A Trial Of SU14813 In Patients With Advanced Solid Malignancies

August 4, 2011 updated by: Pfizer

A Phase I Dose Escalating Study Of SU014813 In Patients With Solid Tumors Not Amenable To Conventional Therapy

The purpose of this study is to define the Maximum tolerated dose of SU14813 when administered as single agent in patients with solid tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Pfizer Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a histologically proven advanced solid malignancy for which no recognized therapy was available or for which standard therapy had failed
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Serum albumin ≥3.0 g/dL and adequate haemopoietic, renal and liver function

Exclusion Criteria:

  • Chemotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) or radiotherapy or an investigational agent within 4 weeks before the start of study treatment
  • Subjects had to have recovered from all prior treatment toxicities, except alopecia, and from any major surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SU014813
Drug: SU014813
Escalating doses of SU014813 from 50 to 250mg/day . Capsules administered daily either as continuous dosing or in cycles of 4 weeks on 1 week off

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Tolerated Dose (MTD)
Time Frame: 18-Nov-2008
18-Nov-2008

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine the recommended Phase 2 dose (RP2D)
Time Frame: 18-Nov-2008
18-Nov-2008
Preliminary information on SU014813 anti-tumor effect;
Time Frame: 18-Nov-2008
18-Nov-2008
Plasma pharmacokinetics
Time Frame: 18-Nov-2008
18-Nov-2008
Plasma targets such as vascular endothelial growth factor (VEGF), soluble VEGF-R2 and soluble KITa
Time Frame: 18-Nov-2008
18-Nov-2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (ACTUAL)

November 1, 2008

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

September 22, 2009

First Submitted That Met QC Criteria

September 22, 2009

First Posted (ESTIMATE)

September 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 8, 2011

Last Update Submitted That Met QC Criteria

August 4, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RTKD-7840-002
  • A6191002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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