PEN-866 in Patients With Advanced Solid Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 150
Summary
- Conditions
- Carcinoma
- Adenocarcinoma of the Pancreas
- Solid Tumor
- Squamous Cell Carcinoma of the Anus
- Advanced Cancer
- Endometrial Adenocarcinoma
- Gastric Adenocarcinoma
- Small Cell Lung Cancer
- Squamous Cell Carcinoma
- Gastric Cancer
- Gastroesophageal Junction Adenocarcinoma
- Neoplasms
- Pancreatic Adenocarcinoma
- Pancreatic Ductal Adenocarcinoma
- Squamous Cell Carcinoma of the Penis
- Squamous Cell Carcinoma of the Vulva
- Small Cell Lung Carcinoma
- Squamous Cell Carcinoma of the Cervix
- Solid Carcinoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention 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
Phase 1a will employ an adaptive model guided with overdose control principle to make dose recommendations and estimate the maximum tolerated dose (MTD) of PEN-866 (single agent). Phase 1b will employ a standard 3 + 3 design to make dose recommendations and estimate the MTD of PEN-866 in combination...
Phase 1a will employ an adaptive model guided with overdose control principle to make dose recommendations and estimate the maximum tolerated dose (MTD) of PEN-866 (single agent). Phase 1b will employ a standard 3 + 3 design to make dose recommendations and estimate the MTD of PEN-866 in combination therapy. Phase 2a (single agent) will assess the safety, tolerability, pharmacokinetic, and pharmacodynamics profile of PEN-866 (single agent) at the recommended Phase 2 dose determined at the conclusion of Phase 1a in patients with advanced solid malignancies.
Tracking Information
- NCT #
- NCT03221400
- Collaborators
- Not Provided
- Investigators
- Study Chair: Anish Thomas, MD National Cancer Institute (NCI)
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