A Safety Study Of A Monoclonal Antibody Against A5B1 Integrin In Solid Tumors

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Advanced Non-Hematologic Malignancies

Treatments: Drug: PF-04605412

Study type: Interventional

Funder types: Industry

Identifiers

NCT00915278

B1001001

Details and patient eligibility

About

Dose finding study of the MoaB PF-04605412 directed against the alpha5beta1 integrin. Main objective is to define the MTD (maximum tolerated dose) or MAD (maximum administrable dose) in cancer patients pre treated or unresponsive to standard therapies.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed advanced measurable or evaluable solid tumors unresponsive to currently available therapies, or for which there is no curative therapy
• Eastern Cooperative Oncology Group (ECOG) performance status 0 and 1
• Life expectancy more than12 weeks
• Adequate bone marrow, liver and renal function

Exclusion criteria

• Known brain metastasis
• Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of start of screening procedures
• Major surgical procedure within 4 weeks of start of screening procedures
• Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, significant hemoptysis or melena in the past 6 months

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

PF-04605412

Experimental group

Treatment:

Drug: PF-04605412