NCT00982267

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2009

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

August 8, 2011

Status Verified

August 1, 2011

Enrollment Period

4.9 years

First QC Date

September 22, 2009

Last Update Submit

August 4, 2011

Conditions

NeoplasmsSolid Tumors

Keywords

cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD)

    18-Nov-2008

Secondary Outcomes (4)

  • Determine the recommended Phase 2 dose (RP2D)

    18-Nov-2008

  • Preliminary information on SU014813 anti-tumor effect;

    18-Nov-2008

  • Plasma pharmacokinetics

    18-Nov-2008

  • Plasma targets such as vascular endothelial growth factor (VEGF), soluble VEGF-R2 and soluble KITa

    18-Nov-2008

Study Arms (1)

SU014813

EXPERIMENTAL
Drug: SU014813

Interventions

SU014813DRUG

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

SU014813

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

Hamburg, 20246, Germany

Location

Pfizer Investigational Site

Amsterdam, 1081 HV, Netherlands

Location

Related Publications (1)

  • Fiedler W, Giaccone G, Lasch P, van der Horst I, Brega N, Courtney R, Abbattista A, Shalinsky DR, Bokemeyer C, Boven E. Phase I trial of SU14813 in patients with advanced solid malignancies. Ann Oncol. 2011 Jan;22(1):195-201. doi: 10.1093/annonc/mdq313. Epub 2010 Jul 6.

    PMID: 20605934DERIVED

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 22, 2009

First Posted

September 23, 2009

Study Start

December 1, 2003

Primary Completion

November 1, 2008

Study Completion

June 1, 2011

Last Updated

August 8, 2011

Record last verified: 2011-08

Locations

NL(1)DE(1)