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PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03685591
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
A Phase 1 dose escalation study evaluating safety, tolerability and pharmacokinetics of PF-06952229 in adult patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Hormone Receptor Positive Advanced Breast Cancer Metastatic Breast Cancer Human Epidermal Receptor 2 Negative Advanced Breast Cancer Castration Resistant Prostate Cancer Drug: PF-06952229 Drug: Palbociclib Drug: Letrozole Drug: Enzalutamide Phase 1

Detailed Description:

This is a Phase 1, open label, multi center, multiple dose, dose escalation and expansion, safety, tolerability, PK, and pharmacodynamics study of PF 06952229 in previously treated patients with advanced or metastatic cancer that is known to have high TGFbeta signatures and EMT expression.

This trial includes 2 parts. Part 1 is a a monotherapy dose escalation phase and Part 2 arms A and B is the dose escalation expansion phase. Part 2 Arm A combines PF-06952229 with palbociclib and letrozole in HR+HER advanced or metastatic breast cancer. Part 2 Arm B combines PF-06952229 with enzalutamide in castration resistant prostate cancer (CRPC).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 1 DOSE ESCALATION STUDY EVALUATING SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06952229 IN ADULT PATIENTS WITH ADVANCED SOLID TUMORS
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : December 9, 2022
Estimated Study Completion Date : August 28, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose Level 1
PF-06952229 at 20mg twice daily (BID)
Drug: PF-06952229
Oral 7 days on / 7 days off - 28 day cycles (Part 1)

Experimental: Dose Level 2
PF-06952229 at 40 mg BID
Drug: PF-06952229
Oral 7 days on / 7 days off - 28 day cycles (Part 1)

Experimental: Dose Level 3
PF-06952229 at 80 mg BID
Drug: PF-06952229
Oral 7 days on / 7 days off - 28 day cycles (Part 1)

Experimental: Dose Level 4
PF-06952229 at 150 mg BID
Drug: PF-06952229
Oral 7 days on / 7 days off - 28 day cycles (Part 1)

Experimental: Dose Level 5
PF-06952229 at 250 mg BID
Drug: PF-06952229
Oral 7 days on / 7 days off - 28 day cycles (Part 1)

Experimental: Dose Level 6
PF-06952229 at 375 mg BID
Drug: PF-06952229
Oral 7 days on / 7 days off - 28 day cycles (Part 1)

Experimental: Dose Level 7
PF-06952229 at 500 mg BID
Drug: PF-06952229
Oral 7 days on / 7 days off - 28 day cycles (Part 1)

Experimental: Dose Level 8
PF-06952229 at 625 mg BID
Drug: PF-06952229
Oral 7 days on / 7 days off - 28 day cycles (Part 1)

Experimental: Breast Cancer (Part 2)
PF-06952229 at recommended part 2 dose (RP2D) in combination with palbociclib and letrozole
Drug: Palbociclib
Breast Cancer (Part 2). 125mg, capsules, orally, once daily for 21 days followed by 7 days off.

Drug: Letrozole
Breast Cancer (Part 2). 2.5mg, tablets, orally, daily.

Experimental: Prostate Cancer Part 2
PF-06952229 at recommended part 2 dose (RP2D) in combination with enzalutamide
Drug: Enzalutamide
Prostate Cancer (Part 2). 160mg, capsules, orally, daily




Primary Outcome Measures :
  1. Percentage of patients with dose limiting toxicities to determine maximum tolerated dose/recommended Phase 2 dose [ Time Frame: Baseline up to 90 days ]
    First cycle DLTs will be utilized to determine the max tolerated dose and future escalations or deescalations. A DLT is any of the predefined set of unacceptable adverse events observed and at least possibly related to investigational agents.

  2. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: Baseline up to 28 days post last dose of study treatment ( up to approximately 2 years) ]
    Treatment-related AE is any untoward medical occurrence attributed to study drug in a participant who received study drug.

  3. Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities [ Time Frame: Baseline up to 28 days post last dose of study treatment ( up to approximately 2 years) ]
    Laboratory parameters may include: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). Clinical significance of laboratory parameters was determined at the investigator's discretion.

