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Phase I Study of TAK-701 in Adult Patients With Advanced Nonhematological Malignancies

NCT00831896 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2011-12-02

No results posted yet for this study

Summary

This study is a multicenter, open-label, dose escalation, phase 1 study of TAK 701 in adult patients with advanced nonhematologic malignancies. This study will be the first to administer TAK 701 to humans. The primary purpose of this study is to determine the safety profile, tolerability, and pharmacokinetics profile of TAK-701.

Conditions

Interventions

BIOLOGICAL

TAK-701

Either 2, 5, 10, or 20 mg/kg IV. Cycle 1: single dose at 2x the dose assignment; Cycle 2 and beyond: dose once every two weeks Dosing continues until disease progression, unacceptable toxicity related to TAK-701, or maximum of 12 cycles, unless determined that patient would benefit from continued therapy.

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Millennium Pharmaceuticals, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-11-30
Completion
2011-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00831896 on ClinicalTrials.gov