A Trial Of SU14813 In Patients With Advanced Solid Malignancies

NCT ID: NCT00982267

Last Updated: 2011-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2011-06-30

Brief Summary

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

Detailed Description

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Conditions

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Neoplasms Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SU014813

Group Type EXPERIMENTAL

SU014813

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Hamburg, , Germany

Site Status

Pfizer Investigational Site

Amsterdam, , Netherlands

Site Status

Countries

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Germany Netherlands

References

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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.

Reference Type DERIVED
PMID: 20605934 (View on PubMed)

Related Links

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Other Identifiers

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A6191002

Identifier Type: -

Identifier Source: secondary_id

RTKD-7840-002

Identifier Type: -

Identifier Source: org_study_id

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