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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

Phase 1
18 Years
Not Enrolling
Solid Tumor, Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Non-Small Cell Lung

Thank you

Trial Information

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

The majority of advanced stage human cancers are fatal if not treated promptly and
aggressively. Standard treatments include chemotherapy, radiation therapy and surgery.
Docetaxel, the active ingredient in ATI-1123 and the FDA approved drug Taxotere, is a
chemotherapy given by IV to patients to treat various types of cancers.

Docetaxel is a poorly water soluble semi-synthetic taxane analog commonly used in the
treatment of a variety of solid tumors including non-small cell lung, prostate, breast,
gastric and head and neck cancer. Because of its poor water solubility it is formulated with
co-solvents that can potentially contribute to treatment related adverse events such as
hypersensitivity. Current taxane formulations often complicate drug delivery and can alter
both pharmacokinetic and toxicity profiles.

Results from nonclinical evaluations show that ATI-1123 retains the antineoplastic activity
of docetaxel while removing the need for unwanted solvents like Tween 80. The
administration of ATI-1123 versus other docetaxel chemotherapy formulations is expected to
reduce hypersensitivity reactions (redness, swelling, itching at the infusion site),
eliminate the requirement for premedications, have a broader therapeutic index, and enhance
systemic docetaxel exposure.

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the (MTD) and (DLTs) of ATI-1123 administered every 3 weeks, over a range of doses in patients with advanced solid tumors.

Outcome Time Frame:

Duration of study

Safety Issue:


Principal Investigator

Anthony W Tolcher, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

South Texas Accelerated Research Therapeutics (START)


United States: Food and Drug Administration

Study ID:




Start Date:

December 2009

Completion Date:

December 2011

Related Keywords:

  • Solid Tumor
  • Breast Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • Non-Small Cell Lung
  • Solid Neoplasms
  • Carcinoma
  • Breast
  • Ovarian
  • Ovary
  • Pancreas
  • Pancreatic
  • Lung
  • Non Small Cell Lung
  • Prostate
  • Gastric
  • Head and Neck
  • Breast Neoplasms
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Neoplasms



Cancer Therapy and Research Center (CTRC)San Antonio, Texas  78229
Mary Crowley Cancer Research Centers (MCCRC)Dallas, Texas  75230