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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia (CLL), Lymphoma, Non-Hodgkin (NHL), Acute Myeloid Leukemia (AML), Multiple Myeloma (MM)

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Trial Information

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


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.


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.

- 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).

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.

- 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.

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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

28 days

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

101-02

NCT ID:

NCT00710528

Start Date:

June 2008

Completion Date:

August 2012

Related Keywords:

  • Chronic Lymphocytic Leukemia (CLL)
  • Lymphoma, Non-Hodgkin (NHL)
  • Acute Myeloid Leukemia (AML)
  • Multiple Myeloma (MM)
  • CLL
  • NHL
  • AML
  • MM
  • Phosphatidylinositol 3-kinase
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Stanford Cancer CenterStanford, California  94305-5824
Oregon Health and Science UniversityPortland, Oregon  97201
University of WisconsinMadison,, Wisconsin  53792-5666
The Ohio State University Medical CenterColumbus, Ohio  43210
Sarah Cannon Research InstituteNashville, Tennessee  37203
The Sidney Kimmel Comprehensive Cancer Center at John HopkinsBaltimore, Maryland  21231
Weill Medical College of CornellNew York, New York  10021