Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT01041235
Status:
COMPLETED
Last Update Posted:
2012-09-06
First Post:
2009-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of a Liposomal Docetaxel Formulation in Patients With Solid Tumors Who Have Failed Previous Therapies
Sponsor:
Azaya Therapeutics, Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: