A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors

Pfizer

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: PF-06647020 combined with Avelumab; Drug: fluconazole; Drug: PF-06647020 Q3W; Drug: PF-06647020 Q2W

Study type: Interventional

Funder types: Industry

Identifiers

NCT02222922

2014-003296-36 (EudraCT Number)

B7661001

Details and patient eligibility

About

To assess the safety and tolerability at increasing dose levels of PF-06647020 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Q2W Inclusion Criteria:

• Diagnosis of platinum resistant or refractory OVCA having received 2 or fewer prior lines, or recurrent advanced NSCLC having received 3 or fewer prior lines
• Performance Status of 0, 1, or 2
• Adequate bone marrow, kidney, and liver function

Q2W Exclusion Criteria:

• OVCA pts excluded with any of the following: non-epithelial, including malignant mixed mullerian tumors, unresolved bowel obstruction
• Brain metastases requiring steroids
• Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start
• Active and clinically significant bacterial, fungal, or viral infection

Q3W Inclusion Criteria:

• Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available
• Performance Status of 0 or 1
• Adequate bone marrow, kidney, and liver function
• Part 2 includes ovarian cancer, target expressing triple negative breast cancer and non small cell lung cancer patients

Q3W Exclusion Criteria:

• OVCA pts excluded with any of the following: non-epithelial, including malignant mixed mullerian tumors, prior radiotherapy to pelvis/abdomen, pts with CA-125 only disease, unresolved bowel obstruction
• Brain metastases requiring steroids
• Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start
• Active and clinically significant bacterial, fungal, or viral infection

Trial design

138 participants in 4 patient groups

PF-06647020 Q3W

Experimental group

Description:

Investigational drug infused over 60 minutes once every 21 days.

Treatment:

Drug: PF-06647020 Q3W

Drug-drug interaction (DDI)

Experimental group

Description:

PF-06647020 combined with fluconazole

Treatment:

Drug: fluconazole

PF-06647020 Q2W

Experimental group

Description:

Investigational drug infused over 60 minutes once every 14 days (28 day cycle)

Treatment:

Drug: PF-06647020 Q2W

PF-06647020 combined with Avelumab

Experimental group

Description:

PF-06647020 combined with Avelumab administered by infusion

Treatment:

Drug: PF-06647020 combined with Avelumab