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Amrubicin + Cyclophosphamide in Advanced Solid Organ Malignancies

NCT00890955 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-12-23

No results posted yet for this study

Summary

Amrubicin has shown single-agent activity in lung cancer. The combination of cyclophosphamide and anthracyclines has been studied and concluded that the combination was tolerable, could be given safely, and therapeutically useful.

This Phase I study will evaluate the combination of cyclophosphamide with amrubicin in relapsed solid tumors and will define the MTD of the combination in a US population.

Conditions

Interventions

DRUG

Amrubicin

* Dose Level -1: 20mg/m2 * Dose Level 1: 25mg/m2 * Dose Level 2: 30mg/m2 * Dose Level 3: 35mg/m2 * Dose Level 4: 40mg/m2 Amrubicin will be given as a slow IV push or infusion over approximately 5 minutes once daily for 3 consecutive days starting on day 1 of each 21 day cycle.

DRUG

Cyclophosphamide

Cyclophosphamide will be given at a fixed dose as 500mg/m2 IV infusion over 30-60 minutes on day 1 of each 21 day cycle (following amrubicin).

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Hoosier Cancer Research Network

    collaborator OTHER

  • Lawrence Einhorn

    lead OTHER

Principal Investigators

  • Lawrence Einhorn, M.D. · Hoosier Cancer Research Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

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Drugs
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 NCT00890955 on ClinicalTrials.gov