Dose Escalation Study of CAL-101 in Select Relapsed or Refractory Hematologic Malignancies
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
1 other identifier
interventional
192
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2008
Longer than P75 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 1, 2008
CompletedFirst Posted
Study publicly available on registry
July 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedAugust 31, 2012
August 1, 2012
3.5 years
July 1, 2008
August 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety of CAL-101 and determine the dose limiting toxicity in patients with hematologic malignancies.
28 days
Secondary Outcomes (1)
To evaluate the pharmacokinetic parameters, pharmacodynamic effects and clinical response rate following CAL-101 treatment in patients with hematologic malignancies.
28 Days
Study Arms (1)
one arm
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- Age \> or = 18.
- Has relapsed or refractory disease as defined by the following:
- CLL - refractory to or relapsed after at least 2 prior therapies, including fludarabine, alone or in combination. Patients should not be eligible for transplantation (patients who are candidates for transplantation and have declined transplantation are eligible for this study).
- B-cell NHL - refractory to or relapsed after at least 1 prior chemotherapy regimen and having received rituximab as a single agent or in combination with other therapies.
- AML - refractory to or relapsed after at least 1 cycle of induction chemotherapy. Patients over the age of 70 who are not appropriate candidates for chemotherapy are eligible for this study.
- MM - refractory to or relapsed after at least 2 prior chemotherapy regimens, including bortezomib and thalidomide or lenalidomide (except if the drug is contraindicated in a patient then this requirement is waived).
- Disease status requirement:
- For CLL patients, symptomatic disease that mandate treatment.
- For B-cell NHL patients, has measurable disease by CT scan.
- For AML patients, has \> 10% blasts in the bone marrow for refractory or relapsed disease and \> 20% blasts in the bone marrow if no prior chemotherapy.
- For MM patients, has measurable disease defined by at least 1 of the following 3 measurements: serum M-protein \> or = to 1 g/dL, urine M-protein \> or = to 200 mg/24 h, or serum free light chain (FLC) assay with involved FLC level \> or = to 10 mg/dL provided serum FLC ratio is abnormal.
- WHO performance status of ≤ 2.
- For men and women of child-bearing potential, willing to use adequate contraception (i.e., latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study.
- Is able to provide written informed consent.
You may not qualify if:
- Had radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment with an investigational product within 4-weeks prior to screening.
- For CLL or NHL patients, had treatment with a short course of corticosteroids for symptom relief within 1-week prior to screening.
- Had alemtuzumab therapy within 12-weeks prior to screening.
- For AML patients, had treatment with hydroxyurea within 1-week prior to screening.
- Is pregnant or nursing.
- Has significant, ongoing co-morbid conditions which would preclude safe delivery of the study drug.
- Has had a transplant with current active graft-versus-host-disease.
- Has known active central nervous system involvement of the malignancy.
- Has active, serious infection requiring systemic therapy. Patients may receive prophylactic antibiotics and antiviral therapy at the discretion of the treating physician.
- Has significant renal or liver dysfunction.
- Has severe thrombocytopenia requiring platelet transfusion support, unless the diagnosis is AML.
- Has a positive test for human immunodeficiency virus (HIV) antibodies.
- Has active hepatitis B or C. Patients with serologic evidence of prior exposure are eligible.
- Has poorly controlled diabetes mellitus.
- Has taken a medication that is a potent inhibitor or inducer of cytochrome P450 3A4 within 1-week prior to screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (9)
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
Portland, Oregon, 97239-3098, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
University of Wisconsin
Madison, Wisconsin, 53792-5156, United States
Related Publications (4)
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.
PMID: 24615778DERIVEDBrown 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.
PMID: 24615777DERIVEDFlinn 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.
PMID: 24615776DERIVEDStevenson 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.
PMID: 21816833DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 1, 2008
First Posted
July 4, 2008
Study Start
June 1, 2008
Primary Completion
December 1, 2011
Study Completion
August 1, 2012
Last Updated
August 31, 2012
Record last verified: 2012-08