  4. Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: Baseline up to 28 days post last dose of study treatment ( up to approximately 2 years) ]
  5. Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings [ Time Frame: Baseline up to 28 days post last dose of study treatment ( up to approximately 2 years) ]
    Criteria for potentially clinically important (PCI) changes in ECG (12-lead) were defined as: no sinus rhythm; PR interval >=220 msec and increase of >=20 msec; QRS interval >=120 msec; QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB) >500 msec or increase of >60 msec; heart rate <=45 beats per minute (bpm) or >=120 bpm or decrease/increase of >=15 bpm.


Secondary Outcome Measures :
  1. Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax) as a single agent in Part 1 and in combination in Part 2 [ Time Frame: Cycle 1 Day 1, Day 7 and Cycle 2 Day 1, Predose, 0.5, 1, 2, 4, 6, and 12 hours post dose, pre dose on Cycle 1 Day 15, Cycle 2 Day 7, and Cycle 3 and higher Day 7, and End of Treatment ]
    Single dose and multiple dose PK will be calculated as data permits including Maximum Observed Plasma Concentration (Cmax).

  2. Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Cycle 1 Day 1, Day 7 and Cycle 2 Day 1, Predose, 0.5, 1, 2, 4, 6 and 12 hours post dose, pre dose on Cycle 1 Day 15, Cycle 2 Day 7, and Cycle 3 and higher Day 7, and End of Treatment ]
    Single dose and multiple dose PK will be calculated as data permits including Time to Reach Maximum Observed Plasma Concentration (Tmax).

  3. Pharmacokinetic Parameters: Area Under the Curve (AUC) [ Time Frame: Cycle 1 Day 1, Day 7 and Cycle 2 Day 1, Predose, 0.5, 1, 2, 4, 6 and 12 hours post dose, pre dose on Cycle 1 Day 15, Cycle 2 Day 7, and Cycle 3 and higher Day 7, and End of Treatment ]
    Single dose and multiple dose PK will be calculated as data permits including Area Under the Curve (AUC).

  4. Pharmacokinetic Parameters: Apparent Oral Clearance (CL/F) [ Time Frame: Cycle 1 Day 1, Day 7 and Cycle 2 Day 1, Predose, 0.5, 1, 2, 4, 6 and 12 hours post dose, pre dose on Cycle 1 Day 15, Cycle 2 Day 7, and Cycle 3 and higher Day 7, and End of Treatment ]
    Single dose and multiple dose PK will be calculated as data permits including Apparent Oral Clearance (CL/F). Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

  5. Pharmacokinetic Parameters: Apparent Volume of Distribution (Vz/F) [ Time Frame: Cycle 1 Day 1, Day 7 and Cycle 2 Day 1, Predose, 0.5, 1, 2, 4, 6 and 12 hours post dose, pre dose on Cycle 1 Day 15, Cycle 2 Day 7, and Cycle 3 and higher Day 7, and End of Treatment ]
    Single dose and multiple dose PK will be calculated as data permits including Apparent Volume of Distribution (Vz/F). Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

  6. Pharmacokinetic Parameters: Plasma Decay Half-Life (t1/2) [ Time Frame: Cycle 1 Day 1, Day 7 and Cycle 2 Day 1, Predose, 0.5, 1, 2, 4, 6 and 12 hours post dose, pre dose on Cycle 1 Day 15, Cycle 2 Day 7, and Cycle 3 and higher Day 7, and End of Treatment ]
    Single dose and multiple dose PK will be calculated as data permits including Plasma Decay Half-Life (t1/2). Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  7. Evaluate preliminary anti-tumor activity of PF-06952229 [ Time Frame: Baseline and every 8 to 12 weeks through time of confirmed disease progression, unacceptable toxicity, or through study completion, approximately 2 years. ]
    Response endpoints based on Response Evaluation Criteria in Solid Tumors 1.1 for solid tumors including HR+ HER2 negative Breast Cancer and Prostate Working Group 3 for Castration Resistant Prostate Cancer.

  8. Objective Response Rate (ORR) [ Time Frame: Baseline up to approximately 2 years ]
    Proportion of patients with a reduction in tumor burden as defined by RECIST 1.1. and PWG3 response criteria.

  9. Duration of Response (DOR) [ Time Frame: Baseline up to approximately 2 years ]
    Time of initial response until documented tumor progression.

  10. Progression free survival (PFS) [ Time Frame: Baseline up to approximately 2 years ]
    The time from Cycle 1 Day 1 dose administration to disease progression or death from any cause.

  11. Overall Survival (OS) [ Time Frame: Baseline up to approximately 2 years ]
    Time from Cycle 1 Day 1 until death from any cause.

