First In Human, Phase 1 Study of AG013736 In Patients With Solid Tumors

Pfizer

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: AG-013736

Study type

Interventional

Funder types

Industry

Identifiers

NCT01469052

A4060010

AG013736-001

Details and patient eligibility

About

The purpose of the study was to characterize the safety of investigational agent AG-013736, in patients with solid tumors in this First In Human trial.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with cytologically or histologically confirmed solid tumor(s) and with at least one measurable disease site
Patients with adequate bone marrow, liver and kidney function
Patients with life expectancy of at least 12 weeks

Exclusion criteria

Patients who have received chemotherapy, immunotherapy, radiotherapy or any investigational agent within 4 weeks of study entry
Patients with have had a major surgical procedure within 4 weeks of study entry

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 6 patient groups

Cohort 1

Experimental group

Treatment:

Drug: AG-013736

Cohort 2

Experimental group

Treatment:

Drug: AG-013736

Cohort 3

Experimental group

Treatment:

Drug: AG-013736

Cohort 4

Experimental group

Treatment:

Drug: AG-013736

Cohort 5

Experimental group

Treatment:

Drug: AG-013736

Cohort 6

Experimental group

Treatment:

Drug: AG-013736

Trial contacts and locations

3

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