Prospective, explorative trial for the detection of circulating cell-free tumor DNA in the plasma of patients with gastrointestinal stromal tumors (GIST) harboring activating mutations of CKIT or PDGFRA pre/post surgery or pre/under treatment with a tyrosine kinase inhibitor or progressive disease irrespective of current or planned treatmentAn open-label, non-randomized, multicenter phase IIIb clinical trial

Phase 1

• Conditions: Patients with gastrointestinal stromal tumor (GIST) harboring activating mutations of CKIT or PDGFRA pre/post surgery or pre/under treatment with a Tyrokinase Inhibitors or progressive disease irrespective of current or planned treatment.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002544-27-DE
• Lead Sponsor: Technische Universitaet Muenchen Fakultaet fuer Medizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-06
• Last Update Posted: 24 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Signed written informed consent
• Male or female patients aged >18 years
• Histologically confirmed GIST
• Known activating mutation of CKIT or PDGFRA and tissue sample can be provided for central mutation analysis or mutation status unknown and tissue sample can be provided for central mutation analysis at baseline
• Routinely planned follow-up visits in no longer than three months intervals (+ 14 days) including local standard of care diagnostic imaging (CT, PET-CT, or MRI)
• At least one GIST lesion that can be measured by CT, PET-CT, or MRI
• Planned surgery of one or more disease manifestations or planned TKI treatment (such as imatinib or sunitinib) in neoadjuvant or palliative intention or disease progression ir-respective of current/planned treatment
• Life expectancy of at least three months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Wild type sequence for CKIT exon 9, 11, 13, 14, 17, 18 and PDGFRA exon 18
• Tissue sample can not be provided for central mutation analysis
• Surgery of primary or progressive lesions already completed and currently no evidence of progressive lesions
• Patients currently receiving adjuvant TKI treatment after sur-gery and no evidence of progressive lesions
• Patients currently receiving palliative TKI treatment and no evidence of progressive lesions
• Planned follow-up intervals including CT, PET-CT or MRI at more than three months intervals (+ 14 days)
• Coexisting medical condition or treatment that could interfere with the ability of the patient to comply with planned treatment interventions (surgery or TKI treatment) or regular follow-up visits
• Patients unwilling to or unable to comply with the planned therapeutic intervention (surgery or TKI treatment) or to comply with the regular follow-up visits including blood sam-ple collection
• Pregnancy and lactation
• Presence of chronic inflammatory diseases, autoimmune dis-eases, or liver cirrhosis
• Known HIV and/or hepatitis B or C infection
• Other malignancies within the past 3 years except for ade-quately treated carcinoma of the cervix and basal or squamous cell carcinoma of the skin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified