Trials / Completed
CompletedNCT00710528
Dose Escalation Study of CAL-101 in Select Relapsed or Refractory Hematologic Malignancies
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 192 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Lymphoma, Non-Hodgkin (NHL)
- Acute Myeloid Leukemia (AML)
- Multiple Myeloma (MM)
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2011-12-01
- Completion
- 2012-08-01
- First posted
- 2008-07-04
- Last updated
- 2012-08-31
Locations
9 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00710528. Inclusion in this directory is not an endorsement.