TAP Pipeline
Ongoing Studies
- Celator Pharmaceuticals (CPX-351)
- Acetylon Pharmaceuticals (ACY-1215)
- Curis (CUDC-907)
- Shape Pharmaceuticals (SHP-141)
- Johns Hopkins University/LLS (PD0332991)
- University of Florida/LLS (OXi4503)
- University of Colorado/LLS (PF-04449913)
Studies Starting Soon
- None
Celator Pharmaceuticals
Phase 3, Multicenter, Randomized Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients 60-75 Years of Age with Untreated High Risk Secondary AML
The primary purpose of this study is to confirm the efficacy of CPX-351 compared to 7 3 (Cytarabine and Daunorubicin) as first line therapy in elderly patients (60-75 yrs) with high risk secondary Acute Myeloid Leukemia.
ClinicalTrials.gov identifier: NCT01696084
For more information contact:
Arthur C Louie, MD
(609) 243-0123
alouie@celatorpharma.com
Kim H Paulsen
(609) 243-6235
kpaulsen@celatorpharma.com
Visit the Celator Pharmaceuticals website for additional information.
Acetylon Pharmaceuticals, Inc.
Arthur C Louie, MD
(609) 243-0123
alouie@celatorpharma.com
Kim H Paulsen
(609) 243-6235
kpaulsen@celatorpharma.com
Visit the Celator Pharmaceuticals website for additional information.
A Phase 1/2, Open-Label, Multicenter Study of ACY-1215 Administered Orally as Monotherapy and in Combination with Bortezomib and Dexamethasone for the Treatment of Relapsed or Relapsed/Refractory Multiple Myeloma
Phase 1(a &b): To evaluate the side effects and determine the best dose or oral ACY-1215 as monotherapy, and also in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.
Phase 2a: To determine the objective response rate of oral ACY-1215 in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.
ClinicalTrials.gov identifier: NCT01323751
For more information contact:
Gina Leone
Acetylon Pharmaceuticals, Inc.
(617) 638-0475
gleone@acetylon.com
Visit the Acetylon Pharmaceuticals website for additional information.
Curis, Inc.
Phase I Open Label, Multi-center, Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, a PI3K and HDAC Inhibitor, in Subjects With Refractory or Relapsed Lymphoma or Multiple Myeloma
The purpose of this phase I, open-label, dose-escalation study of CUDC-907 in patients with refractory or relapsed lymphoma or multiple myeloma is to assess the safety, including the maximum tolerated dose, the pharmacokinetics, and the anti-cancer activity of CUDC-907. CUDC-907 is a multi-targeted agent designed to inhibit phosphoinositide 3-kinase (PI3K) and histone deacetylase (HDAC).
ClinicalTrials.gov identifier: NCT01742988
For more information contact the recruiting sites:
Heather Pedigo
Sarah Cannon Research Institute
Nashville, TN, 37203
(615) 329-7432
Heather.Pedigo@scresearch.net
Amy Copeland, RN, MSN, CNS
Memorial Sloan-Kettering Cancer Center
New York, NY 10065
(212) 639-6104
copelana@mskcc.org
Visit the Curis website for additional information.
Shape Pharmaceuticals
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase 1b Study to Assess the Safety, Pharmacodynamics and Pharmacokinetics of SHP-141, a Topical Histone Deacetylase Inhibitor, Administered up to 28 Days to Patients with Stage IA, IB or IIA cutaneous T-cell lymphoma
The purpose of this study is to investigate the safety and tolerability of topical SHP141 applied directly to skin lesions in patients with Stage IA, IB, or IIA cutaneous T-cell lymphoma. This study will also investigate the effect of SHP141 on skin lesions in patients with Stage IA, IB, or IIA CTCL.
ClinicalTrials.gov identifier: NCT01433731
For more information contact the recruiting sites:
Nazila Barahmani, MD
Northwestern University
Dept of Dermatology
Chicago, IL, 60611
(312) 695-6786
Amanda Maggiotto
Cleveland Clinic
Cleveland, OH, 44195
(866) 223-8100
Katie Turner
Stanford University
Stanford, CA, 94305
(650) 725-1202
Carol Wilson
MD Anderson Cancer Center
Houston, TX, 77030
(713) 563-4655
Visit the Shape Pharmaceuticals website for additional information.
