A Study of PF-06873600 in People With Cancer

Pfizer

Status and phase: Active, not recruiting; Phase 2

Conditions: HR+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer

Treatments: Drug: Endocrine Therapy 1; Drug: PF-06873600; Drug: Endocrine Therapy 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03519178

C3661001

Details and patient eligibility

About

The purpose of this clinical trial is to learn about the safety and effects of study medicine (PF-06873600) when taken alone or with hormone therapy by people with cancer.

People may be able to participate in this study if they have the following types of cancer: Hormone Receptor positive (HR+) breast cancer; Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer that is advanced or metastatic (spread to other parts of the body); triple negative breast cancer; epithelial ovarian cancer; fallopian tube cancer; or primary peritoneal cancer.

All participants in this study will receive the study medicine by mouth, 1 to 2 times a day at home. The dose of the study medicine may be changed during the study.

Some participants will also receive hormone therapy. The hormone therapy will be either letrozole by mouth once a day at home, or fulvestrant as a shot into the muscle. Fulvestrant will be given every two weeks at the study clinic for the first month, and then once a month after that.

Participants will take part in this study for at least 7 to 8 months, depending on how they respond to the therapy. During this time participants will visit the study clinic once a week.

Full description

This is a Phase 1/2a, open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of PF-06873600 administered as a single agent in sequential dose levels and then in combination with endocrine therapy. In Part 1A and Part 1C, successive cohorts of patients will receive escalating doses of PF-06873600 and then in dose finding (Part 1B) with PF-06873600 in combination with endocrine therapy (ET). This study contains 2 parts, dose escalation with single agent (Part 1A and 1C) and then dose finding with PF-06873600 in combination with endocrine therapy (Part 1B) followed by dose expansion arms of PF-06873600 in combination with endocrine therapy (Part 2).

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer

  • Prior combined CDK 4/6 inhibitor and endocrine therapy and 1 or 2 prior lines of chemotherapy

• Have a diagnosis of metastatic triple negative breast cancer (TNBC)

  • Up to 1-2 prior lines of chemotherapy

• Have a diagnosis of advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC)

  • Up to 2-3 prior lines of therapy

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1

• Measurable disease or non-measurable disease and refractory to or intolerant of existing therapies (Part 1)

• Measurable disease as defined by RECIST 1.1 is required (Part 1B and Part 2 only)

Exclusion criteria

• Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases
• Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
• Major surgery or radiation within 4 weeks prior to study entry
• Last anti-cancer treatment within 2 weeks prior to study entry
• Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
• Pregnant or breastfeeding female patients
• Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastro intestinal function or GI disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

155 participants in 8 patient groups

Dose Escalation

Experimental group

Description:

Single Agent Dose Escalation

Treatment:

Drug: PF-06873600

Dose Finding Endocrine Therapy 1 Combination

Experimental group

Description:

Part 1B PF-06873600 plus Endocrine Therapy 1

Treatment:

Drug: PF-06873600

Drug: Endocrine Therapy 1

Dose Finding Endocrine Therapy 2 Combination

Experimental group

Description:

Part 1B PF-06873600 plus Endocrine Therapy 2

Treatment:

Drug: Endocrine Therapy 2

Drug: PF-06873600

Dose Expansion Arm A

Experimental group

Description:

PF-06873600 as a Single Agent

Treatment:

Drug: PF-06873600

Dose Expansion Arm B

Experimental group

Description:

PF-06873600 as a Single Agent in Various Tumor Types

Treatment:

Drug: PF-06873600

Dose Expansion Arm C

Experimental group

Description:

PF-06873600 in Combination with Endocrine Therapy 1

Treatment:

Drug: PF-06873600

Drug: Endocrine Therapy 1

Dose Expansion Arm D

Experimental group

Description:

PF-06873600 in Combination with Endocrine Therapy 1

Treatment:

Drug: PF-06873600

Drug: Endocrine Therapy 1

Dose Expansion Arm E

Experimental group

Description:

PF-06873600 in Combination with Endocrine Therapy 2

Treatment:

Drug: Endocrine Therapy 2

Drug: PF-06873600