- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00413075
Study of Oral PXD101 in Patients With Advanced Solid Tumors or Lymphoma
July 7, 2015 updated by: Onxeo
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
121
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark
- Research Facility
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Surrey
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London, Surrey, United Kingdom, SW3 6JJ
- Research Facility
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale New Haven Hospital
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New York
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New York, New York, United States, 10016
- New York University Cancer Institute
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New York, New York, United States, 01132
- Columbia University - Herbert Irving Cancer Center
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Texas
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Houston, Texas, United States, 77230-1402
- M.D. Anderson Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria Inclusion criteria must be met at the time of screening unless otherwise specified.
- Age ≥ 18 years
- Solid Tumor: Histologically documented diagnosis of primary or metastatic solid tumors refractory to standard therapy or for which no standard therapy exists. Entry will include, but is not limited to patients with androgen-independent prostate cancer, and cancers of the breast, ovary, head and neck, non-small cell lung, bladder, colorectal or kidney. Lymphoma: Relapsed or refractory B-Cell, T-Cell or NK-Cell lymphoma or Hodgkin's Disease. At Yale Cancer Center, lymphoma patients will be limited to those who are not eligible for potentially curative re-induction regimens and transplant and without a reasonable chance of having durable remissions with standard therapies.
- At least one evaluable lesion. Lesions must be evaluated by CT-scan, MRI, or bone scan. Patients with prostate cancer, bone disease and rising PSA but no other evaluable disease are eligible and will be evaluated based on PSA. For lymphoma patients, lesions can also be measured by PET and/or evaluated in peripheral blood or bone marrow.
- Progressive disease: Progressive disease will be defined as new or progressive lesions on CT-scan, MRI, bone scan or by rising PSA (see Section 11.3).
- ≥ 4 weeks since prior RT or chemotherapy.
- Karnofsky Performance Status ≥ 60%
Solid Tumor: Acceptable liver, renal and bone marrow function including the following:
- Absolute neutrophil count ≥ 1.5 x 109/L
- Hemoglobin ≥ 9.0 g/dl
- Platelets ≥ 100 x 109/L
- Bilirubin ≤ 1.5 times the upper limit of normal (x ULN)
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN (≤ 5.0 x ULN is acceptable if liver has tumor involvement)
- Serum Creatinine ≤ 1.5 x ULN
- PT-INR/PTT ≤ 1.5 x ULN or in the therapeutic range if on anticoagulation therapy
Lymphoma: Acceptable liver, renal and bone marrow function including the following:
- Absolute Neutrophil Count ≥ 1.0 x 109/L
- Platelets ≥ 50 x 109/L
- Bilirubin ≤ 1.5 times the upper limit of normal (x ULN), or ≤ 3 times ULN if documented hepatic involvement with lymphoma, or ≤ 5 times ULN if history of Gilbert's disease
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN (≤ 5.0 x ULN is acceptable if liver has tumor involvement)
- Serum Creatinine ≤ 1.5 x ULN
- PT-INR/PTT ≤ 1.5 x ULN or in the therapeutic range if on anticoagulation therapy
- Serum potassium within normal range
- Estimated life expectancy greater than 3 months
- Signed informed consent must be obtained prior to any study specific procedures
Exclusion Criteria
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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: oral belinostat
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oral belinostat dosed once or twice daily at continuous and discontinuous dosing schedules.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Safety, tolerability and maximum tolerated dose of orally administered PXD101 for each cohort
Time Frame: throughout the study
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throughout the study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Determine the pharmacokinetics of oral PXD101 when dosed once or twice daily at various dose levels
Time Frame: throughout the study
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throughout the study
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Explore anti-tumor activity
Time Frame: throughout the study
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throughout the study
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Determine the safety, tolerability, and anti-tumor activity of orally administered PXD101 to patients with lymphoma
Time Frame: throughout the trial
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throughout the trial
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: enquiries@topotarget.com, Onxeo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
December 18, 2006
First Submitted That Met QC Criteria
December 18, 2006
First Posted (Estimate)
December 19, 2006
Study Record Updates
Last Update Posted (Estimate)
July 8, 2015
Last Update Submitted That Met QC Criteria
July 7, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
- lymphoma
- colorectal cancer
- lung cancer
- Solid tumors
- mesothelioma
- Breast cancer
- Prostate cancer
- Ovarian cancer
- kidney cancer
- bladder cancer
- head and neck cancer
- thyroid cancer
- B-cell lymphoma
- Carcinoma, Non-Small-Cell Lung
- Osteosarcoma
- T-cell lymphoma
- sarcoma
- Esophageal Neoplasms
- Leiomyosarcoma
- Liposarcoma
- Chondrosarcoma
- Otorhinolaryngologic Neoplasms
- Fibrosarcoma
- PXD101
- Hodgkins Disease
- Carcinoma, Small Cell
- Adenosarcoma
- belinostat
- Hemangiosarcoma
- mesothelioma, cystic
- Mixed Tumor, Mesodermal
- Parathyroid Neoplasms
Additional Relevant MeSH Terms
Other Study ID Numbers
- PXD101-CLN-9
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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