Phase I Study of Oral ZIO-101-C in Advanced Solid Tumors and Lymphomas

NCT00592163 | Unknown Phase 1

• 1 other identifier: SGC1002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I Study of Oral ZIO-101-C in Advanced Solid Tumors and Lymphomas

Conditions

Advanced Solid Tumors; Lymphomas

Keywords

Cancer; Arsenic

Outcome Measures

Primary Outcomes (1)

• toxicities

  6 months

Secondary Outcomes (1)

• pharmacokinetics

  6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: ZIO-101-C (Darinaparsin)

Interventions

ZIO-101-C (Darinaparsin) DRUG

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

Also known as: ZIO-101-C

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alaunos Therapeutics: lead

Study Sites (1)

Unknown Facility

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Lymphoma; Neoplasms

Interventions

darinaparsin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 11, 2008
• Study Start: December 1, 2007
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 19, 2012

Record last verified: 2012-07

Locations

CA (1)