Study of Oral Darinaparsin in Patients With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

Phase I Study of Oral Darinaparsin in Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139346
• Other study ID #: SGC1004
• Status: Completed
• Phase: Phase 1
• First received: June 4, 2010
• Last updated: July 18, 2012
• Start date: June 2010
• Est. completion date: April 2012

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

This study is a Phase I, dose escalation study of oral darinaparsin for the treatment of advanced solid tumors. Eligible patients could have received any amount of previous therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with histological or cytological confirmation of advanced cancer (solid tumor) that is refractory to standard therapies for their condition;

• Men and women of =18 years of age;

• ECOG performance score =2

• Eligible subjects with solid tumors MUST have at least one measurable lesion as defined by RECIST 1.1 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;

• 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:

• Arsenic allergy.

• New York Heart Association (NYHA) functional class =3 myocardial infarction (see Appendix 3) 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.

• Patients 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, Alzheimer's, and other neurological disorders.

• Anticancer chemotherapy or immunotherapy during the study or within four 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.

• Major surgery within 4 weeks of start of Study Drug dosing.

• Other Investigational drug therapy during this trial within four weeks prior to 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 patient's participation in the study or evaluation of Study results.

• Any condition that is unstable or could jeopardize the safety of the patient and his/her compliance in the Study.

Study Design

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

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• darinaparsin
dose escalating, starting at 200 mg twice per day for 21 days continuous followed by a 7 day rest per cycle.

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	Determine Toxicity Profile	a primary outcome measure is to determine the toxicity profile of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle	One Year	Yes
Primary	Determine Maximum Tolerated Dose	a primary outcome measure is to determine the maximum tolerated dose of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle	One Year	Yes
Primary	Determine the preliminary activity/efficacy	a primary outcome measure is to determine the preliminary activity/efficacy of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle	One Year	No
Primary	Determine Pharmacokinetic profile	a primary outcome measure is to determine the pharmacokinetic profile of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle	One Year	Yes