Solid TumorsPhase 1NCT00591292
Phase I Study in Advanced Solid Tumors
A Phase 1 study testing indibulin in people with Solid Tumors, run by Alaunos Therapeutics at 1 site in United States.
Trial summary
Dose escalating study of orally administered indibulin at twice daily schedule in subjects with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- indibulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2007to 10 Mar 2009
- 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
- Subjects with histological or cytological confirmation of advanced cancer, refractory to standard therapies for their condition
- ≥ 18 years of age
- ECOG performance score ≤ 2 (see Appendix 3)
- Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines (See Appendix 4). If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions MUST not have been in a previously irradiated field or injected with biological agents.
- Life-expectancy ≥ 12 weeks
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted < 2 weeks prior to Baseline:
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- Creatinine ≤ 1.5 X upper limit of normal (ULN) OR a calculated creatinine clearance ≥ 50 cc/min
- Total bilirubin ≤ 1.5 X ULN
- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 X ULN
- White blood cell count ≥3.0 x 109/L
- Absolute Neutrophil Count (ANC) ≥1.5 x 109/L
- Platelets ≥100 x 109/L
- Hemoglobin ≥ 10 g/dL
- Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee with jurisdiction over the site.
Who cannot join
- New York Heart Association (NYHA) functional class ≥3 or myocardial infarction within 6 months (see Appendix 5)
- Uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation
- Pregnant and/or lactating female (a reliable method of contraception must be used in all men and in women of childbearing potential during the study and for 3 months after last study drug administration).
- Uncontrolled systemic infection (documented with microbiological studies)
- Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry. Mitomycin C or nitrosureas should not be given within 6 weeks of study entry.
- Radiotherapy during the study or within 3 weeks of study entry
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- Surgery within 4 weeks of start of study drug excluding tumor biopsy for pharmacodynamic parameters
- Investigational drug therapy outside of this trial during or within 4 weeks of study entry
- History of an invasive second primary malignancy diagnosed within the previous 3 years except for Stage I endometrial/cervical carcinoma or prostate carcinoma treated surgically, and non-melanoma skin cancer
- Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
- Any condition that is unstable or which could jeopardize the safety of the subject and his/her compliance with the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IBL1002:Phase I Study of Indibulin in Advanced Solid Tumors
Dose escalating study of orally administered indibulin at twice daily schedule in subjects with solid tumors.
- Conditions
- Solid Tumors
- Being tested
- indibulin
- Keywords
- cancer, tumor, solid tumor, advanced tumor
- Medical subject headings
- 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
Dose escalation of indibulin given twice daily for up to 6 months
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: indibulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
toxicities
Measured: 6 months
Secondary outcomes (1)
pharmacokinetics
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study start2 Jul 2007
- Primary completion17 Feb 2009
- Study completion10 Mar 2009
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 Solid TumorsStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaunos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Lewis, MD, Study director, Alaunos Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591292
- Sponsor's protocol ID
- IBL1002
- Status last verified
- Sep 2026
- First submitted
- 26 Dec 2007
- Last updated
- 30 Sep 2026
- Results posted
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IBL1002:Phase I Study of Indibulin in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00591292
- Acronym / sponsor ID
- IBL1002
- Conditions
- Solid Tumors
- Keywords
- cancer, tumor, solid tumor, advanced tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Alaunos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2007 (actual)
- Primary completion
- 17 Feb 2009 (actual)
- Study completion
- 10 Mar 2009 (actual)
- First posted
- 11 Jan 2008 (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.
Dose escalating study of orally administered indibulin at twice daily schedule in subjects with solid tumors.
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: indibulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects with histological or cytological confirmation of advanced cancer, refractory to standard therapies for their condition
- ≥ 18 years of age
- ECOG performance score ≤ 2 (see Appendix 3)
- Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines (See Appendix 4). If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions MUST not have been in a previously irradiated field or injected with biological agents.
- Life-expectancy ≥ 12 weeks
Key exclusion criteria (11 listed)
- New York Heart Association (NYHA) functional class ≥3 or myocardial infarction within 6 months (see Appendix 5)
- Uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation
- Pregnant and/or lactating female (a reliable method of contraception must be used in all men and in women of childbearing potential during the study and for 3 months after last study drug administration).
- Uncontrolled systemic infection (documented with microbiological studies)
- Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry. Mitomycin C or nitrosureas should not be given within 6 weeks of study entry.
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-301Dose escalation of indibulin given twice daily for up to 6 months | Drug | Single Arm |
Primary outcome
toxicities
Time frame: 6 months
1 secondary outcome
pharmacokinetics
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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.
Related trials for Solid Tumors
RecruitingPhase 2
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Carcinoma, Non-small-Cell Lung
RecruitingPhase 1
A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
Advanced Stage Solid Tumors
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
RecruitingPhase 1
A Study of JNJ-1761981 in Participants With Solid Tumors
Neoplasms
Not yet recruitingPhase 1
GD2IL18CART Combined With Bevacizumab for Relapsed and Refractory GD2-positive Solid Tumors
Neuroblastoma (NBL), Ewing Sarcoma
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 Lewis, MD study director
Alaunos Therapeutics
1 site 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 Solid Tumors, run by Alaunos Therapeutics at 1 site 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 14 inclusion and 11 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: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
toxicities (time frame: 6 months). 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 NCT00591292, 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 30 Sep 2026.