This Is The First Study Using Escalating Doses Of PF-03758309, An Oral Compound, In Patients With Advanced Solid Tumors

Pfizer

Status and phase

Terminated

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: PF-03758309

Study type

Interventional

Funder types

Industry

Identifiers

NCT00932126

B1301001

Details and patient eligibility

About

This is the first study using PF-03758309, an oral compound, in patients with advanced solid tumors. In this study different doses of PF-03758309 will be administered to different groups of patients. The study will assess the compound's safety, the blood levels of PF-03758309 during the treatment and the effect of the compound on the tumor cells.

Full description

The study was prematurely terminated on 26Jul2011 due to the undesirable PK characteristics of PF-03758309 and the lack of an observed dose-response relationship. There were no safety concerns that contributed to the study termination.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available.
ECOG (Eastern Cooperative Oncology Group) Performance Status (PS) must be 0 or 1.
Adequate bone marrow, liver and kidney function.

Exclusion criteria

Patients with known brain metastases.
Previous high dose chemotherapy requiring stem cell rescue.
Prior irradiation to >25% of the bone marrow.
Active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV).
Current active treatment in another clinical study.
Pregnancy or breast feeding.
Active inflammatory gastrointestinal disease, chronic diarrhea (unless related to underlying malignancy or prior related treatment) or history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment.