- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01435863
A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)
August 11, 2015 updated by: Solasia Pharma K.K.
A Phase 1 Study of SP-02L (Darinaparsin for Injection) in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)
The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy in Japanese patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
17
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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Fukuoka, Japan
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Tokyo, Japan
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Aichi
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Nagoya, Aichi, Japan
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Miyagi
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Sendai, Miyagi, Japan
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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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Japanese patients aged ≥ 20 years of age at the day of obtaining the informed consent
- Patients with histologically confirmed diagnosis of the following:
- Peripheral T-cell Lymphoma, not otherwise specified (PTCL-NOS)
- Anaplastic Large Cell Lymphoma (ALCL ALK-positive/negative)
- Angioimmunoblastic T-cell Lymphoma (AITL)
- Have relapsed or refractory to at least one prior systemic chemotherapy for the above disease (currently requiring therapy)
- Have at least 1 evaluable lesion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 3 months
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: SP-02L
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Cohort 1: Darinaparsin 200 mg/m2 for 5 consecutive days every 28 days (5 days therapy, 23 days no therapy is one cycle).
Subjects may start from Cycle 1 and continue to a maximum of 4 cycles of treatment.
Cohort 2: Darinaparsin 300 mg/m2 for 5 consecutive days every 28 days (5 days therapy, 23 days no therapy is one cycle).
Subjects may start from Cycle 1 and continue to a maximum of 4 cycles of treatment.
Cohort 3: Darinaparsin 300 mg/m2 for 5 consecutive days every 21 days (5 days therapy, 16 days no therapy is one cycle).
Subjects may start from Cycle 1 and continue to a maximum of 4 cycles of treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Incidence of dose-limiting toxicity and adverse events
Time Frame: 12 or 16 weeks
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12 or 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor response (overall response)
Time Frame: 2 and 4 cycles
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2 and 4 cycles
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Plasma concentration-time profile
Time Frame: 0, 0.5, 1, 2, 4, 8 hours post-dose on Day 1 and 5, and 0 hour on Day 2, 3, 4, 6, 8 and 15
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Cmax, Area under Curve, tmax, t1/2, Clearance and Volume of distribution
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0, 0.5, 1, 2, 4, 8 hours post-dose on Day 1 and 5, and 0 hour on Day 2, 3, 4, 6, 8 and 15
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
September 1, 2011
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
September 13, 2011
First Submitted That Met QC Criteria
September 15, 2011
First Posted (Estimate)
September 19, 2011
Study Record Updates
Last Update Posted (Estimate)
August 13, 2015
Last Update Submitted That Met QC Criteria
August 11, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SP-02L01
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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BeiGeneCompletedCutaneous T-cell Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Adult Nasal Type Extranodal NK/T-cell Lymphoma | Anaplastic Large Cell Lymphoma, ALK-Positive | Extranodal NK/T-cell Lymphoma, Nasal Type | Peripheral T Cell Lymphoma | Extranodal NK/T-cell Lymphoma | Peripheral... and other conditionsChina, Taiwan, Germany, France, Canada, Italy
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Solasia Pharma K.K.Synex Consulting Korea Ltd.CompletedPeripheral T-cell LymphomaKorea, Republic of
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Solasia Pharma K.K.CompletedPeripheral T-Cell LymphomaHong Kong, Japan, Taiwan, Korea, Republic of
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H. Lee Moffitt Cancer Center and Research InstituteUniversity of Miami; James and Esther King Biomedical Research ProgramCompletedSmoking Cessation | Tobacco DependenceUnited States
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University of Wisconsin, MadisonCompletedIntubation; Difficult or Failed | Laryngeal MasksUnited States
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