Advanced CancerPhase 1NCT00607711
Study of Oral Palifosfamide Tris in Solid Tumors
A Phase 1 study testing oral palifosfamide tris in people with Advanced Cancer, run by Alaunos Therapeutics.
Trial summary
The study of maximum tolerated dose and safety of oral palifosfamide tris capsules in advanced, refractory, solid tumors 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?
- oral palifosfamide tris
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Nov 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 that is refractory to standard therapies for their condition.
- Men and women of ≥18 years of age.
- Life expectancy of at least 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance score ≤2 (see Appendix 4).
- Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines. 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.
- 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× upper limit of normal (ULN) OR a calculated creatinine clearance ≥70 cc/min
- Total bilirubin ≤2×ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN
- Granulocytes in peripheral blood ≥2.0×109/L, hemoglobin ≥8.5 g/dL, and platelets ≥50,000/µL
- Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee (IEC/IRB) having jurisdiction over the site.
- Men and women of childbearing potential must use effective contraception from Screening through his/her duration of study participation.
- Women of childbearing potential must have a negative serum pregnancy test prior to entering the study.
Who cannot join
- New York Heart Association (NYHA) functional Class ≥III myocardial infarction (see Appendix 5) within 6 months.
- Uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; a QTc ≥450 msec; or a ≥Grade 2 atrioventricular (AV) block or left bundle branch block (LBBB); or documented history of prolonged QTc.
- Pregnancy and/or lactation.
- Uncontrolled systemic infection (documented with microbiological studies).
- Inadequate renal function as defined by the presence of one or more of the following:
- Creatinine clearance (CrCl) <70 cc/min
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- Serum creatinine >1.5×ULN
- Prior nephrectomy
- Urinary tract obstruction
- 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 study or within 3 weeks of study entry.
- Surgery within 4 weeks of start of study drug.
- Other investigational drug therapy outside of this trial during or within 4 weeks of study entry.
- History of 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 study results.
- Any condition that is unstable or could jeopardize the safety of the subject and his/her compliance in the study.
About this study
Official title: A Phase I Study of Oral Palifosfamide Tris in Advanced, Refractory, Solid Tumors
The study of maximum tolerated dose and safety of oral palifosfamide tris capsules in advanced, refractory, solid tumors
- Conditions
- Advanced Cancer
- Being tested
- oral palifosfamide tris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral palifosfamide trisDrug
Capsule(s) given daily for 15 days followed by a 6 day rest. This is a dose escalation arm.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Drug: oral palifosfamide tris |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicities
Measured: 9 months
Secondary outcomes (1)
Safety
Measured: 9 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 startMar 2008
- Primary completionNov 2009 (estimated)
- Study completionNov 2009 (estimated)
Why it stopped: IND was withdrawn
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaunos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sachin Shah, MD, Study director, ZIOPHARM Oncology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607711
- Sponsor's protocol ID
- IPC1001
- Status last verified
- Sep 2026
- First submitted
- 24 Jan 2008
- 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 Study of Oral Palifosfamide Tris in Advanced, Refractory, Solid Tumors
- ClinicalTrials.gov ID
- NCT00607711
- Acronym / sponsor ID
- IPC1001
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IND was withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alaunos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- 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 maximum tolerated dose and safety of oral palifosfamide tris capsules in advanced, refractory, 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: oral palifosfamide tris |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects with histological or cytological confirmation of advanced cancer that is refractory to standard therapies for their condition.
- Men and women of ≥18 years of age.
- Life expectancy of at least 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance score ≤2 (see Appendix 4).
- Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines. 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.
Key exclusion criteria (16 listed)
- New York Heart Association (NYHA) functional Class ≥III myocardial infarction (see Appendix 5) within 6 months.
- Uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; a QTc ≥450 msec; or a ≥Grade 2 atrioventricular (AV) block or left bundle branch block (LBBB); or documented history of prolonged QTc.
- Pregnancy and/or lactation.
- Uncontrolled systemic infection (documented with microbiological studies).
- Inadequate renal function as defined by the presence of one or more of the following:
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 |
|---|---|---|
| oral palifosfamide trisCapsule(s) given daily for 15 days followed by a 6 day rest. This is a dose escalation arm. | Drug | Single arm |
Primary outcome
Toxicities
Time frame: 9 months
1 secondary outcome
Safety
Time frame: 9 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
Sachin Shah, MD study director
ZIOPHARM Oncology, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing oral palifosfamide tris in people with Advanced Cancer, run by Alaunos Therapeutics.
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 13 inclusion and 16 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: withdrawn, 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.
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 withdrawn before enrolling participants, so there are no results.
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: 9 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 29 Sep 2026.