Johns Hopkins University and The Leukemia & Lymphoma Society
A Phase I and Pharmacodynamic Trial of Timed Sequential Administration of the Cyclin Dependent Kinase 4/6 Inhibitor PD 0332991 Followed by Cytarabine plus Mitoxantrone for Adults with Relapsed and Refractory Acute Leukemias and High-Risk Myelodysplasias
This study's primary objectives are to determine the feasibility, tolerability, and toxicities of administering the selective CDK 4/6 inhibitor PD 0332991 prior to the combination of ara-C and Mitoxantrone for adults with relapsed and refractory acute leukemias and high risk myelodysplasias (MDS), including primary refractory disease. Other primary objectives include to determine the direct cytotoxic effects of single agent PD 0332991 on malignant blasts, the maximal tolerated dose (MTD) of PD 0332991 in timed sequential combination with ara-C and Mitoxantrone and if the timed sequential combination of PD 0332991 with ara-C and mitoxantrone can induce clinical responses in adults with relapsed or refractory acute leukemias and high-risk MDS.
Secondary objectives of this study are to determine the ability of PD 0332991 to directly induce apoptosis in malignant cell populations in vivo and to obtain pharmacodynamic data regarding the ability of PD 0332991 to arrest malignant cells in the G1 phase of cell cycle, followed by synchronized release of those cells into S phase upon discontinuation of PD 0332991 and resultant enhanced ara-C cytotoxicity.
ClinicalTrials.gov identifier: NCT01701375
For more information contact:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, MD, 21287
Judith Karp, MD
(410) 502-7726
jkarp2@jhmi.edu
Jackie Greer, RN
(410) 614-1329
jgreer6@jhmi.edu
Visit the Johns Hopkins University website for additional information.
University of Florida and The Leukemia & Lymphoma Society
A Phase I Clinical Trial of OXi4503 for Relapsed and Refractory Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndromes (MDS)
This study is intended to determine the safety and maximum tolerated dose of a drug, OXi4503 (combretastatin A1 diphosphate, CA1P, OXiGENE), in patients with relapsed and refractory AML and MDS.
ClinicalTrials.gov identifier: NCT01085656
For more information contact:
Leslie Pettiford, RN, Study Coordinator
University of Florida Shands Cancer Center
(352) 273-6839
lpettiford@ufl.edu
Visit the University of Florida website for additional information.
University of Colorado and The Leukemia & Lymphoma Society
A Phase 2 Study of PF-04449913 for the Treatment of Acute Leukemia Patients With High Risk of Post-Allogeneic Stem Cell Transplantation Relapse
Disease relapse is the most common cause of death after allogeneic stem cell transplantation for acute leukemia. Patients at high risk for relapse may benefit from a novel, biologically rational therapeutic intervention to prevent this outcome. PF-04449913 is a small molecule inhibitor of the hedgehog (Hh) pathway that inhibits the protein Smoothened (SMO). Aberrant Hh signaling may contribute to the survival and expansion of the leukemia stem cell, and inhibiting the Hh pathway can eliminate these cells. Therefore, targeting Hh may be a logical intervention in the post-transplantation setting for those with high risk of relapse.
This is an open label, phase 2 study employing PF-04449913 in acute leukemia patients who received allogeneic stem cell transplantation and are at high risk of relapse. Patients will receive consecutive 28-day cycles of PF-04449913 at 100 mg/day, beginning on post-transplantation day 80 +/- 10 days, after their routine post-transplant bone marrow biopsy. Treatment will continue for up to one year or until they experience toxicity or disease relapse. Seventeen patients will be required for an 80% power to detect a 30% difference in one-year relapse free survival.
ClinicalTrials.gov identifier: NCT01841333
For more information contact:
Nicole Ayodeji
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
(720) 848-0701
Nikki.Ayodeji@ucdenver.edu
Visit the University of Colorado website for additional information.
