NCT02709889

Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors

An Open-Label Study of Rovalpituzumab Tesirine in Subjects With Delta-Like Protein 3-Expressing Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the safety and tolerability of rovalpituzumab tesirine in subjects with specific delta-like protein 3-expressing advanced solid tumors.

Detailed description

This is a multicenter, open-label study involving multiple specific advanced solid tumor types, consisting of a dose escalation part A followed by an expansion part B. Cancer subtypes will be studied in separate disease-specific cohorts in both Parts. Eight separate cohorts will enroll malignant melanoma, medullary thyroid cancer (MTC), glioblastoma, large cell neuroendocrine carcinoma (LCNEC), neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other NEC, and solid tumors other than the above.

Conditions

• Malignant Melanoma
• Medullary Thyroid Cancer
• Glioblastoma
• Large-Cell Neuroendocrine Carcinoma
• Neuroendocrine Prostate Cancer
• High Grade Gastroenteropancreatic Neuroendocrine Carcinoma
• Other Neuroendocrine Carcinoma
• Other Solid Tumors

Interventions

Type	Name	Description
DRUG	Rovalpituzumab tesirine
DRUG	Dexamethasone	Dexamethasone will be provided through a participant's local prescription by Investigator or other provider (i.e., dexamethasone will not be provided by the Sponsor).

Timeline

• Start date: 2016-09-23
• Primary completion: 2019-08-27
• Completion: 2019-08-27
• First posted: 2016-03-16
• Last updated: 2020-10-19
• Results posted: 2020-10-19

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated drug study