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

Gilead Sciences9 sites in 1 country192 target enrollmentJune 2008

ConditionsChronic Lymphocytic Leukemia (CLL)Lymphoma, Non-Hodgkin (NHL)Acute Myeloid Leukemia (AML)Multiple Myeloma (MM)

InterventionsCAL-101

DrugsCAL-101

Overview

Phase: Phase 1
Intervention: CAL-101
Conditions: Chronic Lymphocytic Leukemia (CLL)
Sponsor: Gilead Sciences
Enrollment: 192
Locations: 9
Primary Endpoint: To evaluate the safety of CAL-101 and determine the dose limiting toxicity in patients with hematologic malignancies.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

August 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Gilead Sciences

Eligibility Criteria

Inclusion Criteria

•Age \> or =
•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.

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.

Arms & Interventions

one arm

Intervention: CAL-101

Outcomes

Primary Outcomes

To evaluate the safety of CAL-101 and determine the dose limiting toxicity in patients with hematologic malignancies.

Time Frame: 28 days

Secondary Outcomes

To evaluate the pharmacokinetic parameters, pharmacodynamic effects and clinical response rate following CAL-101 treatment in patients with hematologic malignancies.(28 Days)