Palifosfamide Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 227

Clinical Trials

Palifosfamide, the active metabolite of ifosfamide, has been evaluated across multiple clinical trials spanning Phase 1 through Phase 3 for indications including advanced solid tumors, soft tissue sarcoma, extensive-stage small cell lung cancer, germ cell malignancies, and metastatic breast cancer. Conducted by academic institutions such as Indiana University and industrial sponsors like Alaunos Therapeutics, these studies report recruitment statuses ranging from suspended and terminated to unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01555710	UNKNOWN	Extensive-Stage Small Cell Lung Cancer	Alaunos Therapeutics	2012-05	PHASE3
NCT01808534	TERMINATED	Adult Central Nervous System Germ Cell Tumor; Adult Teratoma; Malignant Extragonadal Germ Cell Tumor; Malignant Extragonadal Non-Seminomatous Germ Cell Tumor; Extragonadal Seminoma; Recurrent Malignant Testicular Germ Cell Tumor; Recurrent Ovarian Germ Cell Tumor; Stage IV Extragonadal Non-Seminomatous Germ Cell Tumor; Stage IV Extragonadal Seminoma; Stage IV Ovarian Germ Cell Tumor	Indiana University	2013-02	PHASE2
NCT01703754	TERMINATED	Breast Cancer Nos Metastatic Recurrent	Alaunos Therapeutics	2013-04-04	PHASE2
NCT01340547	UNKNOWN	Advanced Solid Tumors	Alaunos Therapeutics	2011-06	PHASE1
NCT01168791	COMPLETED	Soft Tissue Sarcoma	Alaunos Therapeutics	2010-07	PHASE3
NCT01242072	UNKNOWN	Malignancy; Cancer; Non Small Cell Lung Cancer; Small Cell Lung Cancer; Testicular Cancer; Thymoma; Ovarian Cancer; Osteosarcoma	Alaunos Therapeutics	2010-11	PHASE1
NCT00718484	UNKNOWN	Soft Tissue Sarcoma	Alaunos Therapeutics	2008-08	PHASE2
NCT01340547	Unknown status	Advanced Solid Tumors	Alaunos Therapeutics	2011-06	Phase 1
NCT00607711	SUSPENDED	Advanced Cancer	Alaunos Therapeutics	2008-03	PHASE1

(data from https://clinicaltrials.gov, updated on 2013-05-21)

Check the Palifosfamide product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a direct DNA-alkylating agent, palifosfamide covalently binds to DNA bases to form interstrand DNA cross-links, which disrupts replication and transcription machinery to induce apoptotic cell death. This cytotoxic mechanism underlies its clinical investigation as an antineoplastic therapy for solid malignancies, including soft tissue sarcoma and extensive-stage small cell lung cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).