Clinical Performance Study Plan for FoundationOne®CDx Used as a Clinical Trial Assay in Clinical Trial PRIMROSE: A Modular Phase I/IIa, Multi-centre, Dose Escalation, and Expansion Study of AZD3470, a MTA Cooperative PRMT5 Inhibitor, as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours That are MTAP Deficient

• Conditions: metastatic solid tumors; Selected metastatic solid tumors that are MTAP deficient; 10027476

• Registration Number: NL-OMON56824
• Lead Sponsor: Astra Zeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 11

Inclusion Criteria

• Primary Specimen ID and Subject ID accompanying sample
• Optimal tissue volume of at least 0.6 mm3 or absolute minimum tissue volume
of 0.2 mm3
• Final percent tumor nuclei of at least 20% (optimally 30% or greater)
• Sufficient cellularity - determined by Foundation Medicine, Inc. pathologist
discretion.
• Archival or newly collected FFPE tumor samples from the most recently
collected tumor tissue sample, derived from the primary or recurrent cancer
site.
• FFPE specimens, including tumor resections and core needle biopsies.
• 10 x 4 micron sections on positively charged slides, minimum of 3 consecutive
slides
• Slides sectioned within 12 months.
• Recommended FFPE block size is 25 mm x 25 mm

Exclusion Criteria

Fine-needle aspirates (FNA) and effusion cytology samples/other sample types
agreed with study team are NOT accepted.
• Specimens from metastatic bone lesions are unacceptable.
• Sample is fixed in anything other than 10% NBF (e.g. Bouins, B5, Holland*s,
zinc buffered formalin).
• Slides sectioned over 12 months.
• Baked samples above 37 degrees Celsius.
• Blocks larger than 30 x 25 mm cannot be processed.

Study & Design

• Study Type: Interventional
• Study Design: Not specified