  12. Time to Progression (TTP) [ Time Frame: Baseline up to approximately 2 years ]
    Time from Cycle 1 Day 1 until objective tumor progression.

  13. Time to Response (TTR) [ Time Frame: Baseline up to approximately 2 years ]
    Time from Cycle 1 Day 1 to objective tumor response.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Part 1: Histological or cytological diagnosis of a solid tumor that is advanced/metastatic, patients intolerant to standard treatment, resistant to standard therapy or for which no standard therapy is available.
  • Part 2: Arm A: Patients with histological or cytological proven diagnosis of adenocarcinoma of the breast (HR+ HER2 ) with evidence of either locally advanced disease not amenable to resection or radiation therapy with curative intent or metastatic disease not amenable to curative therapy.
  • Documentation of HR positive (ie, ER positive and/or progesterone receptor positive tumor, (>1% positive stained cells) and HER2 negative tumor (described above);
  • Have progressed on prior CDK4/6 inhibitor therapy;
  • Received greater than or equal to 2 prior lines of therapy in the metastatic setting;
  • Must have evaluable disease by RECIST v 1.1.
  • Arm B: Histological or cytological diagnosis of castration resistant prostate cancer (serum testosterone of less than 50 ng/dL). Received either abiraterone and/or enzalutamide treatment and has evidence of prostate cancer progression (per Prostate Cancer Working Group 3 Criteria for progression at trial entry): Elevated prostate specific antigen (PSA) only; Bone only metastasis and nodal disease (Escalation only); Nodal disease (no bone disease present);Visceral (lung, liver, adrenal, CNS) disease (other sites) (For Expansion measurable by RECIST 1.1 only).
  • Age greater than or equal to 18 years.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
  • Adequate bone marrow function, including: Absolute Neutrophil Count (ANC) greater than or equal to 1,500/mm3 or 1.5 x 109/L; Platelets greater than or equal to 100,000/mm3 or 100 x 109/L; Hemoglobin greater than or equal to 9 g/dL.
  • Adequate renal function, including serum creatinine less than or equal to1.5 x upper limit of normal (ULN) or estimated creatinine clearance greater than or equal to 60 mL/min as calculated using the method standard for the institution. In equivocal cases, a 24 hour urine collection test can be used to estimate the creatinine clearance more accurately. In Part 2: Serum creatinine of less than or equal to 3.0 x upper limit of normal.
  • Adequate liver function, including: Total serum bilirubin less than or equal to 1.5 x ULN unless the patient has documented Gilbert syndrome; Aspartate and alanine aminotransferase (AST and ALT) less than or equal to 2.5 x ULN, 5.0 x ULN if there is liver involvement by the tumor; Alkaline phosphatase less than or equal to 2.5 x ULN (less than or equal to 5 x ULN in case of bone metastasis).
  • Serum phosphate within normal range (if abnormal, must be not clinically significant per the Investigator and approval for patient inclusion after agreement from sponsor.
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE less than or equal to Grade 1 except for adverse events not constituting a safety risk by investigator judgment.
  • Serum pregnancy test (for females of childbearing potential) negative at screening.
  • Female patients of non-childbearing potential must meet at least 1 of the following criteria: Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and must have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state; Have undergone a documented hysterectomy and/or bilateral oophorectomy; Have medically confirmed ovarian failure. All other female patients (including female patients with tubal ligations) are considered to be of childbearing potential.
  • Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures.

Exclusion Criteria:

