A Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated NSCLC

NCT01957007 | Completed Phase 1

• 1 other identifier: 18R5-004
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

Brief Summary

This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with docetaxel.

Conditions

Solid Tumors

Keywords

Phase 1; dose escalation; histologically confirmed; malignancy metastatic

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of vantictumab in combination with docetaxel in patients with recurrent or advanced NSCLC. The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with weekly paclitaxel.

  Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28)

Secondary Outcomes (1)

• Pharmacokinetics (PK) of vantictumab when administered in combination with docetaxel to patients with recurrent or advanced NSCLC

  Plasma sample for Pharmacokinetics (PK) analysis to be obtained prior to the vantictumab infusion and before docetaxel infusion from Day 0 to treatment termination

Study Arms (2)

Docetaxel

EXPERIMENTAL

Drug: Docetaxel - administered intravenously

Drug: Docetaxel; Drug: vantictumab

vantictumab

EXPERIMENTAL

Drug: vantictumab - administered intravenously

Drug: Docetaxel; Drug: vantictumab

Interventions

Docetaxel DRUG

Docetaxel will be administered IV.

Docetaxel; vantictumab

vantictumab DRUG

Vantictumab will be administered intravenously

Also known as: (OMP-18R5)

Docetaxel; vantictumab

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form
• Age ≥18 years
• Histologically documented recurrent or advanced (Stage IV) NSCLC
• Eastern CooperativeOncology Group (ECOG) performance status of 0 or 1
• All acute treatmentrelated toxicity from prior therapy must have resolved to Grade ≤ 1 prior to study entry
• Adequate hematologic and end-organ function
• Evaluable or measurable disease per RECIST v1.1
• For women of childbearing potential and men with partners of childbearing potential, agreement to use two effective forms of contraception

You may not qualify if:

• Prior treatment with docetaxel for recurrent or advanced NSCLC
• More than two regimens of systemic cytotoxic chemotherapy for recurrent or advanced NSCLC
• Treatment with any anti-cancer therapy within 3 weeks prior to initiation of study treatment
• Known hypersensitivity to any component of study treatments
• Grade ≥ 2 sensory neuropathy
• Uncontrolled seizure disorder or active neurologic disease
• Untreated brain metastases
• Leptomeningeal disease as a manifestation of cancer
• Active infection requiring antibiotics
• Bisphosphonate therapy for symptomatic hypercalcemia
• Known history of clinically significant liver disease, including active viral hepatitis and cirrhosis
• Significant intercurrent illness including, but not limited to, unstable angina pectoris, and cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
• Pregnancy, lactation, or breastfeeding
• Known HIV infection
• Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)

Sponsors & Collaborators

• OncoMed Pharmaceuticals, Inc.: lead

Study Sites (3)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Roswell Park Cancer Center, Elm & Carlton Streets

Buffalo, New York, 14263, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Interventions

Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2013
• First Posted: October 8, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

US (3)