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

Completed · Phase 1

Conditions studied: Solid Tumor, Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Non-Small Cell Lung

In brief

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.

Key facts

Study ID

NCT01041235

Run by

Azaya Therapeutics, Inc.

People needed

29

Starts

2009-12-01

Expected to finish

2011-12-01

Last updated by the study team

2012-09-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Mary Crowley Cancer Research Centers (MCCRC) — Dallas, Texas, United States
• Cancer Therapy and Research Center (CTRC) — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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