Advanced Solid TumorsPhase 1NCT01340547
Effect on QTc, Pharmacokinetics, Safety, and Preliminary Efficacy of Single-agent Palifosfamide-tris in Subjects With Advanced Solid Tumors
A Phase 1 study testing palifosfamide-tris and Normal Saline in people with Advanced Solid Tumors, run by Alaunos Therapeutics at 3 sites in United States.
Trial summary
This is an open-label study of palifosfamide-tris administered intravenously on Days 1, 2, and 3 of a 21-day cycle to subjects with advanced solid tumors. Enrolled subjects will receive a placebo-control infusion on Day -1 and then commence palifosfamide-tris study treatment 24 hours later on Day 1. 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?
- palifosfamide-tris and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2011to 1 Aug 2012
- 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 subjects, age ≥ 18 years, who have provided written informed consent prior to completing any study specific procedure.
- Histologically or cytologically confirmed solid tumor that has progressed following available standard therapies or for which no standard therapy exist.
- Measurable or non-measurable disease by RECIST version 1.1
- Must have recovered from toxic effects of prior cancer treatment to ≤ Grade1per CTCAE v4.0, with the exception of any alopecia.
- ECOG Performance Status of 0 or 1.
- Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements:
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- Hemoglobin ≥9.0 g/dL.
- Absolute neutrophil count (ANC) ≥1,500/uL.
- Platelet count ≥100,000/uL.
- Total bilirubin ≤1.5 x upper limit of normal (ULN)
- ALT and AST ≤2.5 x ULN. For subjects with documented liver metastases, ALT and AST ≤5×ULN.
- International Normalized Ratio (INR) and activated partial thromboplastin time [PTT] <1.5 x ULN, if not therapeutically anticoagulated. Subjects who are being therapeutically anticoagulated with an agent such as Coumadin (warfarin sodium) or subcutaneous heparin may be included provided there is no prior evidence of underlying abnormality in coagulation parameters, screening test results are in appropriate therapeutic range, and anticoagulation regimen is stable and closely monitored.
- Estimated glomerular filtration rate (eGRF) ≥60 mL/minute/1.73 m2.
- Male and female subjects must agree to use a highly reliable method of birth control (expected failure rate less than 5% per year) from the screening visit through 28 days after the last dose of study drug.
Who cannot join
- Subjects who have received prior chemotherapy, radiation therapy or any investigational agent within 28 days prior to the first dose of study drug.
- Unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a subject and/or their compliance with the protocol. Examples include, but are not limited to, unstable angina, congestive heart failure, recent (within 2 months of screening) myocardial infarction, ongoing maintenance therapy for life-threatening ventricular arrhythmia, uncontrolled asthma, HIV/AIDS without adequate anti-viral therapy, evidence of hepatic pathology due to or consistent with infection with a chronic hepatitis virus, uncontrolled major seizure disorder, or electrolyte imbalances.
- Presence of, or history of any illness or injury to the urinary tract (renal or post-renal) which may make the subject more susceptible to acute renal insufficiency in the case of potential renal adverse events. Types of injury or illness might include a history of polycystic renal disease, nephrectomy, renal transplant, acute or chronic renal failure.
- Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 2 weeks of the first dose of study drug. Subjects with HIV who are on effective anti-viral therapy or subjects with chronic herpes infections who use intermittent suppressive antiviral therapy for viral outbreaks may be included.
- Major surgery within 4 weeks prior to start of treatment.
- Documented symptomatic brain metastases. Screening for brain lesions by CT or MRI is not required for potential subjects; however, if there are any neurological signs or symptoms consistent with brain metastases, then a brain CT or MRI should be performed as clinically indicated.
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- Currently pregnant or nursing.
- Subjects with implantable pacemaker or automatic implantable cardioverter defibrillator.
