Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Calistoga Pharmaceuticals, Inc. |
---|---|
Information provided by: | Calistoga Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00710528 |
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 |
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 |
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
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Has relapsed or refractory disease as defined by the following:
Disease status requirement:
Exclusion Criteria:
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 |
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 |
CLL NHL AML Phosphatidylinositol 3-kinase |
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 |
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 |