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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Azaya Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01041235
First received: December 30, 2009
Last updated: September 4, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Solid Tumor
Breast Cancer
Ovarian Cancer
Pancreatic Cancer
Non-Small Cell Lung
Drug: ATI-1123 (active drug = docetaxel)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Azaya Therapeutics, Inc.:

Primary Outcome Measures:
  • To determine the (MTD) and (DLTs) of ATI-1123 administered every 3 weeks, over a range of doses in patients with advanced solid tumors. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
  • To establish the dose recommended for future phase II studies with ATI-1123. [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To establish the pharmacokinetics of intravenously administered ATI-1123. [ Time Frame: Cycle 1 (various time points within the cycle) ] [ Designated as safety issue: Yes ]
  • To observe patients for any evidence of antitumor activity of ATI-1123 by objective radiographic assessment. [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: December 2009
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ATI-1123 Drug: ATI-1123 (active drug = docetaxel)
Dose escalation starting at 15 mg/m2 given once every 3 weeks via IV
Other Names:
  • ATI-1123
  • ATI1123
  • Docetaxel
  • Docetaxol
  • Taxotere

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041235

Locations
United States, Texas
Mary Crowley Cancer Research Centers (MCCRC)
Dallas, Texas, United States, 75230
Cancer Therapy and Research Center (CTRC)
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Azaya Therapeutics, Inc.
Investigators
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)
  More Information

Additional Information:
No publications provided

Responsible Party: Azaya Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01041235     History of Changes
Other Study ID Numbers: ATI1123-101
Study First Received: December 30, 2009
Last Updated: September 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Azaya Therapeutics, Inc.:
Solid Neoplasms
Carcinoma
Breast
Ovarian
Ovary
Pancreas
Pancreatic
Lung
NSCLC
Non Small Cell Lung
Prostate
Gastric
Head and Neck

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Ovarian Neoplasms
Pancreatic Neoplasms
Adnexal Diseases
Breast Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms by Site
Ovarian Diseases
Pancreatic Diseases
Skin Diseases
Urogenital Neoplasms
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 20, 2014