- Conditions that make the screening ECG repolarization difficult to interpret, or showing significant abnormalities. This includes, but is not limited to: high degree AV block, pace-maker, atrial fibrillation or flutter, prolonged QTc >500ms on repeat measurements (e.g., 2 out of 3 ECGs), or bradycardia (defined as ≤ 50 beats/minute).
- Subjects who will be receiving medications that prolong the QT interval with a risk of causing Torsades de Pointes during the time period beginning 1 week prior to and during the Intensive ECG monitoring period (i.e., Cycle 1, Day -8 through Day 8).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Dallas, Texas, 75230
Study site
Houston, Texas, 77030
Study site
San Antonio, Texas, 78229
About this study
Official title: A Phase I Multicenter, Open-label Study of the Effect on QTc, Pharmacokinetics, Safety, and Preliminary Efficacy of Single-agent Palifosfamide-tris in Subjects With Advanced Solid Tumors
This is an open-label study of palifosfamide-tris administered intravenously on Days 1, 2, and 3 of a 21-day cycle to subjects with advanced solid tumors. Enrolled subjects will receive a placebo-control infusion on Day -1 and then commence palifosfamide-tris study treatment 24 hours later on Day 1.
Time-matched, intensive ECG monitoring will occur during and following placebo and palifosfamide-tris infusions on Days -1, 1, 2, 3 and 8. Generation of ECG data for study analysis will be performed in a blinded fashion at a central ECG laboratory.
Blood and urine sampling to characterize the pharmacokinetics of palifosfamide-tris will be performed on Days 1 through 8 of Cycle 1.
- Conditions
- Advanced Solid Tumors
- Being tested
- palifosfamide-tris, Normal Saline
- Keywords
- Phase I, Safety, PK, ECG QTc, Efficacy, Palifosfamide-tris, non-randomized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palifosfamide-trisDrug
Also called isophosphoramide mustard-tris, Zymafos (TM)
palifosfamide-tris IV infusion of 150 mg/m2 on Days 1, 2 and 3 every three weeks (21 day cycle)
Normal SalineDrug
0.9% Normal Saline 250 ml IV infusion on Cycle 1 Day -1
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Single Arm, non-blinded, non-randomized Receives: Drug: palifosfamide-tris; Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG QTc intervals of patients who receive palifosfamide-tris
To assess the effect of single-agent palifosfamide-tris on QTc intervals.
Measured: Cycle 1 Days -1,1, 2, 3,8
Blood sampling to characterize the pharmacokinetics of palifosfamide-tris
To assess the pharmacokinetic profile of single-agent palifosfamide-tris.
Measured: Cycle 1, Day 1, 2, 3, 4, 8
Secondary outcomes (2)
Safety and tolerability of palifosfamide-tris measured in amount, type, severity and relatedness of Adverse Events
To assess the safety and tolerability of single-agent palifosfamide-tris.
Measured: Duration of time patient is on study, expected average of 5 months
Preliminary efficacy of palifosfamide-tris as it pertains to cancer tumor growth
To obtain preliminary efficacy data as defined by objective response rate (ORR); progression-free survival (PFS); and durability of response in subjects with advanced solid tumors when treated with single-agent palifosfamide-tris.
Measured: Duration of time patient is on study, expected average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startJun 2011
- Primary completion1 Aug 2012
- Study completion1 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaunos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340547
- Sponsor's protocol ID
- IPM1005
- Status last verified
- Sep 2026
- First submitted
- 13 Apr 2011
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Multicenter, Open-label Study of the Effect on QTc, Pharmacokinetics, Safety, and Preliminary Efficacy of Single-agent Palifosfamide-tris in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01340547
- Acronym / sponsor ID
- IPM1005
- Conditions
- Advanced Solid Tumors
- Keywords
- Phase I, Safety, PK, ECG QTc, Efficacy, Palifosfamide-tris, non-randomized
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alaunos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- 1 Aug 2012 (actual)
- Study completion
- 1 Aug 2012 (actual)
- First posted
- 22 Apr 2011 (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 an open-label study of palifosfamide-tris administered intravenously on Days 1, 2, and 3 of a 21-day cycle to subjects with advanced solid tumors. Enrolled subjects will receive a placebo-control infusion on Day -1 and then commence palifosfamide-tris study treatment 24 hours later on Day 1.
