Metastatic Breast CancerPhase 1NCT01113970
Study of a Novel Indibulin Dosing Schedule for the Treatment of Metastatic Breast Cancer
A Phase 1 study testing Indibulin in people with Metastatic Breast Cancer, run by Alaunos Therapeutics at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Indibulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Apr 2010to 21 May 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 17Show fewer
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The West Clinic
Memphis, Tennessee, 38120
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Evergreen Hematology Oncology
Spokane, Washington, 99218
Northwest Cancer Specialists
Vancouver, Washington, 98684
About this study
Official title: Phase I/II Study of a Novel Indibulin Dosing Schedule for the Treatment of Metastatic Breast Cancer
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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Indibulin
- Keywords
- breast cancer, Indibulin, unresectable, locally advanced breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndibulinDrug
Also called ZIO-301, Zybulin(TM)
Indibulin given orally once a day for 5 days followed by a 9 day rest
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | open label, single arm, unblinded Receives: Drug: Indibulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I- Maximum Tolerated Dose
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
Measured: Throughout Cycle 1 (28 days)
Phase II- Progression Free Survival
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.
Measured: 4 months
Secondary outcomes (6)
Phase I- Number of participants with Adverse Events as a measure of safety and tolerability
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
Measured: Duration of study, approximately one year
Phase I- Toxicity
To describe the Cycle I and overall toxicity rates of indibulin (5-9) using the NCI CTC version 3.
Measured: 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.
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.
Measured: During Cycle 1 (28 days)
Phase II- Overall Response Rate
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.
Measured: At the end of Cycles 4 and 6 (approximately 4 months and 6 months respectively)
Phase II- Rate of Stable Disease
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.
Measured: Phase II- greater than 6 months
Phase II- Number of patients with Adverse Events as a measure of safety and tolerability
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.
Measured: Throughout study, approximately one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study start6 Apr 2010
- Primary completion3 Sep 2012
- Study completion21 May 2013
Why it stopped: Sponsor business decision: enrollment closed after the Phase 1 dose escalation, before an MTD was reached. The Phase 2 portion was not conducted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaunos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Responsible party
- Sponsor
- Investigators
- Jonathan J. Lewis, MD, PhD, Study director, ZIOPHARM, Oncology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113970
- Sponsor's protocol ID
- IBL2001
- Status last verified
- Sep 2026
- First submitted
- 8 Apr 2010
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Kapoor S, Srivastava S, Panda D. Indibulin dampens microtubule dynamics and produces synergistic antiproliferative effect with vinblastine in MCF-7 cells: Implications in cancer chemotherapy. Sci Rep. 2018 Aug 17;8(1):12363. doi: 10.1038/s41598-018-30376-y.
PubMed 30120268
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of a Novel Indibulin Dosing Schedule for the Treatment of Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01113970
- Acronym / sponsor ID
- IBL2001
- Conditions
- Metastatic Breast Cancer
- Keywords
- breast cancer, Indibulin, unresectable, locally advanced breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor business decision: enrollment closed after the Phase 1 dose escalation, before an MTD was reached. The Phase 2 portion was not conducted.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Alaunos TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Study start
- 6 Apr 2010 (actual)
- Primary completion
- 3 Sep 2012 (actual)
- Study completion
- 21 May 2013 (actual)
- First posted
- 30 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Indibulinopen label, single arm, unblinded |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IndibulinAlso: ZIO-301, Zybulin(TM)Indibulin given orally once a day for 5 days followed by a 9 day rest | Drug | Single Arm |
Primary outcome
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.
6 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
Results and safety
The study was stopped early (reason given: Sponsor business decision: enrollment closed after the Phase 1 dose escalation, before an MTD was reached. The Phase 2 portion was not conducted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Derived from this study: PubMed 30120268Kapoor S, Srivastava S, Panda D. Indibulin dampens microtubule dynamics and produces synergistic antiproliferative effect with vinblastine in MCF-7 cells: Implications in cancer chemotherapy. Sci Rep. 2018 Aug 17;8(1):12363. doi: 10.1038/s41598-018-30376-y.
- ZIOPHARM Oncology, Inc. home pageLink provided by the sponsor.
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan J. Lewis, MD, PhD study director
ZIOPHARM, Oncology, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Indibulin in people with Metastatic Breast Cancer, run by Alaunos Therapeutics at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor business decision: enrollment closed after the Phase 1 dose escalation, before an MTD was reached. The Phase 2 portion was not conducted.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I- Maximum Tolerated Dose (time frame: Throughout Cycle 1 (28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01113970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.