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Sunitinib for Advanced Thymus Cancer Following Earlier Treatment

NCT01621568 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-09-24

Study results available
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Summary

Background:

\- Sunitinib is drug that is approved for treating various types of cancers, including kidney cancers. However, it has not been approved to treat cancers of the thymus. Sunitinib works by blocking proteins that are responsible for cell division and growth. Some of these proteins can be found on thymus cancer cells. Researchers want to see if sunitinib can be used to treat advanced thymus cancer. It will be given to people who have had at least one earlier chemotherapy treatment containing platinum.

Objectives:

\- To see if sunitinib is a safe and effective treatment for advanced thymus cancer that has not responded to earlier treatments.

Eligibility:

* Individuals at least 18 years of age who have advanced thymus cancer that has not responded to earlier treatments.
* At least one previous cancer treatment must have been chemotherapy treatment containing platinum.

Design:

* Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies and tumor biopsies will be used to check the severity of the cancer.
* Participants will take sunitinib tablets once a day, in the morning. They will take the tablets daily for 4 weeks, followed by 2 weeks of rest with no sunitinib. This 6-week period is called a cycle.
* Treatment will be monitored with frequent blood tests and imaging studies.
* Treatment cycles may be repeated as long as the tumor does not continue to grow and there are no severe side effects....

Conditions

  • Thymoma
  • Thymus Neoplasms

Interventions

DRUG

Sunitinib

50mg/day for 4 weeks daily, by mouth with 2 weeks off (6 week cycle)

DRUG

Sunitinib

50mg/day for 2 weeks daily, by mouth with 1 week off (3 week cycle)

Sponsors & Collaborators

  • Indiana University School of Medicine

    collaborator OTHER

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Arun Rajan, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-15
Primary Completion
2021-04-30
Completion
2024-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT01621568 on ClinicalTrials.gov