Advanced CancerPhase 1NCT00608803
Phase 1 Study of ZIO-201-T in Combination With Doxorubicin in Solid Tumors
A Phase 1 study testing ZIO-201-T and doxorubicin in people with Advanced Cancer, run by Alaunos Therapeutics at 2 sites in United States.
Trial summary
The study of safety of ZIO-201-T in combination with doxorubicin in the treatment of advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- ZIO-201-T and doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2008to Jan 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
- Age ≥18 years
- Histological or cytological documentation of cancer
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Ifosfamide and doxorubicin naïve
- Life expectancy of at least 12 weeks
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- Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements conducted within 7 days prior to dosing:Hemoglobin >9.0 g/dL, Absolute neutrophil count (ANC) >1,500/mm3,Platelet count ≥100,000/mm3,Total bilirubin <1.5×ULN,ALT and AST ≤2.5×ULN,Partial thromboplastin [PT]-INR/activated partial thromboplastin time [PTT] <1.5×ULN. Subjects who are being therapeutically anticoagulated with an agent such as Coumadin (warfarin sodium) or heparin are allowed provided there is no prior evidence of underlying abnormality in coagulation parameters. If an interaction between study drug and anticoagulant is suspected, anticoagulation monitoring should be increased as appropriate. Serum creatinine ≤ULN
- Written, informed consent must be obtained from a potential subject prior to the conduct of any study-specific procedures
- Male and female subjects must agree to use adequate birth control measures/barrier control during the course of the trial.
- Women of childbearing potential must have a pregnancy test performed within 7 days of the start of treatment.
Who cannot join
- Clinically evident congestive heart failure >Class II of the New York Heart Association (NYHA) guidelines
- Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia, or ventricular arrhythmias classified as Lown III, IV, or V
- History and/or signs of active coronary artery disease/ischemia with or without angina pectoris
- Serious myocardial dysfunction defined as scintigraphically (MUGA, myocardial scintigram) determined absolute left ventricular ejection fraction (LVEF) below 45% or an LVEF below the normal limit (one or both criteria is sufficient for exclusion)
- History of HIV infection
- Prior nephrectomy of history of urinary tract obstruction
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- Active, clinically serious infection requiring systemic antibacterial, antifungal, or antiviral therapy
- Any major surgery within 3 weeks prior to start of treatment
- Metastatic brain or meningeal tumors, unless the subject is >6 months from definitive therapy and has a negative imaging study within 4 weeks of study entry. In addition, the subject must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable, provided the dose is stable for 1 month prior to study start, and following screening radiographic studies).
- History of seizure disorder (a subject with seizures related to brain metastasis will be allowed provided he/she has been seizure-free for at least 2 months and meets the criteria defined above for inclusion of subjects with brain metastasis)
- Previous malignancy (except cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis, \& T1] or other malignancies curatively treated >3 years prior to entry)
- Pregnancy or lactation
- Substance abuse or 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 could jeopardize the safety of a subject and his/her compliance with the protocol requirements
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Houston, Texas, 77024
Study site
Santa Monica, California, 90403
About this study
Official title: A Phase I Study of ZIO-201-T in Combination With Doxorubicin in Subjects With Advanced, Refractory Solid Tumors for Which no Standard Therapy Exists and for Whom Treatment With Doxorubicin is Considered Medically Acceptable
The study of safety of ZIO-201-T in combination with doxorubicin in the treatment of advanced cancer.
- Conditions
- Advanced Cancer
- Being tested
- ZIO-201-T and doxorubicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZIO-201-T and doxorubicinDrug
ZIO-201-T given for 3 consecutive days every 3 weeks. Doxorubicin is given once every 3 weeks. This is a dose escalation arm.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Once the maximum tolerated dose (MTD) is determined, an expanded cohort of 20 subjects with advanced, ifosfamide and doxorubicin naive soft-tissue sarcoma subjects will be dosed at the MTD and evaluated for efficacy. Receives: Drug: ZIO-201-T and doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicities
Measured: 5 months
Secondary outcomes (1)
Pharmacokinetics
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alaunos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jonathan Lewis, MD, PhD, Study director, ZIOPHARM Oncology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608803
- Sponsor's protocol ID
- IPM1002
- Status last verified
- Sep 2009
- First submitted
- 22 Jan 2008
- Last updated
- 17 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of ZIO-201-T in Combination With Doxorubicin in Subjects With Advanced, Refractory Solid Tumors for Which no Standard Therapy Exists and for Whom Treatment With Doxorubicin is Considered Medically Acceptable
- ClinicalTrials.gov ID
- NCT00608803
- Acronym / sponsor ID
- IPM1002
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alaunos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 6 Feb 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.
The study of safety of ZIO-201-T in combination with doxorubicin in the treatment of advanced cancer.
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: ZIO-201-T and doxorubicinOnce the maximum tolerated dose (MTD) is determined, an expanded cohort of 20 subjects with advanced, ifosfamide and doxorubicin naive soft-tissue sarcoma subjects will be dosed at the MTD and evaluated for efficacy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years
- Histological or cytological documentation of cancer
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Ifosfamide and doxorubicin naïve
Key exclusion criteria (14 listed)
- Clinically evident congestive heart failure >Class II of the New York Heart Association (NYHA) guidelines
- Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia, or ventricular arrhythmias classified as Lown III, IV, or V
- History and/or signs of active coronary artery disease/ischemia with or without angina pectoris
- Serious myocardial dysfunction defined as scintigraphically (MUGA, myocardial scintigram) determined absolute left ventricular ejection fraction (LVEF) below 45% or an LVEF below the normal limit (one or both criteria is sufficient for exclusion)
- History of HIV infection
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 |
|---|---|---|
| ZIO-201-T and doxorubicinZIO-201-T given for 3 consecutive days every 3 weeks. Doxorubicin is given once every 3 weeks. This is a dose escalation arm. | Drug | Single arm |
Primary outcome
Toxicities
Time frame: 5 months
1 secondary outcome
Pharmacokinetics
Time frame: 5 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 17 Sep 2009.
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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, 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 ZIO-201-T and doxorubicin in people with Advanced Cancer, run by Alaunos Therapeutics at 2 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 10 inclusion and 14 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 17 Sep 2009. 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 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: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2009.