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 Status

Closed to Enrollment

Study Description

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.

The study drug should be taken twice a day. You should take the morning dose with water on an empty stomach; food can be consumed at least an hour after dosing. The evening dose should be taken with water approximately 12 hours after the morning dose and at least 2 hours after a meal.

Each patient will be assessed for clinical response after completing 1 cycle of 28 days of treatment. Treatment may continue for up to a total of 6 cycles.

Disease Status and/or Stage

Relapsed or Refractory Hematological Malignancies

Sponsor

Calistoga Pharmaceuticals

Key Eligibility

  • Chronic Lymphocytic Leukemia (CLL) patients who are refractory to or relapsed after at least 2 prior therapies, including Fludarabine, alone or in combination
  • B cell non-Hodgkin's Lymphoma (NHL) patients 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
  • Acute Myeloid Leukemia (AML) patients refractory to or relapsed after at least 2 prior chemotherapy regimens
  • Multiple Myeloma (MM) patients 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
  • Patients must be symptomatic
  • Additional eligibility criteria to be discussed when you contact the study team

Principal Investigator

Richard Furman, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
roh2026@med.cornell.edu

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