A Phase II Evaluation of ADXS11-001 (IND #13,712) in the Treatment of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix (NCT# 01266460).
Principal Investigator
Warner Huh, MD
Status
Terminated
Date Opened To Accrual
May 23 2011
Date Closed to Accrual
October 24 2016
Date of Study Termination
July 17 2020
Disease Site
Gynecologic [GY]
Cervix
Phase
II
Developmental Therapeutics
No
Primary Objective
To evaluate the tolerability, safety and nature and degree of toxicity of ADXS11-001 by the numbers of patients with dose limiting toxicities (DLTs) and adverse events as assessed by the CTCAE v4.0.
To assess the activity of ADXS11-001 for patients with persistent or recurrent carcinoma of the cervix with the frequency of patients who survive for at least 12 months after initiating therapy.
Patient Population
To evaluate the tolerability, safety and nature and degree of toxicity of ADXS11-001 by the numbers of patients with dose limiting toxicities (DLTs) and adverse events as assessed by the CTCAE v4.0.
To assess the activity of ADXS11-001 for patients with persistent or recurrent carcinoma of the cervix with the frequency of patients who survive for at least 12 months after initiating therapy.
Target Accrual
90
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.