A phase Ib dose escalation/randomized phase II, multicenter, open-label study of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma

Completed

• Conditions: Head and neck cancer; 10027655

• Registration Number: NL-OMON40123
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

- Age * 18 years
- Patients with histologically/cytologically-confirmed HNSCC
- Patients must be resistant to platinum-based chemotherapy, or be ineligible or intolerant to platinum-based therapy
- For Phase Ib only, at least 1 prior therapy for recurrent or metastatic disease
- For Phase II only, a maximum of 1 prior therapy for recurrent or metastatic disease
- Prior cetuximab or another EGFR-targeted antibody therapy is allowed only if administered in the induction setting, or concurrently with radiation in the curative setting, with the last dose of cetuximab administered at least 12 months prior to starting the study treatment
- Availability of tumor specimen (primary or metastatic, archival or fresh)
- At least one measurable or non-measurable lesion is required for patients enrolled in Phase Ib. Measurable disease is required for Phase II patients (as per RECIST 1.1 criteria)
- WHO Performance Status (PS) * 2.
- Adequate organ function and laboratory parameters
- Negative serum pregnancy test ;NEW
-For Arm 3, prior cetuximab incl. platinum as therapeutic setting and disease progression documented within 9 months of the last dose of cetuximab administered in that setting.
- Patients enrolled in Arm 3 must have amenable sites to biopsy;More detailed inclusion criteria see protocol section 5.2

Exclusion Criteria

- Prior treatment with PI3K-inhibitors
- Patients with a prior serious infusion reaction to cetuximab
- Patients with primary central nervous system (CNS) tumor or CNS tumor involvement
- Clinically significant cardiac disease or impaired cardiac function
- Patients with diabetes mellitus
- Impaired GI function or GI disease that may signifincant alter the absorption of oral BYL719
- History of another malignancy within 2 years prior to starting study treatment ;More detailed exclusion criteria see protocol section 5.3

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence of DLTs (phase Ib), progression free survival (phase II).<br /><br><br /><br>PROTOCOL AMENDEMENT 5<br /><br>Phase Ib Arm-C: AUCO-24</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Adverse events, dose interruptions, reductions, dose density, PK (phase IB),<br /><br>overall response rate, disease control rate, overall survival, overall survival<br /><br>rate at month 6.<br /><br><br /><br>PROTOCOL AMENDMENT 5<br /><br>Plasma concentration vs. time profiles, plasma PK parameters of BYL719 in Arm C</p><br>