Study of a Novel Indibulin Dosing Schedule for the Treatment of Metastatic Breast Cancer
Recruitment status was: Active, not recruiting
This study is a Phase I/II trial of a novel Indibulin dosing schedule for the treatment of metastatic breast cancer. Eligible patients will have measurable or non-measurable, metastatic or unresectable, locally advanced breast cancer and may have received any number of prior therapies for their disease.
It is expected that the Phase I portion will enroll up to 20 patients and the Phase II portion will enroll up to 45 patients.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of a Novel Indibulin Dosing Schedule for the Treatment of Metastatic Breast Cancer|
- Phase I- Maximum Tolerated Dose [ Time Frame: Throughout Cycle 1 (28 days) ]The primary objective of the Phase I portion of the trial is to determine the maximum tolerated dose (MTD) of Indibulin when given for 5 days followed by a 9 day rest (5—9) using a standard 3+3 dose escalation scheme for the treatment of metastatic breast cancer
- Phase II- Progression Free Survival [ Time Frame: 4 months ]The primary objective of the Phase II portion of this trial is to examine the efficacy of indibulin for the treatment of metastatic breast cancer at the MTD established in Phase I. The primary endpoint is the proportion of patients who are progression free at 4 months when treated with Indibulin (5-9)at the MTD determined by the phase I portion of the trial.
- Phase I- Number of participants with Adverse Events as a measure of safety and tolerability [ Time Frame: Duration of study, approximately one year ]To evaluate the safety of Indibulin when administered for 5 days followed by a 9 day rest (5-9) in patients with metastatic breast cancer
- Phase I- Toxicity [ Time Frame: Cycle 1 (28 days), and duration of study (approximately one year) ]To describe the Cycle I and overall toxicity rates of indibulin (5-9) using the NCI CTC version 3.
- Phase I- Pharmacokinetics of indibulin in study subject plasma assessed in Cycle 1 Day 1 and Cycle 1 Day 5 per schedule below in Description section. [ Time Frame: During Cycle 1 (28 days) ]To evaluate pharmacokinetics (PK) of Indibulin (5-9) as it is assessed in Cycle 1 Day 1, Day 2, Day 5 and Day 8. Cycle 1 PK schedule as follows: Day 1 immediately pre dose, 1 hour, 2 hours, 4 hours, 6 hours and approximately 24 hours after start of infusion (Cycle 2 Day 1), Day 5 pre-dose and at anytime during Day 8.
- Phase II- Overall Response Rate [ Time Frame: At the end of Cycles 4 and 6 (approximately 4 months and 6 months respectively) ]To estimate the overall response rate (complete response and partial response)associated with Indibulin (5-9) schedule at eth MTD determined by the Phase I portion of this trial in patients with metastatic breast cancer.
- Phase II- Rate of Stable Disease [ Time Frame: Phase II- greater than 6 months ]To estimate the rate of stable disease greater than 6 months associated with the Indibulin (5-9) schedule at the MTD determined by the the Phase I portion of this trial in patients with metastatic breast cancer.
- Phase II- Number of patients with Adverse Events as a measure of safety and tolerability [ Time Frame: Throughout study, approximately one year ]To evaluate the safety of Indibulin when administered for 5 days followed by a 9 day rest (5-9) at the MTD determined by the Phase I portion of this trial in patients with metastatic breast cancer.
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: Single Arm
open label, single arm, unblinded
Indibulin given orally once a day for 5 days followed by a 9 day rest
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113970
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Tennessee|
|The West Clinic|
|Memphis, Tennessee, United States, 38120|
|United States, Washington|
|Evergreen Hematology Oncology|
|Spokane, Washington, United States, 99218|
|Northwest Cancer Specialists|
|Vancouver, Washington, United States, 98684|
|Study Director:||Jonathan J. Lewis, MD, PhD||ZIOPHARM, Oncology, Inc.|