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Phase I Dose Finding and Proof-of-concept Study of Panobinostat With Standard Dose Cytarabine and Daunorubicin for Untreated Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

NCT01463046 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2019-04-22

No results posted yet for this study

Summary

The purpose of this study is to see if Panobinostat is safe to give to patients and to determine the best dose to give in combination with standard cytarabine and daunorubicin chemotherapy.

Conditions

Interventions

DRUG

Panobinostat

Induction - 20-60 mg (1-3 20 mg capsules) PO on days 1,3,5 and 8 Second induction - 20-60 mg (1-3 20 mg capsules) PO days 1,3 and 5 Consolidation - 20-60 mg (1-3 20 mg capsules) PO on days 1,3,5 and 8

DRUG

Cytarabine

Induction - 100 mg/m2 continuous IV daily for 7 doses on day 3-9. Second induction - 100 mg/m2 continuous IV daily for 7 doses on day 3-7. Dosing for consolidation - 100 mg/m2 continuous IV daily for 7 doses on day 3-9.

DRUG

Daunorubicin

Induction - 60 mg/m2 IV over 15-30 minutes daily for 3 doses on day 3-5. Second induction - 60 mg/m2 IV over 15-30 minutes daily for 2 doses on day 3 and 4. Dosing for consolidation - 60 mg/m2 IV over 15-30 minutes daily for 3 doses on day 3-5.

Sponsors & Collaborators

Principal Investigators

  • Charalambos Andreadis, M.D. · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-11-14
Completion
2018-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01463046 on ClinicalTrials.gov