First in Patient Study for PF-06840003 in Malignant Gliomas

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Oligodendroglioma; Astrocytoma; Malignant Glioma

Treatments: Drug: PF-06840003

Study type: Interventional

Funder types: Industry

Identifiers

NCT02764151

C0591001

Details and patient eligibility

About

This study will evaluate the safety and tolerability of increasing doses of PF-06840003 in patients with malignant gliomas.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of WHO Grade IV glioblastoma or WHO Grade III anaplastic gliomas
• For patients with Grade IV GBM, recurrent disease at the time of the first or second recurrence or progression. For patients with Grade III anaplastic gliomas, recurrent disease at the time of at least a first recurrence but no more than a fourth recurrence or progression
• Karnofsky performance score greater than or equal to 70%
• Adequate bone marrow, kidney and liver function

Exclusion criteria

• History of CNS bleeding within 6 months of registration
• Previous anti-angiogenics or anti-vascular endothelial growth factor within 12 months of registration
• Requires treatment with high dose systemic corticosteroids defined as >2 mg/day
• Radiation therapy within 12 weeks of registration

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

PF-06840003

Experimental group

Description:

Daily Oral PF-06840003

Treatment:

Drug: PF-06840003