Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Dallas, Texas 75246


Purpose:

The study of Dariniparsin (ZIO-101-C) in Advanced Solid Tumors and Non-Hodgkin's Lymphomas


Criteria:

Inclusion Criteria 1. Patients with non-Hodgkin's Lymphomas that are refractory to standard therapies for their condition.(As of protocol amendment 6.0 dated 8/26/2009) 2. Men and women of ≥ 18 years of age. 3. ECOG performance score ≤ 2 (see Appendix 4). 4. Eligible subjects with lymphomas must have measurable disease as defined by the revised International Working Group response criteria (Appendix 7) 5. Life expectancy ≥ 12 weeks. 6. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements, to be conducted <2 weeks prior to Baseline: - Creatinine ≤ 2X upper limit of normal (ULN) OR a calculated creatinine clearance ≥ 50 cc/min - Total bilirubin ≤ 2X ULN - Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3X ULN - Granulocytes in peripheral blood ≥1 x 109/L, hemoglobin ≥8.5 g/dL, and platelets ≥50,000 /µL 7. Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee (IEC/IRB) having jurisdiction over the site. Exclusion Criteria 1. New York Heart Association (NYHA) functional class ≥3 myocardial infarction (see Appendix 5) within 6 months. 2. 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. 3. Pregnant and/or lactating female. (Women of childbearing age must use effective contraception from Screening through the duration of Study participation.) 4. Uncontrolled systemic infection (documented with microbiological studies). 5. Metastatic brain or meningeal tumors. 6. Patients with seizure disorder requiring medication (such as anti-epileptics). 7. History of confusion or dementia or neurological condition that could mask a potential adverse response to Study Drug which may include transient ischemic attack, Parkinson's disease, thrombotic or hemorrhagic stroke, Alzheimers, and other neurological disorders. 8. 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). 9. Radiotherapy during study or within 3 weeks of Study entry. 10. Surgery within 4 weeks of start of Study Drug. 11. Investigational drug therapy outside of this trial during or within 4 weeks of Study entry. 12. 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. 13. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of Study results. 14. Any condition that is unstable or could jeopardize the safety of the patient and his/her compliance in the Study. 15. Arsenic allergy.


Study is Available At:


Original ID:

SGC1001


NCT ID:

NCT00591422


Secondary ID:


Study Acronym:


Brief Title:

Phase I Study of Oral Darinaparsin (ZIO-101-C)in Advanced Solid Tumors and Non-Hodgkin's Lymphomas


Official Title:

Phase I Study of Oral Darinaparsin (ZIO-101-C) in Advanced Solid Tumors and Non-Hodgkin's Lymphomas


Overall Status:

Active, not recruiting


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

ZIOPHARM


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, I


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

23


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jonathan Lewis, MD, PhD
Study Director
ZIOPHARM

Study Dates

Start Date:August 2007
Completion Date:June 2013
Completion Type:Anticipated
Primary Completion Date:June 2013
Primary Completion Type:Anticipated
Verification Date:July 2012
Last Changed Date:July 18, 2012
First Received Date:December 26, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:Toxicities
Time Frame:6 months
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:pharmacokinetics
Time Frame:6 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:ZIO-101-C (Darinaparsin)
Description:Capsule, Dose escalation study from 100 mg to 1000 mg (or Maximum Tolerated Dose). 3 times weekly (>36 hours between doses) for 3 weeks with 1 week rest.
Arm Name:Single Arm
Other Name:ZIO-101-C

Study Arms

Study Arm Type:Experimental
Arm Name:Single Arm

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:ZIOPHARM

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.