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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00591422
• Other study ID #: SGC1001
• Status: Active, not recruiting
• Phase: Phase 1
• First received: December 26, 2007
• Last updated: July 18, 2012
• Start date: August 2007
• Est. completion date: June 2013

Study information

• Verified date: July 2012
• Source: Ziopharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Cancer
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• ZIO-101-C (Darinaparsin)
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ziopharm

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicities		6 months	Yes
Secondary	pharmacokinetics		6 months	No