 14 days before the first dose of belinostat (Day -14) for clinical laboratory tests, warfarin (5mg) single dose and a series PK collections. On days 1-5 of each 21-day cycle patients will receive belinostat 1000mg/m*2 and will have a series of subsequent PK samples collected. On day 3 of cycle 1 only, the patient will also receive warfarin 5mg single dose prior to belinostat infusion. PK samples, urine samples, electrocardiogram (ECG) and safety measurements will be collected from Day 1 through Day 10 of cycle one. If it is in the interest of the patient, belinostat can be continued during Part II- extension phase for 5 additional cycles of belinostat treatment on days 1-5 of each subsequent cycle, or until disease progression, patient withdraws consent or if unacceptable toxicity occurs. During the extension phase routine physical exams, laboratory tests and safety and efficacy assessments will be performed. Disease evaluations will be conducted per standard of care. Patients who discontinue for reasons other than disease progression will be followed until new anti-cancer treatment is initiated or death.
- Conditions
- Solid Tumor, Hematological Malignancy
- Being tested
- Belinostat, Warfarin
- Keywords
- belionstat, warfarin, hematological malignancy, solid tumors, PK/PD study
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belinostat, WarfarinDrug
Also called PXD101
1000 mg/m2 injection infusion given in a 30 min period plus Warfarin 5mg PO
| Study group | Role | What they receive |
|---|---|---|
| Warfarin, Belinostat | Experimental | Warfarin 5 mg po will be given on Day -14 and Day 3. Belinostat 1000 mg/m² will be given as a 30 minute IV infusion on Days 1 - 5 Receives: Drug: Belinostat, Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration and pharmacodynamic effects of warfarin
Samples will be analyzed for S-warfarin and R-warfarin analytes in all evaluable subjects at the end of the trial
Measured: 34 days
Pharmacokinetic evaluation of belinostat
Pharmacokinetic evaluation of belinostat 1,000 mg/m2 and metabolites in the presence of warfarin 5mg
Measured: 34 days
Secondary outcomes (3)
Presence of PK analytes for all subjects.
To measure the following analytes of all evaluable subjects at the end of the trial: Belinostat, belinostat glucuronide, methylated belinostat, Beliostat amide, belinostat acid and 3-ASBA.
Measured: 34 days
Safety profile of belinostat given concomitantly with warfarin
To evaluate the safety profile of belinostat given concomitantly with warfarin 5mg. Safety and tolerability assessment include adverse events (AEs), physical examination, vital signs, clinical laboratory tests, and electrocardiograms (ECGs).
Measured: 34 days
Overall survival of patients
To evaluate progress-free survival and to assess tumor measurement
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionJun 2015
- Study completionJun 2015
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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Valerio Therapeutics
- Responsible party
- Sponsor
- Investigators
- Sunil Sharma, MD, FACP, Principal investigator, Huntsman Cancer Institute, University of Utah, 2000 Circle of Hope, UT 84112
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317927
- Sponsor's protocol ID
- PXD101-CLN-20
- Status last verified
- Sep 2015
- First submitted
- 9 Mar 2011
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies
- ClinicalTrials.gov ID
- NCT01317927
- Acronym / sponsor ID
- PXD101-CLN-20
- Conditions
- Solid Tumor, Hematological Malignancy
- Keywords
- belionstat, warfarin, hematological malignancy, solid tumors, PK/PD study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- Valerio Therapeutics
- Study start
- Dec 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Mar 2011 (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.
The purpose of this study is to evaluate the plasma concentration and pharmacodynamics effects of warfarin 5 mg, in the presence or absence of belinostat 1,000 mg/m².
Pharmacokinetic evaluation of belinostat 1,000 mg/m² and metabolites in the presence of warfarin 5 mg.
Detailed description
This is an open-label, single center, pharmacokinetic and pharmacodynamic study in patients with solid tumor or hematological malignancies. Upon providing informed consent and satisfying screening procedures, eligible subjects will report to the clinic for Part I of the study 14 days before the first dose of belinostat (Day -14) for clinical laboratory tests, warfarin (5mg) single dose and a series PK collections. On days 1-5 of each 21-day cycle patients will receive belinostat 1000mg/m*2 and will have a series of subsequent PK samples collected. On day 3 of cycle 1 only, the patient will also receive warfarin 5mg single dose prior to belinostat infusion. PK samples, urine samples, electrocardiogram (ECG) and safety measurements will be collected from Day 1 through Day 10 of cycle one. If it is in the interest of the patient, belinostat can be continued during Part II- extension phase for 5 additional cycles of belinostat treatment on days 1-5 of each subsequent cycle, or until disease progression, patient withdraws consent or if unacceptable toxicity occurs. During the extension phase routine physical exams, laboratory tests and safety and efficacy assessments will be performed. Disease evaluations will be conducted per standard of care. Patients who discontinue for reasons other than disease progression will be followed until new anti-cancer treatment is initiated or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Warfarin, Belinostat | Experimental | Drug: Belinostat, WarfarinWarfarin 5 mg po will be given on Day -14 and Day 3. Belinostat 1000 mg/m² will be given as a 30 minute IV infusion on Days 1 - 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent
- Histological or cytological confirmed diagnosis of malignant disease
- Age ≥18 years old
- Adequate organ function
- ECOG 0-2
Key exclusion criteria (12 listed)
- Low dose anticoagulation therapy within 2 week prior to study treatment
- Anticancer therapy within 2 weeks prior to study treatment
- Investigational therapy within 4 weeks of study treatment
- Major surgery within 2 weeks of study treatment
- Coexisting active infection or other medical condition likely to interfere with trial procedures
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 |
|---|---|---|
| Belinostat, WarfarinAlso: PXD1011000 mg/m2 injection infusion given in a 30 min period plus Warfarin 5mg PO | Drug | Warfarin, Belinostat |
Primary outcome
Plasma concentration and pharmacodynamic effects of warfarin
Time frame: 34 days
Samples will be analyzed for S-warfarin and R-warfarin analytes in all evaluable subjects at the end of the trial
Pharmacokinetic evaluation of belinostat
Time frame: 34 days
Pharmacokinetic evaluation of belinostat 1,000 mg/m2 and metabolites in the presence of warfarin 5mg
3 secondary outcomes
Presence of PK analytes for all subjects.
Time frame: 34 days
Safety profile of belinostat given concomitantly with warfarin
Time frame: 34 days
Overall survival of patients
Time frame: 8 months
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 23 Sep 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.
Sunil Sharma, MD, FACP principal investigator
Huntsman Cancer Institute, University of Utah, 2000 Circle of Hope, UT 84112
1 site 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, Warfarin in people with Solid Tumor and Hematological Malignancy, run by Spectrum Pharmaceuticals, Inc at 1 site 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 7 inclusion and 12 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 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Plasma concentration and pharmacodynamic effects of warfarin (time frame: 34 days). 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 23 Sep 2015.