Advanced Solid TumorsPhase 1NCT00726687
Phase 1b Study of Indibulin in Combination With Capecitabine in Advanced Solid Tumors
A Phase 1 study testing indibulin and capecitabine in people with Advanced Solid Tumors, run by Alaunos Therapeutics at 3 sites in United States.
Trial summary
This is a phase 1b study of Indibulin in combination with Capecitabine in advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- indibulin and capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Jun 2008to 29 Sep 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 advanced, histologically confirmed solid tumors for whom treatment with capecitabine is considered medically acceptable
- ≥18 years of age
- ECOG performance score ≤2 (see Appendix 2)
- Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines (see Appendix 3). Measurable lesions MUST NOT have been in a previously irradiated field or injected with biological agents.
- Life-expectancy ≥12 weeks
- No more than 2 prior chemotherapy regimens for metastatic disease
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- Subjects on prophylactic anticoagulation (i.e., low-dose warfarin) are eligible provided the coagulation parameter levels are as follows: prothrombin time (INR of prothrombin time) <1.1× institutional ULN
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted <2 weeks prior to Study Day 1:
- Creatinine ≤1.5 × upper limit of normal (ULN) OR a calculated creatinine clearance ≥1.50 cc/min (See Appendix 6 for calculation method)
- Total bilirubin ≤1.5×ULN
- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤2.5×ULN (<5×ULN for patients presenting with liver involvement)
- White blood cell count ≥3.0×109/L
- Absolute neutrophil count (ANC) ≥1.5×109/L
- Platelets ≥100×109/L
- Hemoglobin ≥10 g/dL
- Written informed consent in compliance with ZIOPHARM policies and the Institutional Review Board (IRB) having jurisdiction over the site
- Ability and willingness to undergo multiple venous punctures for serum PK sampling
- For the second phase of the trial (expanded cohort of 10), only capecitabine-naïve subjects will be included; prior therapy with 5-FU will be allowed
- Each man and woman of childbearing potential must agree to use a reliable method of contraception during the study and for 3 months following his or her last dose of study drug
Who cannot join
- New York Heart Association (NYHA) functional class ≥3 or myocardial infarction within 6 months (see Appendix 4)
- Severe renal impairment (creatinine clearance below 30 mL/min)
- Known dihydropyrimidine dehydrogenase deficiency (DPD)
- Any evidence of bleeding diathesis or coagulopathy
- International normalized ration (INR) >1.5, unless the subject is on full-dose warfarin
- Subjects on full-dose anticoagulants (e.g., warfarin) are eligible provided that both of the following criteria are met:
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- The subject must have an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular-weight heparin
- The subject must not have any active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
- Pregnancy and/or lactation. To be enrolled, each woman of childbearing potential must have a negative pregnancy test, which will be repeated at the end of the study.
- Uncontrolled systemic infection (documented with microbiological studies)
- Anticancer chemotherapy or immunotherapy within 4 weeks of study entry or at any time during the study or investigational drug therapy outside of this trial during or within 4 weeks of study entry
- Mitomycin C or nitrosureas should not be given within 6 weeks of study entry.
- Radiotherapy within 3 weeks of study entry or at any time during the study. For target lesions that have been radiated within 3 months of study entry, only those lesions with documented progression post radiation will be allowed.
- Surgery within 4 weeks of start of study drug dosing, excluding tumor biopsy for pharmacodynamic parameters
- 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 or medical, psychological or social conditions that may interfere with the subject's participation in the study or the evaluation of study results
- Any condition that is unstable or could jeopardize the safety of the subject and his/her compliance with study protocol
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Indianapolis, Indiana
Study site
Las Vegas, Nevada
Study site
Vancouver, Washington
About this study
This is a phase 1b study of Indibulin in combination with Capecitabine in advanced solid tumors.
Read the detailed description
The primary objective of the trial is to determine the maximum tolerated dose (MTD) and optimal dosing schedule of indibulin in combination with capecitabine in subjects diagnosed as having advanced solid tumors.
Secondary objectives include the determination of dose-limiting toxicity (DLT), safety and tolerability, and preliminary activity of this combination. In addition, biological activity of indibulin in combination with capecitabine will be evaluated.
Single arm, open label, Phase Ib, dose-escalation study of indibulin in combination with capecitabine in subjects with advanced histologically confirmed, solid tumors for which no standard therapy exists and for whom treatment with capecitabine is considered medically acceptable.
3 subjects will be treated at each dose level. When DLT occurs in 2 or more of 6 or fewer subjects, MAD has been reached and the dose will be reduced to the previous dosing level, which will be considered the MTD.
