Testing AZD1775 inC Combination With Radiotherapy and Chemotherapy in Cervical, Upper Vaginal and Uterine Cancers
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 24
Summary
- Conditions
- Malignant Female Reproductive System Neoplasm
- Cervical Carcinoma
- Stage IIIA Uterine Corpus Cancer AJCC v7
- Endometrioid Adenocarcinoma
- Recurrent Cervical Carcinoma
- Stage II Uterine Corpus Cancer AJCC v7
- Stage IIIB Uterine Corpus Cancer AJCC v7
- Stage II Vaginal Cancer AJCC v6 and v7
- Stage IIIA Cervical Cancer AJCC v6 and v7
- Stage IIIC Uterine Corpus Cancer AJCC v7
- Stage III Vaginal Cancer AJCC v6 and v7
- Stage I Uterine Corpus Cancer AJCC v7
- Stage IIIB Cervical Cancer AJCC v6 and v7
- Stage I Vaginal Cancer AJCC v6 and v7
- Stage IIB Cervical Cancer AJCC v6 and v7
- Vaginal Carcinoma
- Stage IA Uterine Corpus Cancer AJCC v7
- Stage IB Cervical Cancer AJCC v6 and v7
- Stage III Cervical Cancer AJCC v6 and v7
- Stage IIA Cervical Cancer AJCC v7
- Stage IB Uterine Corpus Cancer AJCC v7
- Stage IB2 Cervical Cancer AJCC v6 and v7
- Stage II Cervical Cancer AJCC v7
- Stage III Uterine Corpus Cancer AJCC v7
- 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
- Only males
Description
PRIMARY OBJECTIVE: I. To determine the recommended phase II dose (RP2D) and safety profile of adavosertib (AZD1775) in combination with radiotherapy and concurrent cisplatin in patients with gynecological cancers. SECONDARY OBJECTIVES: I. To determine the acute and late toxicity of AZD1775 when admi...
PRIMARY OBJECTIVE: I. To determine the recommended phase II dose (RP2D) and safety profile of adavosertib (AZD1775) in combination with radiotherapy and concurrent cisplatin in patients with gynecological cancers. SECONDARY OBJECTIVES: I. To determine the acute and late toxicity of AZD1775 when administered to patients with gynecological cancer in combination with standard radiotherapy and concurrent cisplatin. II. To evaluate the pharmacodynamic effects of AZD1775 when administered in combination with radiotherapy and concurrent cisplatin (in particular, for the 15 patients treated in an expansion cohort at the RP2D). III. To obtain preliminary information about the progression-free survival, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or clinical progression, of AZD1775 in combination with standard radiotherapy and concurrent cisplatin in women with gynecological cancer. OUTLINE: This is a dose-escalation study of adavosertib. Patients undergo external beam radiation therapy on days 1-5 and receive adavosertib orally (PO) on days 1, 3, and 5 or once daily (QD) on days 1-5 and cisplatin intravenously (IV) over 1 hour on day 1 or 3. Cycles repeat each week for up to 5 weeks in the absence of disease progression of unacceptable toxicity. After completion of study treatment, patients are followed up at 28 days and then every 4 months for 2 years.
Tracking Information
- NCT #
- NCT03345784
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Stephanie Lheureux University Health Network Princess Margaret Cancer Center LAO