Safety Study of a Liposomal Docetaxel Formulation in Patients With Solid Tumors Who Have Failed Previous Therapies
A Phase I, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Intravenously Administered ATI-1123, a Liposomal Docetaxel Formulation, on an Every 3 Week Schedule, in Patients With Advanced Solid Tumors
1 other identifier
interventional
29
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2009
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 30, 2009
CompletedFirst Posted
Study publicly available on registry
December 31, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedSeptember 6, 2012
September 1, 2012
1.8 years
December 30, 2009
September 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To determine the (MTD) and (DLTs) of ATI-1123 administered every 3 weeks, over a range of doses in patients with advanced solid tumors.
Duration of study
To establish the dose recommended for future phase II studies with ATI-1123.
End of Study
Secondary Outcomes (2)
To establish the pharmacokinetics of intravenously administered ATI-1123.
Cycle 1 (various time points within the cycle)
To observe patients for any evidence of antitumor activity of ATI-1123 by objective radiographic assessment.
Every 8 weeks
Study Arms (1)
ATI-1123
EXPERIMENTALInterventions
Dose escalation starting at 15 mg/m2 given once every 3 weeks via IV
Eligibility Criteria
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
- +7 more criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Mary Crowley Cancer Research Centers (MCCRC)
Dallas, Texas, 75230, United States
Cancer Therapy and Research Center (CTRC)
San Antonio, Texas, 78229, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony W Tolcher, MD
South Texas Accelerated Research Therapeutics (START)
- PRINCIPAL INVESTIGATOR
John Nemunaitis, MD
Mary Crowley Cancer Research Center
- STUDY CHAIR
Jon M Rogers, MD
Azaya Therapeutics, Inc (Medical Monitor)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2009
First Posted
December 31, 2009
Study Start
December 1, 2009
Primary Completion
October 1, 2011
Study Completion
December 1, 2011
Last Updated
September 6, 2012
Record last verified: 2012-09