Drugs / Palifosfamide
Palifosfamide
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00421135 | Feb 2006 → Oct 2007 | cancer of unknown primary site | Alaunos Therapeutics | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00439686 | Feb 2006 → Jan 2008 | sarcoma | Alaunos Therapeutics | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT01703754 | Apr 2013 → Aug 2014 | breast carcinoma | Alaunos Therapeutics | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01808534 | Feb 2013 → Nov 2014 | adult central nervous system germ cell tumor, adult teratoma, extragonadal nonseminomatous germ cell tumor, extragonadal seminoma +2 | Indiana University | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 28
| Date | Issuer | Release |
|---|---|---|
| 2013-03-26 | Alaunos Therapeutics | Results ZIOPHARM Terminates Development of Palifosfamide in Metastatic Soft Tissue Sarcoma alaunos.com ↗
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced today that its Phase 3 trial of palifosfamide (ZIO-201) for the treatment of metastatic soft tissue sarcoma in the first-line setting (PICASSO 3) did not meet its primary endpoint of progression-free survival (PFS). |
| 2012-08-01 | Alaunos Therapeutics | Results Independent Data Monitoring Committee of ZIOPHARM's Phase 3 Study of Palifosfamide in Metastatic Soft Tissue Sarcoma Recommends Continuation of Trial Following Planned Interim Futility Analysis alaunos.com ↗
Independent Data Monitoring Committee of ZIOPHARM's Phase 3 Study of Palifosfamide in Metastatic Soft Tissue Sarcoma Recommends Continuation of Trial Following Planned Interim Futility Analysis |
| 2012-04-03 | Alaunos Therapeutics | Results ZIOPHARM Oncology Presents Compelling Data Showing Palifosfamide Activity in Breast Cancer Models at AACR Meeting alaunos.com ↗
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company with small molecule and synthetic biology approaches to new cancer therapies, announced today the presentation of two preclinical studies demonstrating compelling results for palifosfamide in breast cancer. |
| 2012-02-13 | Alaunos Therapeutics | Results ZIOPHARM Oncology Reports Positive Preliminary Palifosfamide Overall Survival Data From Randomized Phase 2 Study in Soft Tissue Sarcoma alaunos.com ↗
This well-controlled trial is demonstrating longer than expected survival in a difficult to treat population. |
| 2012-02-06 | Alaunos Therapeutics | Regulatory ZIOPHARM Announces FDA Acceptance of IND for Oral Palifosfamide alaunos.com ↗
the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for the oral dosing of palifosfamide |
| 2011-11-14 | Alaunos Therapeutics | Results ZIOPHARM Oncology Announces Promising Data from Phase 1b Study of Palifosfamide in Small Cell Lung and Other Cancers at AACR-NCI-EORTC Meeting alaunos.com ↗
ZIOPHARM Oncology Announces Promising Data from Phase 1b Study of Palifosfamide in Small Cell Lung and Other Cancers at AACR-NCI-EORTC Meeting |
| 2011-10-28 | Alaunos Therapeutics | Results ZIOPHARM Presents Promising Preclinical Pediatric Sarcoma Data with Oral and IV Palifosfamide at the 2011 CTOS/MSTS Meeting alaunos.com ↗
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a drug development company employing small molecule and synthetic biology approaches to cancer therapy, today announced the presentation of promising preclinical data with palifosfamide (Zymafos™ or ZIO-201) in a pediatric sarcoma model. |
| 2010-06-07 | Alaunos Therapeutics | Results ZIOPHARM Presents Positive Palifosfamide PICASSO Phase II Results in Oral Session at ASCO alaunos.com ↗ |
| 2010-05-21 | Alaunos Therapeutics | Results ZIOPHARM to Present Further Palifosfamide PICASSO Phase II Results in Oral Session at ASCO alaunos.com ↗
