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Completed

NCT Number: NCT00982267

A Trial Of SU14813 In Patients With Advanced Solid Malignancies

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

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Key information

Conditions

Neoplasms Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Hamburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SU014813

Drug

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

Primary outcomes

  1. Maximum Tolerated Dose (MTD)

    Time frame: 18-Nov-2008

Secondary outcomes

  1. Determine the recommended Phase 2 dose (RP2D)

    Time frame: 18-Nov-2008

  2. Preliminary information on SU014813 anti-tumor effect;

    Time frame: 18-Nov-2008

  3. Plasma pharmacokinetics

    Time frame: 18-Nov-2008

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

    Time frame: 18-Nov-2008

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2008
Study completion
2011
First posted
Sep 23, 2009
Registry last updated
Aug 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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