Oral TrkA Inhibitor VMD-928 for Treatment of Advanced Adult Solid Tumors or Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Gastric Cancer
- Acute Myeloid Leukemia
- Adenoid Cystic Carcinoma
- Prostate Cancer
- Squamous Cell Carcinoma of Lung
- Cervical Cancer
- Thymic Carcinoma and Thymoma
- Esophageal Cancer
- Head and Neck Squamous Cell Carcinoma
- Hepatocellular Carcinoma
- Melanoma
- Mesothelioma
- Non Hodgkin Lymphoma
- Ovarian Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Sequential AssignmentIntervention Model Description: Part 1, Dose Escalation: Identify the RP2D (complete); Parts 2-4, Cohort Expansion with RP2D (ongoing); Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is an open-label, Phase I, FTIH, multiple-dose, dose-escalation and cohort expansion multi-center study conducted in three parts to identify a safe and pharmacologically active dose and regimen for VMD-928 monotherapy, which can be implemented in Phase 2 studies (the RP2D). The regimen will be ...
This is an open-label, Phase I, FTIH, multiple-dose, dose-escalation and cohort expansion multi-center study conducted in three parts to identify a safe and pharmacologically active dose and regimen for VMD-928 monotherapy, which can be implemented in Phase 2 studies (the RP2D). The regimen will be identified using an adaptive design, multiple-ascending dose study in cancer patients. To conserve patients in the lower dose cohorts, dose escalation will begin with an accelerated titration scheme. A second part of the study will assess antitumor activity at the RP2D. The third part of the study will collect tumor samples before and after treatment to assess biological activity.
Tracking Information
- NCT #
- NCT03556228
- Collaborators
- Not Provided
- Investigators
- Study Director: Peg Fletcher, MD PhD MedAssessment
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