With this interim analysis of all randomized and eligible patients, the hazard ratio is 0.43 favoring palifosfamide + doxorubicin (two-sided Wilcoxon-Gehan p-value = 0.019). |
| 2009-11-06 | Alaunos Therapeutics | Results ZIOPHARM Presents Positive Palifosfamide Sarcoma Randomized Phase II Interim Data at Annual Meeting of the Connective Tissue Oncology Society alaunos.com ↗
With this analysis of all randomized and eligible patients, the hazard ratio is 0.63 favoring palifosfamide + doxorubicin (two-sided Wilcoxon-Gehan p-value = 0.026), statistically supporting that palifosfamide prolongs PFS by at least 50%. |
| 2009-10-14 | Alaunos Therapeutics | Results ZIOPHARM Announces Positive Palifosfamide Sarcoma Randomized Phase II Interim Data: Trial Enrollment Stopped Early alaunos.com ↗
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today positive top line interim data from the multicenter randomized Phase II trial of palifosfamide (Zymafos TM , ZIO-201) treating patients with unresectable or metastatic soft tissue sarcoma. |
| 2009-05-31 | Alaunos Therapeutics | Results ZIOPHARM Presents Positive Data from Phase I Study of Palifosfamide in Combination with Doxorubicin at ASCO alaunos.com ↗
Of 12 evaluable patients, there were 3 partial responses. |
| 2008-11-17 | Alaunos Therapeutics | Results ZIOPHARM Oncology Presents Positive Data from Studies of Palifosfamide alaunos.com ↗
Of 12 evaluable patients, 3 had partial responses. |
| 2008-10-15 | Alaunos Therapeutics | Regulatory ZIOPHARM Receives Orphan Medicinal Product Designation for Palifosfamide (ZIO-201) in the Treatment of Soft Tissue Sarcoma alaunos.com ↗
ZIOPHARM Receives Orphan Medicinal Product Designation for Palifosfamide (ZIO-201) in the Treatment of Soft Tissue Sarcoma |
| 2008-05-09 | Alaunos Therapeutics | Regulatory ZIOPHARM Receives FDA Orphan Drug Designation for Palifosfamide (ZIO-201) in the Treatment of Soft Tissue Sarcoma alaunos.com ↗
ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP), announced today that the United States Food & Drug Administration (FDA) has granted Orphan Drug Designation to palifosfamide in the treatment of Soft Tissue Sarcoma (STS). |
| 2007-11-05 | Alaunos Therapeutics | Results ZIOPHARM Presents Positive Phase II Data for ZIO-201 in Soft Tissue and Bone Sarcomas at Connective Tissue Oncology Society (CTOS) Annual Meeting alaunos.com ↗
Of 44 evaluable patients, 48% had stable disease or better with a median progression free survival of 10 weeks. |
| 2007-09-25 | Alaunos Therapeutics | Results Positive ZIO-201 Interim Phase II Sarcoma Data Presented at European College of Clinical Oncology Annual (ECCO) Meeting alaunos.com ↗
In 14 of the 31 patients (45%), there is a clinically beneficial response including one partial response (PR), four minor responses (MR), and nine with stable disease (SD). |
| 2007-07-09 | Alaunos Therapeutics | Results Positive ZIO-201 Interim Phase II Sarcoma Data Presented at European Society for Medical Oncology alaunos.com ↗
Of these 10 heavily pretreated patients (median 4 prior regimens), 1 has a partial response (21 weeks and ongoing) and 4 have stable disease. |
| 2007-04-16 | Alaunos Therapeutics | Results ZIOPHARM Presents Data on Orally Active ZIO-201 at AACR alaunos.com ↗
Data presented demonstrated oral availability of ZIO-201 and activity in a variety of cancer models, including those with ifosfamide (IFOS) and cyclophosphamide resistant tumors. |
| 2007-03-23 | Alaunos Therapeutics | Results ZIOPHARM Presents ZIO-201 Lymphoma Data at ISH alaunos.com ↗
