- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00591396
A Phase I Trial of ZIO-101 in Solid Tumors
July 18, 2012 updated by: Alaunos Therapeutics
A Phase I Trial of ZIO-101 in Solid Tumors: Protocol # SGL1002
A Phase I Trial of ZIO-101 (Darinaparsin) in Solid Tumors
Study Overview
Study Type
Interventional
Enrollment (Actual)
40
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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Texas
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Houston, Texas, United States
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- Subjects with histological confirmation solid malignancy refractory to conventional standard therapies for their condition
- Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions MUST not have been in a previously irradiated field or injected with biological agents
- Pediatric subjects will be eligible at the discretion of the primary investigator.
- ECOG performance status score ≤ 2
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative blood or urine pregnancy test within 1 week before beginning treatment. Sexually active men must also use acceptable contraceptive methods
- Subjects must provide written informed consent prior to treatment
- At least 4 weeks from prior completion of prior therapy to day 1 of study drug
- Baseline toxicity assessment ≤ grade 1 except treatment induced alopecia (NCI Common Toxicity Criteria version 3.0)
Evidence of adequate multi-organ functional status as reflected by the following clinical laboratory values:
- Serum creatinine ≤ 2 times the upper normal limit OR a calculated creatinine clearance ≥ 50 cc/min
- Total bilirubin ≤ 2 times the upper normal limit
- Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal
- Granulocytes in peripheral blood greater than or equal to 1 x 10(9) per liter, hemoglobin greater than or equal to 8.5 g/dL, and platelets greater than or equal to 50,000 /microL
Exclusion Criteria
- Uncontrolled systemic infection (documented with microbiological studies)
- Active heart disease as defined by an acute myocardial infarction within the previous 6 months before starting therapy, stable or unstable angina, clinically significant arrhythmia requiring medical management, OR New York Heart Association Classification of Functional Activities. Class 3: Subject has marked limitation in activities due to symptoms, even during less-than-ordinary activity and is comfortable only at rest OR Class 4: Severe limitations. Subject experiences symptoms even while at rest
- Concomitant therapy for solid cancer
- Pregnant subjects and those who are breast-feeding
- History of an invasive second primary malignancy diagnosed within the previous 3 years except for Stage I Endometrial/Cervical Carcinoma or Prostate Carcinoma treated surgically, and non-melanoma skin cancer
- Documented personal or family history of prolonged QT syndrome
- 12 lead electrocardiogram with a corrected QT interval > 460 milliseconds
- History of confusion or dementia
- History of seizure disorder
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: Single Arm
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Dose Escalation of ZIO-101 (Darinaparsin) given daily for five consecutive days to be repeated every 28 days for up to six months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
toxicities
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pharmacokinetics
Time Frame: 6 months
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
July 1, 2005
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
December 26, 2007
First Submitted That Met QC Criteria
January 10, 2008
First Posted (Estimate)
January 11, 2008
Study Record Updates
Last Update Posted (Estimate)
July 19, 2012
Last Update Submitted That Met QC Criteria
July 18, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SGL1002
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.
Clinical Trials on Solid Tumors
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Incyte CorporationRecruitingA Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid TumorsAdvanced Solid Tumors | Solid Tumors | Metastatic Solid TumorsUnited States, Spain, United Kingdom, France, Italy, Denmark, Switzerland
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National Cancer Institute (NCI)RecruitingSolid Tumor | Refractory Solid Tumors | Malignant Solid Tumors | Other Neoplasms Solid Tumors | Pediatric Solid TumorUnited States
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Hoffmann-La RocheCompletedSolid Tumors, Advanced Solid TumorsUnited States
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Esperance Pharmaceuticals IncCompletedAdvanced Solid Tumors | Solid TumorsUnited States
-
Incyte Biosciences Japan GKCompletedAdvanced Solid Tumors | Metastatic Solid TumorsJapan
-
Memorial Sloan Kettering Cancer CenterKyowa Hakko Kirin Pharma, Inc.CompletedAdvanced Solid Tumors | Metastatic Solid TumorsUnited States
-
Bristol-Myers SquibbCompletedAdvanced Solid Tumors | Metastatic Solid TumorsKorea, Republic of, Canada, Australia
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Cancer Institute and Hospital, Chinese Academy...RecruitingRefractory Solid Tumors | Relapsed Solid TumorsChina
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Genentech, Inc.RecruitingAdvanced Solid Tumors | Metastatic Solid TumorsCanada, Korea, Republic of, United States, Brazil, Australia, Argentina, Spain, New Zealand, Poland
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NeuPharma, Inc.RecruitingLocally Advanced Solid Tumors | Metastatic Solid TumorsUnited States
Clinical Trials on ZIO-101 (Darinaparsin)
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Alaunos TherapeuticsCompleted
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Alaunos TherapeuticsCompletedLymphoma | Multiple Myeloma | Acute Leukemia | Chronic Myeloproliferative Disease | Chronic Lymphoproliferative Disease | Poor-risk Myelodysplasia (MDS)United States
-
Alaunos TherapeuticsUnknownAdvanced CancerUnited States
-
Alaunos TherapeuticsUnknownHEPATOCELLULAR CARCINOMAUnited States
-
Alaunos TherapeuticsCompletedHematologic Neoplasms | Non-Hodgkin's Lymphoma | Bone Marrow NeoplasmsUnited States
-
Alaunos TherapeuticsUnknownAdvanced Solid Tumors | LymphomasCanada
-
Alaunos TherapeuticsCompletedAdvanced Solid TumorsUnited States
-
Alaunos TherapeuticsWithdrawn
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Alaunos TherapeuticsUnknownMultiple MyelomaUnited States
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M.D. Anderson Cancer CenterAlaunos TherapeuticsCompleted