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Dose Escalation Study of CAL-101 in Select Relapsed or Refractory Hematologic Malignancies
This study is currently recruiting participants.
Verified by Calistoga Pharmaceuticals, Inc., March 2009
First Received: July 1, 2008   Last Updated: March 23, 2009   History of Changes
Sponsored by: Calistoga Pharmaceuticals, Inc.
Information provided by: Calistoga Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00710528
  Purpose

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.


Condition Intervention Phase
Chronic Lymphocytic Leukemia (CLL)
Lymphoma, Non-Hodgkin (NHL)
Acute Myeloid Leukemia (AML)
Drug: CAL-101
Phase I

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: 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

Further study details as provided by Calistoga Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • To evaluate the safety of CAL-101 and determine the dose limiting toxicity in patients with hematologic malignancies. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the pharmacokinetic parameters, pharmacodynamic effects and clinical response rate following CAL-101 treatment in patients with hematologic malignancies. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
one arm: Experimental Drug: CAL-101
CAL-101 - 50, 100, 200, 375 mg capsules BID for 28 days

Detailed Description:

A Phase 1, sequential dose escalation followed by cohort expansion study of CAL-101, an oral inhibitor of PI3K delta, in patients with relapsed or refractory CLL, select B-cell NHL and AML.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > or = 18.
  2. 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.
  3. 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.
  4. WHO performance status of ≤ 2.
  5. 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.
  6. Is able to provide written informed consent.

Exclusion Criteria:

  1. Had radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment with an investigational product within 4-weeks prior to screening.
  2. For CLL or NHL patients, had treatment with a short course of corticosteroids for symptom relief within 1-week prior to screening.
  3. Had alemtuzumab therapy within 12-weeks prior to screening.
  4. For AML patients, had treatment with hydroxyurea within 1-week prior to screening.
  5. Is pregnant or nursing.
  6. Has significant, ongoing co-morbid conditions which would preclude safe delivery of the study drug.
  7. Has had a transplant with current active graft-versus-host-disease.
  8. Has known active central nervous system involvement of the malignancy.
  9. Has active, serious infection requiring systemic therapy. Patients may receive prophylactic antibiotics and antiviral therapy at the discretion of the treating physician.
  10. Has significant renal or liver dysfunction.
  11. Has severe thrombocytopenia requiring platelet transfusion support, unless the diagnosis is AML.
  12. Has a positive test for human immunodeficiency virus (HIV) antibodies.
  13. Has active hepatitis B or C. Patients with serologic evidence of prior exposure are eligible.
  14. Has poorly controlled diabetes mellitus.
  15. Has taken a medication that is a potent inhibitor or inducer of cytochrome P450 3A4 within 1-week prior to screening.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710528

Locations
United States, California
Stanford Cancer Center Recruiting
Palo Alto, California, United States, 94304-5548
Contact: Dana Supan     650-725-8538     dsupan@stanford.edu    
Principal Investigator: Steven Coutre, MD            
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Michelle Burton, RN, BSN     813-979-3965     michelle.burton@moffitt.org    
Principal Investigator: Celeste Bello, M.D.            
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Katherine McIntyre     410-502-0824     kmcinty6@jhmi.edu    
Principal Investigator: B. Douglas Smith, MD            
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Shannon Kerivan, M.D.     617-632-4591     Shannon_Kerivan@dfci.harvard.edu    
Principal Investigator: Jennifer Brown, M.D.            
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Justina First     314-362-4206     jfirst@dom.wustl.edu    
Principal Investigator: Nina Wagner-Johnston, MD            
United States, New York
Weill Medical College of Cornell Recruiting
New York, New York, United States, 10021
Contact: Jennifer O'Loughlin     212-746-5269     jeo2008@med.cornell.edu    
Principal Investigator: Richard Furman, M.D.            
United States, Ohio
The Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Cheryl Kefauver     614-293-3321     cheryl.kefauver@osumc.edu    
Principal Investigator: Thomas Lin, M.D.            
United States, Tennessee
Sarah Cannon Cancer Center Recruiting
Nashville, Tennessee, United States, 37203
Contact: Matthew Pagni     615-329-7239     matthew.pagni@scresearch.net    
Principal Investigator: Ian Flinn, MD            
Sponsors and Collaborators
Calistoga Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Calistoga Pharmaceuticals, Inc. ( Albert Yu, M.D., Chief Medical Officer )
Study ID Numbers: 101-02
Study First Received: July 1, 2008
Last Updated: March 23, 2009
ClinicalTrials.gov Identifier: NCT00710528     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Calistoga Pharmaceuticals, Inc.:
CLL
NHL
AML
Phosphatidylinositol 3-kinase

Study placed in the following topic categories:
Leukemia, Lymphoid
Immunoproliferative Disorders
Hematologic Neoplasms
Hematologic Diseases
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Lymphatic Diseases
Chronic Lymphocytic Leukemia
Acute Myelocytic Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, Chronic
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:
Leukemia, Lymphoid
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Hematologic Neoplasms
Hematologic Diseases
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Lymphatic Diseases
Neoplasms
Neoplasms by Site
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009