A Phase 1 Sequential Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of CAL-101 in Patients With Select, Relapsed or Refractory Hematologic Malignancies
Sponsor study identifier
interventional
192
1 country
9
Study Start
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2011
Actual (reported)Study Completion
August 2012
Actual (reported)The purpose of this study is to determine the dose that can be safely given to see what effect it may have on your cancer and to determine how the drug is distributed in the body.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
July 1, 2008
Actual (reported)July 4, 2008
Actual (reported)December 2011
Actual (reported)August 2012
Actual (reported)To evaluate the safety of CAL-101 and determine the dose limiting toxicity in patients with hematologic malignancies.
28 days
To evaluate the pharmacokinetic parameters, pharmacodynamic effects and clinical response rate following CAL-101 treatment in patients with hematologic malignancies.
28 Days
CAL-101 50, 100, 150, 200, 350 mg capsules BID for 28 days CAL-101 150, 300 mg QD for 28 days CAL-101 150 mg BID 3 weeks on 1 week off for 28 days
Stanford Cancer Center
Palo Alto, California, 94304-5548, United States
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, 21231, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Weill Medical College of Cornell
New York, New York, 10021, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Oregon Health and Science University
Kahl BS, Spurgeon SE, Furman RR, Flinn IW, Coutre SE, Brown JR, Benson DM, Byrd JC, Peterman S, Cho Y, Yu A, Godfrey WR, Wagner-Johnston ND. A phase 1 study of the PI3Kdelta inhibitor idelalisib in patients with relapsed/refractory mantle cell lymphoma (MCL). Blood. 2014 May 29;123(22):3398-405. doi: 10.1182/blood-2013-11-537555. Epub 2014 Mar 10.
Brown JR, Byrd JC, Coutre SE, Benson DM, Flinn IW, Wagner-Johnston ND, Spurgeon SE, Kahl BS, Bello C, Webb HK, Johnson DM, Peterman S, Li D, Jahn TM, Lannutti BJ, Ulrich RG, Yu AS, Miller LL, Furman RR. Idelalisib, an inhibitor of phosphatidylinositol 3-kinase p110delta, for relapsed/refractory chronic lymphocytic leukemia. Blood. 2014 May 29;123(22):3390-7. doi: 10.1182/blood-2013-11-535047. Epub 2014 Mar 10.
192 participants (actual enrollment reported by the registry).
First Submitted
July 1, 2008
First Posted
July 4, 2008
Study Start
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
Study of Intravenously Administered SNS-032 in Patients With Advanced B-lymphoid Malignancies
Contact the study team to confirm eligibility.
Portland, Oregon, 97239-3098, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
University of Wisconsin
Madison, Wisconsin, 53792-5156, United States
Flinn IW, Kahl BS, Leonard JP, Furman RR, Brown JR, Byrd JC, Wagner-Johnston ND, Coutre SE, Benson DM, Peterman S, Cho Y, Webb HK, Johnson DM, Yu AS, Ulrich RG, Godfrey WR, Miller LL, Spurgeon SE. Idelalisib, a selective inhibitor of phosphatidylinositol 3-kinase-delta, as therapy for previously treated indolent non-Hodgkin lymphoma. Blood. 2014 May 29;123(22):3406-13. doi: 10.1182/blood-2013-11-538546. Epub 2014 Mar 10.
Stevenson FK, Krysov S, Davies AJ, Steele AJ, Packham G. B-cell receptor signaling in chronic lymphocytic leukemia. Blood. 2011 Oct 20;118(16):4313-20. doi: 10.1182/blood-2011-06-338855. Epub 2011 Aug 3.
Primary Completion
December 2011
Actual (reported)Study Completion
August 2012
Actual (reported)Last Updated
August 31, 2012
Record last verified: 2012-08
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Source: ClinicalTrials.gov.
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