Data presented at ISH yesterday highlighted that ZIO-201 was 10 to 30 fold more active than IFOS in most in vitro and in vivo models of lymphoma. |
| 2006-11-03 | Alaunos Therapeutics | Results ZIOPHARM Presents ZIO-201 Phase I Data at CTOS alaunos.com ↗
The results demonstrated evidence of clinical activity in sarcoma (2/11 patients including at least one who had failed IFOS therapy) and mesothelioma (1 patient with extended stable disease). |
| 2006-11-02 | Alaunos Therapeutics | Results ZIO-201 Preclinical Data Demonstrate Effectiveness in Pediatric Cancers alaunos.com ↗
ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP) and colleagues today presented new data on the effect of ZIO-201 on several human pediatric sarcoma models (Ewing sarcoma, rhabdomyosarcoma, synovial sarcoma and osteosarcoma) demonstrating potent anti-cancer activity. |
| 2006-06-05 | Alaunos Therapeutics | Results ZIOPHARM Presents Preliminary ZIO-201 Clinical Results at ASCO alaunos.com ↗
These data support the Company's premise that certain adverse events associated with ifosfamide, an approved cancer drug extensively used in the United States and Europe, can be avoided with ZIO-201, the active metabolite of ifosfamide. |
| 2006-04-03 | Alaunos Therapeutics | Results ZIOPHARM Presents ZIO-201/202/203 Preclinical Data at AACR alaunos.com ↗
These data show ZIO-201 is active against cisplatin (CDDP)-resistant leukemia cells. |
| 2006-02-21 | Alaunos Therapeutics | Results ZIOPHARM Presents ZIO-201 Preclinical Kidney Toxicity Data at Bone Marrow Transplant Meetings alaunos.com ↗
Dr. Taub's study indicated that chloroacetaldehyde and acrolein, but not ZIO-201, killed the proximal tubule cells. |
| 2006-02-17 | Alaunos Therapeutics | Results ZIOPHARM Presents ZIO-201 Preclinical Data at Bone Marrow Transplant Meetings alaunos.com ↗
ZIOPHARM Oncology, Inc. (OTC BB: ZIOP) presented preclinical data today at the 2006 Bone Marrow Transplant Meetings in Honolulu demonstrating that ZIO-201, the Company's proprietary alkylating agent, may have a role in conditioning for bone marrow transplants. |
| 2005-11-21 | Alaunos Therapeutics | Results ZIOPHARM Oncology Announces ZIO-201 ASH Abstract Publication alaunos.com ↗
In abstract 4727 titled "Isophosphoramide Mustard-lysine (ZIO-201): Active Moiety of Ifosfamide (IFOS) without Kidney Toxicity," by Mary Taub and coworkers at the State University of New York at Buffalo, data regarding effects on rabbit kidney proximal tubule cells report ZIO-201 avoids kidney damage caused by metabolites of ifosfamide, the pro-drug of ZIO-201. |
| 2005-04-19 | Alaunos Therapeutics | Results ZIOPHARM Presents ZIO-201 Preclinical Data At AACR alaunos.com ↗
Data presented today include L-IPM activity in cyclophosphamide- and ifosfamide-resistant cancers. |
All press releases naming this drug 47 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | palifosfamide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01808534 ↗ |
| Known as | IPM | “A Protocol for the Safety and Tolerance of Intravenous Isophosphoramide Mustard (IPM) in Patients With Advanced Cancer” NCT00421135 ↗ |
| Known as | Isophosphoramide Mustard | “A Protocol for the Safety and Tolerance of Intravenous Isophosphoramide Mustard (IPM) in Patients With Advanced Cancer” NCT00421135 ↗ |
| Known as | palifosfamide-lysine | “Palifosfamide-lysine (ZIO-201) was administered by intravenous infusion on Days 1, 2, and 3 of each 21-day cycle.” NCT00439686 ↗ |
| Known as | ZIO-201 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00421135 ↗ |
| Modality | Small molecule | “Small molecule chemotherapy, IV administration” NCT01703754 ↗ |
| Route | Intravenous | “Intravenous Isophosphoramide Mustard (IPM)” NCT00421135 ↗ |