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Trial Of Cisplatin And KML-001 in Platinum Responsive Malignancies

NCT01110226 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-03-17

No results posted yet for this study

Summary

This is a Phase I Clinical Trial. Phase I studies are designed to determine the amount of investigational drugs that can be safely tolerated and to define the side effects that limit the dose. The drug administered in this study is KML-001. It is a highly soluble, orally available arsenic agent. It is currently being tested to determine its effects on telomerase activity.

In other words, the purpose of this research study is to find the highest dose of KML001, that can be given without causing severe side effects when it is combined with a standard, commercially available anti-cancer drug called cisplatin.

Conditions

  • Non-Small Cell Lung Cancer, Small Cell Lung Cancer
  • Platinum Responsive Malignancies

Interventions

DRUG

KML-001

KML001 will begin given to patients first. It should be taken by mouth immediately prior to cisplatin infusion. Patients will be treated in cohorts of three beginning at 15mg. The Dose will be increased until Maximum Tolerated Dose is established. KML001 will be administered daily for 14 days of a 21 day cycle. Patients will have one week off.

DRUG

Cisplatin

Cisplatin will be given to all patients at a dose of 75 mg/m2 on day 1 of every 21 day cycle over 30 to 90 minutes through an intravenous infusion immediately after the first dose of KML-001

Sponsors & Collaborators

  • University of Maryland, College Park

    collaborator OTHER

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Martin Edelman, MD · University of Maryland, College Park

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-27
Primary Completion
2015-10-22
Completion
2015-10-27

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01110226 on ClinicalTrials.gov