Time-matched, intensive ECG monitoring will occur during and following placebo and palifosfamide-tris infusions on Days -1, 1, 2, 3 and 8. Generation of ECG data for study analysis will be performed in a blinded fashion at a central ECG laboratory.
Blood and urine sampling to characterize the pharmacokinetics of palifosfamide-tris will be performed on Days 1 through 8 of Cycle 1.
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 | Other | Drug: palifosfamide-tris, Drug: Normal SalineSingle Arm, non-blinded, non-randomized |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female subjects, age ≥ 18 years, who have provided written informed consent prior to completing any study specific procedure.
- Histologically or cytologically confirmed solid tumor that has progressed following available standard therapies or for which no standard therapy exist.
- Measurable or non-measurable disease by RECIST version 1.1
- Must have recovered from toxic effects of prior cancer treatment to ≤ Grade1per CTCAE v4.0, with the exception of any alopecia.
- ECOG Performance Status of 0 or 1.
Key exclusion criteria (10 listed)
- Subjects who have received prior chemotherapy, radiation therapy or any investigational agent within 28 days prior to the first dose of study drug.
- Unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a subject and/or their compliance with the protocol. Examples include, but are not limited to, unstable angina, congestive heart failure, recent (within 2 months of screening) myocardial infarction, ongoing maintenance therapy for life-threatening ventricular arrhythmia, uncontrolled asthma, HIV/AIDS without adequate anti-viral therapy, evidence of hepatic pathology due to or consistent with infection with a chronic hepatitis virus, uncontrolled major seizure disorder, or electrolyte imbalances.
- Presence of, or history of any illness or injury to the urinary tract (renal or post-renal) which may make the subject more susceptible to acute renal insufficiency in the case of potential renal adverse events. Types of injury or illness might include a history of polycystic renal disease, nephrectomy, renal transplant, acute or chronic renal failure.
- Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 2 weeks of the first dose of study drug. Subjects with HIV who are on effective anti-viral therapy or subjects with chronic herpes infections who use intermittent suppressive antiviral therapy for viral outbreaks may be included.
- Major surgery within 4 weeks prior to start of treatment.
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 |
|---|---|---|
| palifosfamide-trisAlso: isophosphoramide mustard-tris, Zymafos (TM)palifosfamide-tris IV infusion of 150 mg/m2 on Days 1, 2 and 3 every three weeks (21 day cycle) | Drug | Single Arm |
| Normal Saline0.9% Normal Saline 250 ml IV infusion on Cycle 1 Day -1 | Drug | Single Arm |
Primary outcome
ECG QTc intervals of patients who receive palifosfamide-tris
Time frame: Cycle 1 Days -1,1, 2, 3,8
To assess the effect of single-agent palifosfamide-tris on QTc intervals.
Blood sampling to characterize the pharmacokinetics of palifosfamide-tris
Time frame: Cycle 1, Day 1, 2, 3, 4, 8
To assess the pharmacokinetic profile of single-agent palifosfamide-tris.
2 secondary outcomes
Safety and tolerability of palifosfamide-tris measured in amount, type, severity and relatedness of Adverse Events
Time frame: Duration of time patient is on study, expected average of 5 months
Preliminary efficacy of palifosfamide-tris as it pertains to cancer tumor growth
Time frame: Duration of time patient is on study, expected average of 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 29 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 palifosfamide-tris and Normal Saline 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 14 inclusion and 10 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 29 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 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?
ECG QTc intervals of patients who receive palifosfamide-tris (time frame: Cycle 1 Days -1,1, 2, 3,8). 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?
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 29 Sep 2026.