Safety Study of a Liposomal Docetaxel Formulation in Patients With Solid Tumors Who Have Failed Previous Therapies

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety profile, including the maximum tolerated dose (MTD), of ATI-1123 a liposomal formulation of docetaxel, in the treatment of cancer patients with advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azaya Therapeutics, Inc.
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

• Understand and sign a written IRB-approved informed consent form.

• Have a histologically confirmed solid tumor.

• Have progressive disease following standard/approved chemotherapy or have no appropriate alternative therapy available.

• Have one or more tumors measurable or evaluable as outlined by modified RECIST or evaluable by CT or MRI scan.

• Have an ECOG performance status of ≤ 2.

• Have a life expectancy of at least 3 months.

• Be ≥ 18 years old.

• Have a negative pregnancy test (if female of childbearing potential)

• Demonstrate acceptable hepatic function:

• Bilirubin ≤ upper limit of normal (ULN)

• AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN

• Demonstrate acceptable renal function:

• Serum creatinine ≤ 1.5 x ULN, OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (Calculated according to the Cockroft and Gault formula)

• Demonstrate acceptable hematologic status:

• Absolute neutrophil count ≥ 1500/mm3

• Platelet count ≥ 100,000/mm3 (measured within 72 hours prior to initial dose)

• Hemoglobin ≥ 9 g/dL

• Demonstrate acceptable coagulation status:

• PT or INR within 1.5x ULN

• PTT within 1.5x ULN

• Have recovered from prior treatments (eg, surgery, radiation, chemotherapy, investigational therapies) sufficiently prior to Day 1 so that, in the opinion of the Investigator and/or Medical Monitor, the protocol objectives would not be compromised.

• Agree to use an effective contraceptive method (hormonal or barrier method; or abstinence) for the duration of the study and for 30 days after the last dose (for men and women of child-producing potential).

Exclusion Criteria:

• Have New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Day 1, unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG).

• Have a seizure disorder requiring anticonvulsant therapy.

• Have active CNS metastasis. Patients with a history of CNS metastases will be eligible if they have been treated and are stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on stable dose of steroids for ≥ 1 week prior to enrollment.

• Have severe, chronic obstructive pulmonary disease with hypoxemia.

• Have active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.

• Are pregnant or nursing.

• Have undergone radiation therapy, surgery, chemotherapy, or investigational therapy within 28 days prior to study entry (6 weeks for nitrosoureas or Mitomycin C).

• Are unwilling or unable to comply with procedures required in this protocol.

• Have a known history of infection with HIV, hepatitis B, or hepatitis C.

• Have a serious nonmalignant disease that, in the opinion of the Investigator and/or the Medical Monitor, could compromise protocol objectives.

• Are currently receiving any other investigational agent.

• Have exhibited allergic reactions to docetaxel, or a similar structural compound, biological agent, or formulation.