NCT01248949

A Study to Evaluate the Safety and Antitumor Activity in Subjects With Advanced Solid Tumors

Phase 1/1b, Open-Label, Dose-Escalation and Expansion Study to Evaluate the Safety and Antitumor Activity of MEDI3617 as a Single-Agent or in Combination Therapy in Adult Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

To determine the maximum tolerated dose or optimal biological dose, and the safety profile of MEDI3617 when given as a single-agent or in combination with other chemotherapeutic agents in subjects with advanced solid malignancies resistant to standard therapy.

Conditions

• Advanced Solid Tumors
• Advanced Recurrent Ovarian Tumors

Interventions

Type	Name	Description
DRUG	MEDI3617	Participants will receive MEDI3617 via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.
DRUG	Bevacizumab	Participants will receive bevacizumab via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.
DRUG	Paclitaxel	Participants will receive paclitaxel via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons.
DRUG	Carboplatin	Participants will receive carboplatin via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons.

Timeline

• Start date: 2010-10-01
• Primary completion: 2015-07-01
• Completion: 2015-10-01
• First posted: 2010-11-25
• Last updated: 2017-03-29
• Results posted: 2017-03-29

Locations

10 sites across 1 country: United States