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Pemetrexed for the Treatment of Chordoma

NCT03955042 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-03-07

No results posted yet for this study

Summary

The purpose of this study is to test the safety and tolerability of pemetrexed administered to people with chordoma. Other purposes of this study are to:

* find out side effects (good and bad) of pemetrexed;
* learn more about how pemetrexed might affect the growth of cancer cells;
* evaluate tumor characteristics by collecting tumor tissue samples if available;
* look at biomarkers (biochemical features that can be used to measure the progress of disease or the effects of a drug) in blood and cerebrospinal fluid if available.

Conditions

  • Chordoma

Interventions

DRUG

Pemetrexed

Pemetrexed 900 mg/m\^2 on Day 1 of each 21-day cycle. Supportive medications of ibuprofen, folic acid, vitamin B12, and dexamethasone.

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Chordoma Foundation

    collaborator OTHER

  • Saint John's Cancer Institute

    lead OTHER

Principal Investigators

  • Santosh Kesari, MD, PhD · Saint John's Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-06
Primary Completion
2022-07-27
Completion
2023-01-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03955042 on ClinicalTrials.gov