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Phase I/II Study of a Novel Indibulin Dosing Schedule for the Treatment of Metastatic Breast Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Metastatic Breast Cancer

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Trial Information

Phase I/II Study of a Novel Indibulin Dosing Schedule for the Treatment of Metastatic Breast Cancer

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

- 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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I- Maximum Tolerated Dose

Outcome Description:

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

Outcome Time Frame:

Throughout Cycle 1 (28 days)

Safety Issue:


Principal Investigator

Jonathan J. Lewis, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

ZIOPHARM, Oncology, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

March 2010

Completion Date:

May 2013

Related Keywords:

  • Metastatic Breast Cancer
  • breast cancer
  • Indibulin
  • unresectable, locally advanced breast cancer
  • Breast Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Northwest Cancer Specialists Vancouver, Washington  98664
The West Clinic Memphis, Tennessee  38120
Evergreen Hematology Oncology Spokane, Washington  99218