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A Trial of Oral 5-azacitidine in Combination With Romidepsin in Advanced Solid Tumors, With an Expansion Cohort in Virally Mediated Cancers and Liposarcoma

NCT01537744 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-03-24

No results posted yet for this study

Summary

The purpose of this study is to determine whether 5-azacitidine in combination with romidepsin cancer are effective in the treatment of advanced solid tumors.

Conditions

Interventions

DRUG

oral 5-azacitidine in combination with romidepsin

DOSING REGIMEN(S): Table 1: Dose Escalation Schedule Dose Level Dose and Schedule a, c 5-Azacitidine (PO) Romidepsin (IV) Level -1b 100mg daily days 1-14 8mg/m2 days 8 and 15 Level 1 200mg daily days 1-14 8mg/m2 days 8 and 15 Level 2 300mg daily days 1-14 8mg/m2 days 8 and 15 Level 3 300mg daily days 1-21 8mg/m2 days 8 and 15 Level 4d MTD 8mg/m2 days 8, 15, and 22 1. Each cycle will last 28 days. 2. Subjects will be enrolled in Level -1 if the MTD is reached in the subjects enrolled in Level 1. 3. On days when both agents are administered, oral 5-azacitidine should be administered at the start of the romidepsin infusion. 4. Level 4 is optional and decisions whether to initiate this level will be based on discussions between the study investigator and Celgene.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Nilofer Azad, MD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2016-03-31
Completion
2016-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01537744 on ClinicalTrials.gov