Dose Escalation Study of CAL-101 in Select Relapsed or Refractory Hematologic Malignancies
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ClinicalTrials.gov Identifier: NCT00710528 |
Recruitment Status :
Completed
First Posted : July 4, 2008
Last Update Posted : August 31, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Lymphocytic Leukemia (CLL) Lymphoma, Non-Hodgkin (NHL) Acute Myeloid Leukemia (AML) Multiple Myeloma (MM) | Drug: CAL-101 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 192 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: one arm |
Drug: CAL-101
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 |
- To evaluate the safety of CAL-101 and determine the dose limiting toxicity in patients with hematologic malignancies. [ Time Frame: 28 days ]
- To evaluate the pharmacokinetic parameters, pharmacodynamic effects and clinical response rate following CAL-101 treatment in patients with hematologic malignancies. [ Time Frame: 28 Days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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).
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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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710528
United States, California | |
Stanford Cancer Center | |
Palo Alto, California, United States, 94304-5548 | |
United States, Maryland | |
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins | |
Baltimore, Maryland, United States, 21231 | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
Weill Medical College of Cornell | |
New York, New York, United States, 10021 | |
United States, Ohio | |
The Ohio State University Medical Center | |
Columbus, Ohio, United States, 43210 | |
United States, Oregon | |
Oregon Health and Science University | |
Portland, Oregon, United States, 97239-3098 | |
United States, Tennessee | |
Sarah Cannon Research Institute | |
Nashville, Tennessee, United States, 37203 | |
United States, Wisconsin | |
University of Wisconsin | |
Madison, Wisconsin, United States, 53792-5156 |
Responsible Party: | Langdon Miller, M.D., VP Clinical Research, Onoclogy, Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00710528 |
Other Study ID Numbers: |
101-02 |
First Posted: | July 4, 2008 Key Record Dates |
Last Update Posted: | August 31, 2012 |
Last Verified: | August 2012 |
CLL NHL AML MM Phosphatidylinositol 3-kinase |
Idelalisib Leukemia Leukemia, Myeloid, Acute Multiple Myeloma Leukemia, Lymphocytic, Chronic, B-Cell Hematologic Neoplasms Lymphoma, Non-Hodgkin Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Leukemia, Myeloid Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias |
Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Leukemia, Lymphoid Lymphatic Diseases Leukemia, B-Cell Neoplasms by Site Lymphoma Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |