A phase II study of saracatinib (AZD0530), a Src inhibitor, administered orally daily to patients with advanced thymic malignancies

Matthew A. Gubens, Matthew Burns, Susan Perkins, Melanie San Pedro-Salcedo, Sandy K. Althouse, Patrick Loehrer, Heather A. Wakelee

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

Objectives: Thymic malignancies are rare, and options are limited for metastatic disease. Src plays a role in normal thymic epithelial maturation, and its inhibition with the oral compound saracatinib was postulated to be effective in controlling thymic malignancy. Materials and methods: Patients with unresectable thymic malignancy were treated with saracatinib 175. mg by mouth daily in 28 days cycles with radiographic evaluation at cycle 2 day 1 for safety, then cycle 3 day 1 and every 8 weeks thereafter. Response was evaluated by RECIST 1.0. A two-stage optimal design was used, powered to detect a true response rate of 20%. Results: 21 patients were enrolled at two institutions, 12 of them with thymoma, 9 with thymic carcinoma. Thymoma patients received a median of 4.5 cycles and thymic carcinoma patients a median of 1 cycle. There were no responses, so accrual was halted after the first stage per protocol. 9 patients had stable disease beyond the first assessment. Median time to progression was 5.7 months for thymoma patients and 3.6 months for thymic carcinoma patients. Saracatinib was well tolerated. Conclusion: Src inhibition by saracatinib did not produce any radiographic responses, though some patients did experience stable disease. Though negative, this study shows the feasibility of completing a trial in this rare disease, and of accruing reasonably significant numbers of thymic carcinoma patients. More clinical trials are required for this population (NCT00718809).

Original languageEnglish (US)
Pages (from-to)57-60
Number of pages4
JournalLung Cancer
Volume89
Issue number1
DOIs
StatePublished - Jul 1 2015

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Thymoma
Neoplasms
saracatinib
Feasibility Studies
Rare Diseases
Mouth
Clinical Trials
Safety
Population

Keywords

  • AZD0530
  • Saracatinib
  • Src inhibition
  • Thymic carcinoma
  • Thymoma

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

A phase II study of saracatinib (AZD0530), a Src inhibitor, administered orally daily to patients with advanced thymic malignancies. / Gubens, Matthew A.; Burns, Matthew; Perkins, Susan; Pedro-Salcedo, Melanie San; Althouse, Sandy K.; Loehrer, Patrick; Wakelee, Heather A.

In: Lung Cancer, Vol. 89, No. 1, 01.07.2015, p. 57-60.

Research output: Contribution to journalArticle

Gubens, Matthew A. ; Burns, Matthew ; Perkins, Susan ; Pedro-Salcedo, Melanie San ; Althouse, Sandy K. ; Loehrer, Patrick ; Wakelee, Heather A. / A phase II study of saracatinib (AZD0530), a Src inhibitor, administered orally daily to patients with advanced thymic malignancies. In: Lung Cancer. 2015 ; Vol. 89, No. 1. pp. 57-60.
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