A Trial Of SU14813 In Patients With Advanced Solid Malignancies

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982267
• Other study ID #: RTKD-7840-002
• Secondary ID: A6191002
• Status: Completed
• Phase: Phase 1
• First received: September 22, 2009
• Last updated: August 4, 2011
• Start date: December 2003
• Est. completion date: June 2011

Study information

• Verified date: August 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: June 2011
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

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

Locations

Country	Name	City	State
Germany	Pfizer Investigational Site	Hamburg
Netherlands	Pfizer Investigational Site	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD)		18-Nov-2008	Yes
Secondary	Determine the recommended Phase 2 dose (RP2D)		18-Nov-2008	Yes
Secondary	Preliminary information on SU014813 anti-tumor effect;		18-Nov-2008	No
Secondary	Plasma pharmacokinetics		18-Nov-2008	No
Secondary	Plasma targets such as vascular endothelial growth factor (VEGF), soluble VEGF-R2 and soluble KITa		18-Nov-2008	No

External Links

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