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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).

Last updated on September 10, 2019

FOR MORE INFORMATION
Study Location
State Budgetary Healthcare Institution of the Yaroslavl Region
Yaroslavl, , 150054 Russian Federation
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Small Cell Lung Cancer (SCLC), Follicular Lymphoma (FL), Castration Resistant Prostate Cancer (CRPC), Diffuse Large B-Cell Lymphoma (DLBCL)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Part 1A:Histologically / cytologically confirmed advanced/unresectable or metastatic SCLC, CRPC,
DLBCL and FL that is refractory to or intolerable of SOC, or for which SOC is unavailable.
Note for FL (Parts 1A and 1B) during the dose finding phase of study, follicular lymphoma
patients must have exhausted all standard of care therapies.


Part 1B
:

Histologically confirmed FL patients that have exhausted all standard of care therapies and
have relapsed or refractory disease.


Part 2
:

-Histologically or cytologically confirmed treatment naïve extensive disease SCLC
patients;

- Histologically confirmed FL patients that have exhausted all standard of care
therapies and have relapsed or refractory disease (Part 2B).

- Histological / cytological diagnosis of castration resistant prostate cancer. Received
either abiraterone and/or enzalutamide treatment (chemotherapy naïve ) and has
evidence of prostate cancer progression (per PWG3):

- SCLC patients entering the study in the expansion cohort with at least one
measurable lesion as defined by Response Evaluation Criteria in Solid Tumors
(RECIST) version 1.1.

- FL patients entering the study in the expansion cohort with at least one
measurable lesion as defined by Response Evaluation Criteria in Lymphoma (RECIL)
criteria.

- Females and/or male patients age 18 years.

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.

- Adequate Bone Marrow Function

- Adequate Renal Function

- Adequate Liver Function

- Serum pregnancy test (for females of childbearing potential) negative at
screening, and negative serum or urine pregnancy test at baseline prior to
treatment administration.


Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Known symptomatic brain metastases requiring steroids or CNS involvement in FL.
Previously diagnosed brain metastases are eligible if they have been treated and
recovered from the acute effects of radiation therapy or surgery prior to study entry,
have discontinued corticosteroid treatment for these metastases for at least 4 weeks
and are neurologically stable.

- At least 3 weeks since last major surgery (a lesser period is acceptable if decided to
be in the best interest of the SCLC patient).

- Radiation therapy within 4 weeks prior to study entry. Note, patients who have
received radiotherapy must have recovered from any reversible side effects, such as
nausea and vomiting.

- Last systemic anti cancer chemotherapy or small molecule inhibitor treatment within 4
weeks prior to Cycle 1 Day 1, within 2 weeks if prior monoclonal antibody therapy was
included. Prostate cancer cohorts must be chemotherapy naïve.

- Last anti hormonal therapy within 2 weeks prior to C1D1.

- Prior allogenic stem cell transplant (ASCT).

- Prior irradiation to >25% of the bone marrow (see Appendix for Bone Marrow Reserve in
Adults).

- Active and clinically significant bacterial, fungal, or viral infection, including
hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus
(HIV) or acquired immunodeficiency syndrome (AIDS) related illness.

- Any of the following in the previous 6 months: myocardial infarction, congenital long
QT syndrome, Torsades de pointes, arrhythmias (including sustained ventricular
tachyarrhythmia and ventricular fibrillation), right bundle branch block and left
anterior hemiblock (bifascicular block), unstable angina, coronary/peripheral artery
bypass graft, symptomatic congestive heart failure (New York Heart Association class
III or IV), cerebrovascular accident, transient ischemic attack, or symptomatic
pulmonary embolism; ongoing cardiac dysrhythmias of NCI CTCAE Grade 2, atrial
fibrillation of any grade, or QTcF interval >480 msec at screening.

- Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal
medical therapy).

- Participation in other studies involving investigational drug(s) within 28 days or 5
half lives of the investigational drug(s) (whichever is longer, excluding monoclonal
antibodies which require a washout of 2 weeks) prior to study entry.

- Known or suspected hypersensitivity to PF 06821497 or any components or enzalutamide
(CRPC) or platinum compound.

- Other acute or chronic medical or psychiatric condition, including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the patient inappropriate for entry into this
study.

- Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
patients who are Pfizer employees, including their family members, directly involved
in the conduct of the study.

- Pregnant female patients; breastfeeding female patients; fertile male patients and
female patients of childbearing potential who are unwilling or unable to use 2 highly
effective methods of contraception as outlined in this protocol for the duration of
the study and for at least 28days after the last dose of investigational product.

- 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
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.

- Current use or anticipated need for drugs that are known strong CYP3A4/5 inducers,
including their administration within 10 days or 5 half lives of the CYP3A4/5 inducer,
whichever is longer prior to the first dose of investigational product.

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Tablets
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
A placebo is not used in this trial
Duration
The time commitment for participation in the study.
Follow up: Estimated 4 weeks
Screening: Range 0 days
Treatment: At least 24 weeks
Site Visits
Follow up: At least 1 visits
Screening: Estimated 3 visits
Treatment: At least 9 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Not planned
NCT03460977
Pfizer
Recruiting
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).

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