Solid TumorsPhase 1NCT00591136
Phase I Study of Indibulin in Patients With Solid Tumors
A Phase 1 study testing indibulin in people with Solid Tumors, run by Alaunos Therapeutics at 2 sites in Netherlands.
Trial summary
Dose-finding and pharmacokinetic trial of orally administered Indibulin to patients 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
- 47 participants
- Where
- 2 sitesNetherlands
- Study dates
- Apr 2003to Sep 2008
- 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
- Male or female patient, >= 18 years of age.
- Histologically/cytologically proven solid malignant tumor, for which standard treatment of proven efficacy are not or no longer available.
- Performance status 0-2 ECOG/WHO.
- Life expectancy > 3 months.
- Able and willing to undergo blood sampling for pharmacokinetics.
- Written informed consent.
Who cannot join
- Safety concerns:
- Any non-compensated or uncontrolled non-malignant condition, such as, symptomatic heart failure, active tuberculosis or any other chronic or active infection.
- History of allergic reaction to one of the ingredients of the trial medication.
- Clinically relevant abnormality in organ function as evidenced by any of the following pa¬ra¬meters:
- White blood cell count: < 3.0 x 109/l ANC: < 1.5 x 109/l
- Thrombocytes: < 100 x 109/l
Show all 21Show fewer
- Hemoglobin < 6.0 mM
- Bilirubin (total): > 1.5 times upper limit of normal range
- ASAT, ALAT: > 2.5 times upper limit of normal range unless related to metastases in which case > 5 times upper normal limit is allowed
- Creatinine (serum) > 135 µmol/l (> 1.5 mg/100ml) OR
- Creatinine clearance: < 50 ml/min (calculated according to modified Cockcroft and Gault)
- Breast feeding, pregnancy or planned pregnancy. A reliable method of contraception must be used in men and in women of childbearing potential during the study and for 3 months after last study drug administration.
- Lack of suitability for the trial:
- Concomitant treatment with any other investigational drugs or exposure to another investigational agent within the last 4 weeks prior to study specific screening procedures (period should be extended if the patient has received any drug which is known to have de¬layed toxicity or prolonged half-life).
- Active peptic ulcer or any GI condition that could alter absorption or motility.
- Chronic use of H2-antagonists or proton pump inhibitors.
- Any other cancer treatment during the study or administered within the last 4 weeks (6 weeks for nitrosoureas, mitomycin C, high-dose carboplatin or extensive radiotherapy) before start of study treatment, except irradiation of non-target lesions for symptom relief and bi-phosphonate treatment of bone metastases.
- Clinically symptomatic brain metastases or leptomeningeal disease.
- Neurological or psychiatric disease or drug or alcohol abuse which would interfere with the patients proper completion of the protocol assignment.
- Administrative reasons:
- Anticipated non-availability for study visits/procedures.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Dose-finding and Pharmacokinetic Trial of Orally Administered D-24851 to Patients With Solid Tumors
Dose-finding and pharmacokinetic trial of orally administered Indibulin to patients with solid tumors.
- Conditions
- Solid Tumors
- Being tested
- indibulin
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, daily dosing for 14 days every 3 weeks, for up to 4 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: 4 months
Secondary outcomes (1)
pharmacokinetics
Measured: 4 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 startApr 2003
- Primary completionSep 2008
- Study completionSep 2008
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaunos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Lewis, MD, PhD, Study director, ZIOPHARM Oncology, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591136
- Sponsor's protocol ID
- IBL1001
- Status last verified
- Jul 2012
- First submitted
- 26 Dec 2007
- Last updated
- 19 Jul 2012
- 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 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-finding and Pharmacokinetic Trial of Orally Administered D-24851 to Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00591136
- Acronym / sponsor ID
- IBL1001
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Alaunos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (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-finding and pharmacokinetic trial of orally administered Indibulin to patients with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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 (6 listed)
- Male or female patient, >= 18 years of age.
- Histologically/cytologically proven solid malignant tumor, for which standard treatment of proven efficacy are not or no longer available.
- Performance status 0-2 ECOG/WHO.
- Life expectancy > 3 months.
- Able and willing to undergo blood sampling for pharmacokinetics.
Key exclusion criteria (21 listed)
- Safety concerns:
- Any non-compensated or uncontrolled non-malignant condition, such as, symptomatic heart failure, active tuberculosis or any other chronic or active infection.
- History of allergic reaction to one of the ingredients of the trial medication.
- Clinically relevant abnormality in organ function as evidenced by any of the following pa¬ra¬meters:
- White blood cell count: < 3.0 x 109/l ANC: < 1.5 x 109/l
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, daily dosing for 14 days every 3 weeks, for up to 4 months | Drug | Single Arm |
Primary outcome
toxicities
Time frame: 4 months
1 secondary outcome
pharmacokinetics
Time frame: 4 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 19 Jul 2012.
- 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 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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, PhD study director
ZIOPHARM Oncology, Inc
2 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 Solid Tumors, run by Alaunos Therapeutics at 2 sites in Netherlands.
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 6 inclusion and 21 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 19 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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: 4 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 NCT00591136, 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 19 Jul 2012.