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palifosfamide-tris

Phase 3

Advanced Solid Tumors | Small molecule | Oncology |Alaunos Therapeutics, Inc.|Last Updated: Sep 29, 2026

Development status

Highest phase Phase 3 (NCT01168791)
Phase scored for TCRTPhase 1
Registered trials 5 across 1 sponsor since Jul 2008

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

palifosfamide-tris · 2 trials · 9 indications

Phase 1 2
NCT01340547Effect on QTc, Pharmacokinetics, Safety, and Preliminary Efficacy of Single-agent Palifosfamide-tris in Subjects With Advanced Solid TumorsAdvanced Solid Tumors
COMPLETED24 Analytics
NCT01242072Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With MalignanciesMalignancy
COMPLETED22 Analytics
PHASE1COMPLETED
Effect on QTc, Pharmacokinetics, Safety, and Preliminary Efficacy of Single-agent Palifosfamide-tris in Subjects With Advanced Solid Tumors
Advanced Solid TumorsUnlock trial analytics
PHASE1COMPLETED
Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies
MalignancyUnlock trial analytics

Study Endpoints

Primary Endpoints

ECG QTc intervals of patients who receive palifosfamide-tris
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
Cycle 1, Day 1, 2, 3, 4, 8

To assess the pharmacokinetic profile of single-agent palifosfamide-tris.

Assess the safety profile
21 Days

Adverse events, vital signs, physical examination, laboratory data and concomitant medications

Secondary Endpoints

Safety and tolerability of palifosfamide-tris measured in amount, type, severity and relatedness of Adverse Events
Duration of time patient is on study, expected average of 5 months
Preliminary efficacy of palifosfamide-tris as it pertains to cancer tumor growth
Duration of time patient is on study, expected average of 5 months
Determine the maximum tolerated dose
Up to 21 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single ArmOTHERSingle Arm, non-blinded, non-randomized
PaCEEXPERIMENTALPalifosfamide, Carboplatin and Etoposide

Interventions

NameTypeDescription
palifosfamide-trisDRUGpalifosfamide-tris IV infusion of 150 mg/m2 on Days 1, 2 and 3 every three weeks (21 day cycle)
Normal SalineDRUG0.9% Normal Saline 250 ml IV infusion on Cycle 1 Day -1
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion criteria: 1. Male or female subjects, age ≥ 18 years, who have provided written informed consent prior to completing any study specific procedure. 2. Histologically or cytologically confirmed solid tumor that has progressed following available standard therapies or for which no standard t...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")