- Conditions
- Advanced Solid Tumors
- Being tested
- indibulin, capecitabine
- Keywords
- Cancer, Indibulin, Capecitabine, Xeloda
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indibulinDrug
indibulin, dose escalation, 400-600 mg taken twice every day
capecitabineDrug
Also called Xeloda
capecitabine, dose escalation, 875 mg/m2- 1250 mg/m2, taken twice daily for 14 days per 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| single | Experimental | Single arm designed to elicit Maximum Tolerated Dose Receives: Drug: indibulin; Drug: capecitabine |
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 posted1 Aug 2008 (estimated)
- Study start19 Jun 2008
- Primary completion29 Sep 2009
- Study completion29 Sep 2009
Why it stopped: No dose-limiting toxicity was observed. The sponsor concluded the study after 3 subjects at the higher dose level; the optional 10-subject expansion cohort was not enrolled.
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 Advanced 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaunos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Lewis, MD, Study chair, Alaunos Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726687
- Sponsor's protocol ID
- IBL1005
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2008
- Last updated
- 30 Sep 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Study of Indibulin in Combination With Capecitabine in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00726687
- Acronym / sponsor ID
- IBL1005
- Conditions
- Advanced Solid Tumors
- Keywords
- Cancer, Indibulin, Capecitabine, Xeloda
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No dose-limiting toxicity was observed. The sponsor concluded the study after 3 subjects at the higher dose level; the optional 10-subject expansion cohort was not enrolled.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Alaunos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2008 (actual)
- Primary completion
- 29 Sep 2009 (actual)
- Study completion
- 29 Sep 2009 (actual)
- First posted
- 1 Aug 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.
This is a phase 1b study of Indibulin in combination with Capecitabine in advanced solid tumors.
Detailed description
The primary objective of the trial is to determine the maximum tolerated dose (MTD) and optimal dosing schedule of indibulin in combination with capecitabine in subjects diagnosed as having advanced solid tumors.
Secondary objectives include the determination of dose-limiting toxicity (DLT), safety and tolerability, and preliminary activity of this combination. In addition, biological activity of indibulin in combination with capecitabine will be evaluated.
Single arm, open label, Phase Ib, dose-escalation study of indibulin in combination with capecitabine in subjects with advanced histologically confirmed, solid tumors for which no standard therapy exists and for whom treatment with capecitabine is considered medically acceptable.
3 subjects will be treated at each dose level. When DLT occurs in 2 or more of 6 or fewer subjects, MAD has been reached and the dose will be reduced to the previous dosing level, which will be considered the MTD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single | Experimental | Drug: indibulin, Drug: capecitabineSingle arm designed to elicit Maximum Tolerated Dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subjects with advanced, histologically confirmed solid tumors for whom treatment with capecitabine is considered medically acceptable
- ≥18 years of age
- ECOG performance score ≤2 (see Appendix 2)
- Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines (see Appendix 3). Measurable lesions MUST NOT have been in a previously irradiated field or injected with biological agents.
- Life-expectancy ≥12 weeks
Key exclusion criteria (17 listed)
- New York Heart Association (NYHA) functional class ≥3 or myocardial infarction within 6 months (see Appendix 4)
- Severe renal impairment (creatinine clearance below 30 mL/min)
- Known dihydropyrimidine dehydrogenase deficiency (DPD)
- Any evidence of bleeding diathesis or coagulopathy
- International normalized ration (INR) >1.5, unless the subject is on full-dose warfarin
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 |
|---|---|---|
| indibulinindibulin, dose escalation, 400-600 mg taken twice every day | Drug | single |
| capecitabineAlso: Xelodacapecitabine, dose escalation, 875 mg/m2- 1250 mg/m2, taken twice daily for 14 days per 21 day cycle | Drug | single |
Primary outcome
toxicities
Time frame: 6 months
1 secondary outcome
pharmacokinetics
Time frame: 6 months
Results and safety
The study was stopped early (reason given: No dose-limiting toxicity was observed. The sponsor concluded the study after 3 subjects at the higher dose level; the optional 10-subject expansion cohort was not enrolled.). Results are not available in the source record.
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 Advanced Solid Tumors
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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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 chair
Alaunos Therapeutics
3 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 and capecitabine in people with Advanced Solid Tumors, run by Alaunos Therapeutics at 3 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 19 inclusion and 17 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 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 3 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: No dose-limiting toxicity was observed. The sponsor concluded the study after 3 subjects at the higher dose level; the optional 10-subject expansion cohort was not enrolled.). 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?
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 NCT00726687, 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.