Pilot Study of Imatinib (Gleevec) as Treatment for Advanced Thymic Carcinoma
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ClinicalTrials.gov Identifier: NCT00314873 |
Recruitment Status :
Completed
First Posted : April 17, 2006
Last Update Posted : June 3, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Thymic Carcinoma | Drug: Gleevec (imatinib) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pilot Study of Imatinib (Gleevec) as Treatment for Advanced Thymic Carcinoma |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | March 2011 |
Actual Study Completion Date : | March 2011 |

- Drug: Gleevec (imatinib)
Imatinib 600mg po qd X 21 days.
- To determine the objective response rate of imatinib in patients with c-kit or PDGF positive thymic carcinoma. [ Time Frame: baseline through progression ]
- To determine the duration of remission of patients with thymic carcinoma treated with imatinib. [ Time Frame: baseline through progression ]
- To determine the toxicity of imatinib in this patient population. [ Time Frame: baseline through end of study ]
- To determine the incidence of kit mutations in thymic malignancies. [ Time Frame: baseline ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histological or cytological proof of advanced C-KIT positive or PDGFR positive thymic carcinoma. For protocol purposes, advanced disease is defined as disease
- Patient must have at least one documented measurable lesion obtained by imaging within 28 days prior to being registered for protocol therapy.
- No prior imatinib therapy.
- Age > 18 years at the time of consent
- ECOG performance status of 0 or 1
- ANC ≥ 1500/mm3,Platelet count ≥ 100,000/mm,Total bilirubin < 1.5ULN,3.10 Serum creatinine ≤ 1.7 mg/dl,ALT and AST ≤ 3 x ULN
Exclusion Criteria:
- Clinically significant infections as judged by the treating investigator
- Clinically significant concurrent illnesses
- Females of childbearing potential not using birth control or breastfeeding
- Prior radiation therapy > 25% of the bone marrow
- Symptomatic brain metastasis
- History of Grade III/IV cardiac problems
- History of major surgery within 14 days prior to being registered
- Treatment with any investigational agent within 30 days prior to being registered for protocol therapy.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314873
United States, Indiana | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202 |
Principal Investigator: | Patrick Loehrer | Indiana University |
Responsible Party: | Indiana University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00314873 |
Other Study ID Numbers: |
0603-21/ IUCRO-0147 |
First Posted: | April 17, 2006 Key Record Dates |
Last Update Posted: | June 3, 2014 |
Last Verified: | May 2014 |
Thymic malignancy Thymic Carcinoma |
Carcinoma Thymoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Complex and Mixed Thymus Neoplasms Thoracic Neoplasms |
Neoplasms by Site Lymphatic Diseases Imatinib Mesylate Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |