NCT00057395UnknownPhase 1
A Phase I/II Study of Aroplatin™ in Patients With Advanced Solid Malignancies
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Aronex Pharmaceuticals
- Enrollment
- 40
- Locations
- 2
Study Overview
Brief Summary
To determine the rate of response and the duration of the response following therapy with Aroplatinin patients with advanced solid malignancies.
Detailed Description
Primary Objective:
- Determine response rate (RR; complete and partial response [CR, PR]) and duration after therapy with Aroplatin™ in patients with advanced solid malignancies.
Secondary Objective:
- Determine the safety and tolerability of Aroplatin
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Advanced solid malignancies;
- •Amenable to therapy with DACH platinum agents;
- •Measurable disease (RECIST criteria);
- •ECOG performance score of 0-2;
- •Adequate hematopoietic, liver and renal function;
- •Adequate cardiac function (maximum of class II, NYHA);
- •Women of childbearing potential must have a negative urine or serum pregnancy test;
- •Signed written informed consent;
- •Subjects must be willing to be followed during the course of treatment/observation and follow-up.
Exclusion Criteria
- •No other active malignancies;
- •No prior therapy with oxaliplatin;
- •No known brain metastases;
- •Active, uncontrolled infection or other serious medical illnesses;
- •Not using or have used any investigational therapy during four weeks before start of protocol treatment.
Investigators
Study Sites (2)
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