Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Oropharyngeal Squamous Cell Carcinoma
- Advanced Head and Neck Squamous Cell Carcinoma
- Advanced Hypopharyngeal Squamous Cell Carcinoma
- Advanced Laryngeal Squamous Cell Carcinoma
- Advanced Oral Cavity Squamous Cell Carcinoma
- Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Stage III Hypopharyngeal Carcinoma AJCC v8
- Stage IVB Laryngeal Cancer AJCC v8
- Stage III Laryngeal Cancer AJCC v8
- Stage IVB Hypopharyngeal Carcinoma AJCC v8
- Stage III Lip and Oral Cavity Cancer AJCC v8
- Stage IVB Lip and Oral Cavity Cancer AJCC v8
- Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVA Hypopharyngeal Carcinoma AJCC v8
- Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVA Lip and Oral Cavity Cancer AJCC v8
- Stage IVA Laryngeal Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To determine the recommended phase 2 dose (RP2D) of M3814 (peposertib) when given in combination with intensity-modulated radiation therapy (IMRT). SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of the combination of M3814 (peposertib) with radiotherapy. II. T...
PRIMARY OBJECTIVE: I. To determine the recommended phase 2 dose (RP2D) of M3814 (peposertib) when given in combination with intensity-modulated radiation therapy (IMRT). SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of the combination of M3814 (peposertib) with radiotherapy. II. To estimate the rates of grade 3 or greater acute toxicities of the regimen. III. To estimate late toxicities of the regimen. IV. To evaluate the clinical response rate, based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, at 3 months post completion of radiotherapy. V. To estimate 6 and 12-month progression-free survival (PFS) in the dose expansion cohort (DEC). VI. To estimate 6 and 12-month overall survival (OS) in the DEC. EXPLORATORY OBJECTIVE: I. To estimate the pharmacokinetic (PK) parameter of M3814 (peposertib) using population PK approaches. OUTLINE: This is a dose-escalation study of peposertib. Patients receive peposertib orally (PO) once daily (QD) and undergo IMRT daily Monday-Friday for 7 weeks in the absence of disease progression or unacceptable toxicity. After completion of treatment, patients are followed up every 3 months for 2 years.
Tracking Information
- NCT #
- NCT04533750
- Collaborators
- NRG Oncology
- Investigators
- Principal Investigator: Maura L Gillison NRG Oncology
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