Study of Oral Darinaparsin in Patients With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: darinaparsin

• Registration Number: NCT01139346
• Lead Sponsor: Alaunos Therapeutics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-04
• Study First Submitted QC: 2010-06-04
• Study First Posted: 2010-06-08
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-18
• Last Update Posted: 2012-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
oral darinaparsin	darinaparsin	open label, single arm, dose escalation

Primary Outcome Measures

Name	Time	Method
Determine Toxicity Profile	One Year	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
Determine Maximum Tolerated Dose	One Year	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
Determine the preliminary activity/efficacy	One Year	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
Determine Pharmacokinetic profile	One Year	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