PF-06821497 Treatment Of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma
Lung Cancer
Prostate Cancer
18 Years and older, Male and Female
C2321001 (primary)
NCI-2018-01985
Summary
A Phase 1 Dose Escalation and Expanded Cohort Study Of PF-06821497 In The Treatment Of
Adult Patients With Relapsed/Refractory Small Cell Lung Cancer (SCLC), Castration
Resistant Prostate Cancer (CRPC) And Follicular Lymphoma (FL).
Objectives
This is an open label, multi center, Phase 1 dose escalation and dose expansion study of
PF-06821497 administered orally BID as a single agent or in combination with SOC to
patients with CRPC, SCLC, and FL. Part 1A will evaluate safety and target modulation of
PF-06821497 monotherapy in patients with SCLC, FL and CRPC. PF-06821497 will be
administered as monotherapy in patients with FL in Part 1B dose escalation and to
patients with CRPC in Part 1C dose escalation. For Part 2A (dose escalation combination
therapy), PF-06821497 will be administered in combination with SOC in patients with CRPC
and SCLC. For Part 2B (dose expansion), patients with mCRPC will be randomized (1:1
ratio) to receive either SOC or PF-06821497 in combination with SOC. Once safety and
adequate target modulation has been established in Part 1A, Parts 1B and 2A of the trial
will be initiated. Part 1C (monotherapy dose escalation) will determine the MTD of single
agent PF-06821497 in patients with mCRPC. Japan and China monotherapy cohorts will
evaluate the safety, antitumor activity and PK of single agent PF-06821497 in Japanese
and Chinese patients. Part 2A (escalation RP2D finding for combination) will determine
the MTD of the combination with SOC in patients with CRPC. Part 2B (dose expansion) will
assess the efficacy of PF-06821497 at the RP2D in combination with SOC in patients with
mCRPC in comparison to SOC alone. The study is currently enrolling Part 2B.
Eligibility
- Key Inclusion Criteria:
Histological or cytological diagnosis of advanced / metastatic solid tumor with the
following tumor types in individual study parts:
Part 1A (closed to enrollment):
Part 1B (closed to enrollment):
Part 1C:
- Castration resistant prostate cancer. Patients should have received either
abiraterone and/or enzalutamide treatment and have evidence of prostate cancer
progression (per PCWG3) Japan cohort
- Castration resistant prostate cancer that is resistant to SOC or for which no local
regulatory approved SOC is available that would confer significant clinical benefit
in the medical judgement of the investigator. Patients should have received either
abiraterone and/or enzalutamide treatment and have evidence of prostate cancer
progression (per PCWG3) China cohort
- Castration resistant prostate cancer that is intolerant/resistant to SOC or for
which no local regulatory approved SOC is available that would confer significant
clinical benefit in the medical judgement of the investigator. Patients who refused
SOC may be eligible. Patients should have received either abiraterone and/or
enzalutamide treatment and have evidence of prostate cancer progression (per PCWG3)
Part 2A:
â?¢ Castration resistant prostate cancer. Patients should have received either abiraterone
and/or enzalutamide treatment, may have received up to 1 line of chemotherapy and have
evidence of prostate cancer progression (per PCWG3)
Part 2B:
- Castration resistant prostate cancer. Patients should have received abiraterone
treatment, may have received up to 1 prior line of chemotherapy, have not received
prior enzalutamide, apalutamide or darolutamide and have evidence of prostate cancer
progression (per PCWG3)
- Patients must have radiographic evidence of disease
Other inclusion criteria:
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
- Adequate organ function
Key Exclusion Criteria:
- Prior Chemotherapy: Part 1C , Japan cohort and China cohort (CRPC): no more than 2
previous regimens of chemotherapy Part 2A: CRPC: no more than 1 previous regimen of
systemic chemotherapy Part 2B (CRPC): no more than 1 previous regimen of
chemotherapy
- Prior irradiation to >25% of the bone marrow.
- QTcF interval >480 msec at screening.
- Hypertension that cannot be controlled by medications (>150/90 mmHg despite optimal
medical therapy).
- Known or suspected hypersensitivity to PF 06821497 or any components or enzalutamide
(CRPC)
- Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular
disease or previous gastric resection or lap band surgery. Gastroesophageal reflux
disease under treatment with proton pump inhibitors is allowed.
- Current use or anticipated need for food or drugs that are known strong CYP3A4/5
inducers or inhibitors, including their administration within 10 days or 5 half
lives of the CYP3A4/5 inhibitor, whichever is longer prior to first dose of
investigational product.
Treatment Sites in Georgia
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