Saracatinib in Treating Patients With Relapsed or Refractory Thymoma or Thymic Cancer

NCT00718809 | Terminated Phase 2 Results

• 2 other identifiers: NCI-2009-00297IUCRO-0214
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

This phase II trial is studying how well saracatinib works in treating patients with relapsed or refractory thymoma or thymic cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Conditions

Invasive Thymoma and Thymic Carcinoma; Recurrent Thymoma and Thymic Carcinoma; Stage III Thymoma; Stage IVA Thymoma; Stage IVB Thymoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (Complete and Partial Response)

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The objective response rate will be reported by each disease classification. The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. Note: there were no objective responses in this trial.

  Up to 5 years

Secondary Outcomes (4)

• Progression-free Survival

  Time from the date of registration to the first reported outcome event, assessed up to 5 years

• Overall Survival

  Time from the date of registration to last reported date of survival, assessed up to 5 years

• Disease Control Rate

  Up to 5 years

• Expected Toxicities Including Skin Rashes and Diarrhea

  Up to 5 years

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: saracatinib

Interventions

saracatinib DRUG

Given orally

Also known as: AZD0530

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed invasive thymoma or thymic carcinoma, meeting the following criteria:
• Relapsed or refractory disease
• Metastatic, unresectable disease
• Locally invasive disease allowed provided it is not resectable and has been previously treated
• Progressive disease
• Measurable disease, defined as \>= 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques or \>= 10 mm by spiral CT scan
• Must have received \>= 1 prior chemotherapy regimen
• No active brain metastases
• Patients with previously treated brain metastases (surgical resection or radiotherapy) are eligible provided they have documented stable brain disease for \>= 1 month after completion of therapy and are asymptomatic
• ECOG performance status 0-2
• Leukocytes \>= 3,000/mm\^3
• ANC \>= 1,500/mm\^3
• Platelet count \>= 100,000/mm\^3
• Hemoglobin \> 9 g/dL
• Serum bilirubin \< 2.0 times upper limit of normal (ULN)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Stanford University Hospitals and Clinics

Stanford, California, 94305, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Gubens MA, Burns M, Perkins SM, Pedro-Salcedo MS, Althouse SK, Loehrer PJ, Wakelee HA. A phase II study of saracatinib (AZD0530), a Src inhibitor, administered orally daily to patients with advanced thymic malignancies. Lung Cancer. 2015 Jul;89(1):57-60. doi: 10.1016/j.lungcan.2015.04.008. Epub 2015 Apr 25.

  PMID: 26009269 DERIVED

MeSH Terms

Conditions

Thymoma

Interventions

saracatinib

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Dr. Patrick Loehrer
• Organization: IndianaU

ploehrer@iu.edu

317-944-0920

Study Officials

• Patrick Loehrer

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 21, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: October 1, 2013
• Last Updated: June 10, 2015
• Results First Posted: June 10, 2015

Record last verified: 2014-10

Locations

US (2)