A Trial Of SU14813 In Patients With Advanced Solid Malignancies

Pfizer

Status and phase: Completed; Phase 1

Conditions: Neoplasms; Solid Tumors

Treatments: Drug: SU014813

Study type: Interventional

Funder types: Industry

Identifiers

NCT00982267

RTKD-7840-002

A6191002

Details and patient eligibility

About

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

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 1 patient group

SU014813

Experimental group

Treatment:

Drug: SU014813