- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00592163
Phase I Study of Oral ZIO-101-C in Advanced Solid Tumors and Lymphomas
July 18, 2012 updated by: Alaunos Therapeutics
A Phase I Study of Oral ZIO-101-C in Advanced Solid Tumors and Lymphomas
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
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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Quebec
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Montreal, Quebec, Canada
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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:
- Subjects with histological or cytological confirmation of advanced cancer that is refractory to standard therapies for their condition.
- Men and women of ≥18 years of age.
- ECOG performance score ≤2.
- 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. Eligible subjects with lymphomas must have measurable disease as defined by the revised International Working Group response criteria.
- Life expectancy ≥12 weeks.
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements, to be conducted <2 weeks prior to Baseline:
- Creatinine ≤1.5 × upper limit of normal (ULN) OR a calculated creatinine clearance ≥50 cc/min
- Total bilirubin ≤2 × ULN
- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤3 × ULN
- Granulocytes in peripheral blood ≥1 × 109/L, hemoglobin ≥10 g/dL, and platelets ≥50,000 /μL
- Adequate vascular access for repeated blood sampling.
- Men and women of childbearing potential must agree to use effective contraception from Screening through the duration of Study participation.
- Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee (IEC/IRB) having jurisdiction over the site.
Exclusion Criteria:
- New York Heart Association (NYHA) functional class ≥3 myocardial infarction within 6 months
- Uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; a QTc ≥450 msec; or a ≥Grade 2 atrioventricular (AV) block or left bundle branch block (LBBB); or documented history of prolonged QTc.
- Pregnant and/or lactating women.
- Uncontrolled systemic infection (documented with microbiological studies).
- Metastatic brain or meningeal tumors.
- Subjects with seizure disorder requiring medication (such as anti-epileptics).
- History of confusion or dementia or neurological condition that could mask a potential adverse response to the Study Drug, which may include transient ischemic attack, Parkinson's disease, thrombotic or hemorrhagic stroke, Alzheimers, and other neurological disorders.
- Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of Study entry (mitomycin C or nitrosureas should not be given within 6 weeks of Study entry).
- Radiotherapy during study or within 3 weeks of Study entry.
- Surgery within 4 weeks of start of Study Drug dosing.
- Investigational drug therapy outside of this trial during or within 4 weeks of Study entry.
- History of 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.
- Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of Study results.
- Any condition that is unstable or could jeopardize the safety of the subject and his/her compliance in the Study.
- Arsenic allergy.
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 |
---|---|
Experimental: Single Arm
|
Dose Escalation study, 200 mg - 900 mg, cumulative daily dose split to be taken BID 7 times a week (>8 hours between doses) for 3 weeks followed by 1 week of rest
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
toxicities
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pharmacokinetics
Time Frame: 6 months
|
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
December 1, 2007
Primary Completion (Anticipated)
June 1, 2013
Study Completion (Anticipated)
June 1, 2013
Study Registration Dates
First Submitted
December 26, 2007
First Submitted That Met QC Criteria
December 26, 2007
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
- SGC1002
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 Advanced Solid Tumors
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AmgenCompletedCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced MalignancyUnited States, Australia
-
NantCell, Inc.CompletedQUILT-2.016: Study of AMG 479 With Biologics or Chemotherapy for Subjects With Advanced Solid TumorsCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced Malignancy
-
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
-
Hoffmann-La RocheCompletedSolid Tumors, Advanced Solid TumorsUnited States
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Esperance Pharmaceuticals IncCompletedAdvanced Solid Tumors | Solid TumorsUnited States
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Millennium Pharmaceuticals, Inc.CompletedAdvanced Solid Tumors, Neoplasms, Advanced SolidHungary
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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
-
Vividion Therapeutics, Inc.RecruitingAdvanced Solid Tumors | Advanced Hematologic TumorsUnited States, Australia
Clinical Trials on ZIO-101-C (Darinaparsin)
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Alaunos TherapeuticsUnknownAdvanced CancerUnited States
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Alaunos TherapeuticsCompleted
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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
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Alaunos TherapeuticsUnknownHEPATOCELLULAR CARCINOMAUnited States
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Alaunos TherapeuticsCompletedAdvanced Solid TumorsUnited States
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Alaunos TherapeuticsCompletedHematologic Neoplasms | Non-Hodgkin's Lymphoma | Bone Marrow NeoplasmsUnited States
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Alaunos TherapeuticsWithdrawn
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M.D. Anderson Cancer CenterAlaunos TherapeuticsCompleted
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Alaunos TherapeuticsUnknownMultiple MyelomaUnited States