This trial is active, not recruiting.

Condition metastatic breast cancer
Treatment indibulin
Phase phase 1/phase 2
Sponsor Ziopharm
Collaborator Memorial Sloan-Kettering Cancer Center
Start date March 2010
End date May 2013
Trial size 60 participants
Trial identifier NCT01113970, IBL2001


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
open label, single arm, unblinded
indibulin ZIO-301
Indibulin given orally once a day for 5 days followed by a 9 day rest

Primary Outcomes

Phase I- Maximum Tolerated Dose
time frame: Throughout Cycle 1 (28 days)
Phase II- Progression Free Survival
time frame: 4 months

Secondary Outcomes

Phase I- Number of participants with Adverse Events as a measure of safety and tolerability
time frame: Duration of study, approximately one year
Phase I- Toxicity
time frame: Cycle 1 (28 days), and duration of study (approximately one year)
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)
Phase II- Overall Response Rate
time frame: At the end of Cycles 4 and 6 (approximately 4 months and 6 months respectively)
Phase II- Rate of Stable Disease
time frame: Phase II- greater than 6 months
Phase II- Number of patients with Adverse Events as a measure of safety and tolerability
time frame: Throughout study, approximately one year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologic or cytologic confirmation of invasive carcinoma of the breast. - Clinical evidence of metastatic disease or locally advanced disease not amenable to curative therapy. - Measurable or non-measurable lesions according to the RECIST Version 1.1 2009. - Any number of prior endocrine, biologic or chemotherapy regimens is permitted. All previous chemotherapy and biologic therapy must have been discontinued at least 3 weeks prior to beginning study drug. Endocrine therapy may not be used concurrently with protocol treatment. All acute toxic effects (excluding alopecia or neuropathy) of any prior therapy must have resolved to NCI CTC (version 4.0) Grade ≤ 1 or to baseline - Prior radiation therapy is permitted. - ECOG performance status of 0, 1 or 2. - Age ≥ 18 years - Life expectancy ≥ 12 weeks - Patients with HER2-positive (IHC 3+ or FISH-amplified) breast cancer must have received trastuzumab or have a contradiction to receiving HER2- targeted therapy (such as abnormal left ventricular ejection fraction)as determined by the treating physician. - Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: - Creatinine ≤ 1.5x upper limit of normal (ULN) - Total bilirubin ≤ 1.5x ULN - ALT or AST ≤ 2.5x ULN - ANC ≥ 1.5 x10(9)/L - Platelets ≥ 100 x10(9)/L - Hemoglobin ≥ 9g/dL - Subjects of childbearing potential must agree to use a barrier method of contraception throughout the study and for 3 months after study drug administration. Exclusion Criteria: - Pregnant or nursing women may not participate. - Serious, uncontrolled, concurrent infection. - Patients with symptomatic CNS metastases that remain untreated by radiation therapy are excluded from this trial. The presence of asymptomatic, previously irradiated, stable brain metastases for at least 3 months are not grounds for trial exclusion. - Presence of uncontrolled gastrointestinal malabsorption syndrome. - Any chemotherapy, radiotherapy or breast cancer directed biologic therapy during the study or within 3 weeks of study start. Mitomycin C or nitrosureas should not be given within 6 weeks of study entry. No washout period is required for hormonal therapies. - Concurrent radiation therapy is not permitted during treatment on protocol. - History of an invasive second primary malignancy diagnosed within the previous 3 years, except for Stage I endometrial or cervical carcinoma or prostate carcinoma treated surgically, and non-melanoma skin cancer. - Any medical, psychological or social condition that may interfere with the subject's ability to safely participate in the study. - Unwillingness to give written informed consent or unwillingness to participate or inability to comply with the protocol for the duration of the study. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures are necessary for participation in this clinical trial.

Additional Information

Official title Phase I/II Study of a Novel Indibulin Dosing Schedule for the Treatment of Metastatic Breast Cancer
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Ziopharm.