Ongoing Studies

• Celator Pharmaceuticals (CPX-351)
• Acetylon Pharmaceuticals (ACY-1215)
• Curis (CUDC-907)
• Celgene Avilomics Research (CC-292)
• Shape Pharmaceuticals (SHP-141)
• Johns Hopkins University/LLS (PD0332991)
• University of Florida/LLS (OXi4503)
• University of Colorado/LLS (Cyclosporin A/Dasatinib)
• University Health Network/LLS (Ciclopirox)

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.

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

Visit the Curis website for additional information.

Celgene Avilomics Research, Inc. (formerly Avila Therapeutics, Inc.)

Phase 1b, Escalating Dose Stidy of AVL-292, a Bruton's Tyrosine Kinase (Btk) Inhibitor, as Monotherapy in Subjects with Relapsed and/or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia

The purpose of this study is to evaluate the safety and tolerability of AVL-292 as monotherapy in subjects with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).

ClinicalTrials.gov identifier: NCT01351935

For more information contact:
Kathyrn Stiede
Sr. Director, Clinical Operations
(781) 654-7686
kstiede@celgene.com

Visit the Celgene 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 Denver and The Leukemia & Lymphoma Society

Exploiting Synergy in Chronic Myelogenous Leukemia: A Phase Ib Evaluation of Dasatinib Plus Cyclosporine in Patients With Ph Leukemia Refractory to or Intolerant of Imatinib Mesylate (ESCAPE1b)

This study is intended to define the safety and tolerability of cyclosporine A in combination with dasatinib in adults with Bcr-Abl chronic myelogenous leukemia (CML) in chronic phase who have a sub-optimal outcome to front-line therapy with imatinib, either subjectively or objectively, or when used in patients with accelerated phase CML prior to definitive therapy with allogeneic hematopoietic stem cell transplantation.

Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Cyclosporine may help dasatinib work better by making cancer cells more sensitive to the drug. Giving dasatinib together with cyclosporine may be an effective treatment for chronic myelogenous leukemia.

ClinicalTrials.gov identifier: NCT01426334

For more information contact: 
Clinical Trials Office - University of Colorado Cancer Center
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, CO, 80045
(720) 848-0650

Visit the University of Colorado Denver website for additional information.

Phase I Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients with Relapsed or Refractory Hematologic Malignancy

This is an open-label, single arm study. Approximately up to 30 patients will be enrolled. Patients will receive oral ciclopirox olamine (aqueous suspension), initial starting dose of 5 mg/m2/day administered as a single dose daily for 5 days. Dose escalation will continue until establishment of the maximum tolerated dose (MTD) has been met.

Patients who have demonstrated response to treatment, up to six total cycles of treatment may be administered. If additional cycles are warranted, ciclopirox olamine will be given at the same dose and frequency as the patient initially received.

Princess Margaret Hospital (Toronto, Ontario, Canada) and Vancouver General Hospital (Vancouver, British Columbia, Canada) are sites for recruitment.

ClinicalTrials.gov identifier: NCT00990587

For more information contact:
Margaret Molnar
Princess Margaret Hospital
Margaret.Molnar@uhn.on.ca

Visit the University Health Network website for additional information.