Safety Study for Intravenous (IV) AC480 (AC480IV) to Treat Advanced Solid Tumors
|ClinicalTrials.gov Identifier: NCT01245543|
Recruitment Status : Withdrawn (Clinical investigations have been discontinued and transfer to BMS 3/24/2015)
First Posted : November 22, 2010
Last Update Posted : November 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: AC480IV Drug: Docetaxel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label, Phase 1 Trial to Evaluate the Safety and Pharmacokinetic Parameters of a 2-day Pulse of Intravenous (IV) AC480 (AC480IV) Administered as Monotherapy and in Combination With Docetaxel in Patients With Advanced Solid Tumors|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||June 2013|
Dose range finding study
Docetaxel will be administered intravenously, initially as monotherapy and subsequently in combination with docetaxel immediately following AC480IV administration.
Other Name: Taxol
Dose range finding study in subjects with solid tumors
AC480IV will be administered as an infusion using a dose escalation design.
Other Name: AC480IV•Esylate
- Determine the safety and tolerability, including the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD), of a 2-day pulse of AC480IV both as monotherapy and in combination with docetaxel in patients with advanced solid tumor malignancies. [ Time Frame: 18 months ]The primary outcome of the study will be safety and tolerability of the study treatment as measured by physical examinations, adverse events, clinical chemistry evaluations, ECG assessments and the report of dose-limiting toxicity as outlined in the protocol.
- Determine the pharmacokinetic (PK) parameters (Cl, Vd, Cmax, Clast, AUClast, AUCinf, t1/2, etc.) of AC480IV and docetaxel as monotherapy and in combination. [ Time Frame: Measured at specified timepoints during 1st and/or 2nd cycles of treatment. ]This study is designed to evaluate the safety and PK parameters of AC480IV as monotherapy and also in combination with docetaxel.
- Determine any preliminary evidence of efficacy of AC480IV as monotherapy or in combination with docetaxel by assessing tumor response and time to disease progression. [ Time Frame: 18 months ]Efficacy assessments will be completed within 7 days after the end of Cycle 3 and then every 3 cycles thereafter. Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) will be used to assess radiographic response.
- Evaluate HER profile and Ras mutation status in patients' tumors [ Time Frame: Measured in specified dosing cohorts at various timepoints during 1st and/or 2nd cycles of treatment. ]If possible, patients with tumors known to express HER receptors, such as head and neck, lung adenocarcinoma, upper GI/esophageal, and breast cancers will be included.
- Evaluate whether AC480IV has anti-metabolic activity in the tumor microenvironment. [ Time Frame: Measured in specified dosing cohorts at various timepoints during Part 1 of this study. ]Tumor metabolism will be assessed by comparing pre-dose and postdose assessments.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01245543
|United States, California|
|University of California San Francisco (UCSF)|
|San Francisco, California, United States, 94118|
|United States, Texas|
|South Texas Accelerated Research Therapeutics (START)|
|San Antonio, Texas, United States, 78229|
|Study Director:||Guy Gammon, MB BS, MRCP||Interim Chief Medical Officer / Ambit Biosciences Corporation|