  • Central Nervous System (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by baseline brain MRI (or CT with contrast if MRI is medically contraindicated), clinical symptoms, cerebral edema, and/or progressive growth. If contrast is medically contraindicated, a non-contrast CT scan may be performed.
  • Patients with a history of CNS metastases or cord compression.
  • Liver metastases at baseline as evidenced by CT scan or MRI that may be at risk for bleeding, such as those that are greater than 1cm.
  • Patients with advanced/metastatic, symptomatic, visceral spread, that are at risk of life threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement). Note: Patients with indwelling catheter for drainage, or requirement for drainage no more frequently than monthly will be allowed.
  • Any other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
  • History of clinically significant tumor bleeding (except for bleeding in a post operative setting), coagulopathy or arterio-venous malformations, or aneurysms in the CNS, liver, lung, or other major organ of the study. Patients with known Osler-Weber-Rendu disease, Hemophilia A, Hemophilia B (Christmas Disease), Von Willibrand's Disease, Factor 13 deficiency and Factor 7 deficiency, antibodies to Factors 8 and 7, history of other bleeding diatheses and abnormal INR values.
  • Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that in the opinion of the investigator is likely to bleed.
  • Major surgery within 4 weeks prior to first dose.
  • Prior organ transplantation including heart and allogeneic stem cell transplantation.
  • 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 anti cancer therapy including investigational drug(s) within 28 days (or 5 half lives, whichever is shorter) prior to study entry excluding hormonal therapy which requires no treatment free interval.
  • Active and clinically significant bacterial, fungal, or viral infection, including known hepatitis B virus (HBV), known hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness. In equivocal cases, with positive serology, those patients with a negative viral load are potentially eligible provided the other entry criteria are met. Note: Inclusion of patients with well controlled HIV, HBV or HCV can be discussed with sponsor on a case by case basis.
  • 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; deep venous thrombosis; arterial occlusive disease; ongoing cardiac dysrhythmias of National Cancer Institute (NCI) CTCAE Grade greater than or equal to 2, atrial fibrillation of any grade that is uncontrolled, or QTcF interval >470 msec at screening. Note: There is an exception where a cardiac rhythm device/pacemaker is fitted and results in QTcF >470 msec. -Anticoagulation therapy with heparin, low molecular weight heparin, vitamin K antagonists anti platelet agents, or factor Xa inhibitors throughout the study and for at least 28 days post the last dose of study treatment. (If anticoagulation therapy is medically indicated on trial, patients should stop treatment with PF-06952229. For those requiring temporary anticoagulant therapy, resumption of PF-06952229 treatment may be permitted after discussion with the Sponsor. In any other case, study treatment should be permanently discontinued, and the patient should enter the follow-up portion of the trial.)
  • Moderate or severe heart valve function defect including moderate or severe valve stenosis or regurgitation.
  • Evidence or history of septal aneurysm, other heart aneurysm, or any aneurysm of the major vessels.
  • Grade 3 or greater cardiac troponin I at baseline.
  • Left ventricular ejection fraction (LVEF) of less than or equal to 50% or significant valvular regurgitation.
  • Hypertension that cannot be controlled by medications (>150/90 mmHg despite optimal medical therapy) or requiring more than 2 medications for adequate control.
  • Clinically significant non healing or healing wounds.
  • For patients entering the combination with enzalutamide arm, history of seizures other than isolated febrile seizure in childhood;
  • Has a history of a cerebrovascular accident or transient ischemic attack less than 6 months ago.
  • Known or suspected hypersensitivity to active ingredient/excipients of PF-06952229, letrozole, palbociclib, or enzalutamide.
  • 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 28 days after the last dose of investigational product.
  • Inability to consume or absorb study drug, including but not limited to: Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery. Impairment of gastro intestinal function or GI disease that may significantly alter the absorption of PF 06952229, such as history of GI surgery with may result in intestinal blind loops and patients with clinically significant gastroparesis, short bowel syndrome, unresolved nausea, vomiting, active inflammatory bowel disease or diarrhea of CTCAE Grade >1.
  • Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors, including their administration within 5 half lives of the CYP3A4/5 inhibitor, prior to first dose of investigational product. Current or anticipated use of moderate CYP3A4/5 inhibitors (including their administration within 5 half lives of the CYP3A4/5 inhibitor, prior to first dose of investigational product) should be avoided if possible, and any use will need to be reviewed and approved by the sponsor.
  • Strong CYP3A4/5 inhibitors: eg, grapefruit juice or grapefruit/grapefruit related citrus fruits (eg, Seville oranges, pomelos), ketoconazole, miconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, amprenavir, fosamprenavir nefazodone, lopinavir, troleandomycin, mibefradil, and conivaptan. Current list can be found at Indiana University Purdue University Indianapolis.
  • Moderate CYP3A4/5 inhibitors: eg, erythromycin, verapamil, atazanavir, delavirdine, fluconazole, darunavir, diltiazem, aprepitant, imatinib, tofisopam, ciprofloxacin, and cimetidine. Current list can be found at Indiana University Purdue University Indianapolis.
  • Current use or anticipated need for drugs that are known strong CYP3A4/5 inducers, with the exception of enzalutamide in Part 2, including their administration within 4 weeks or 5 half lives of the CYP3A4/5 inducer, whichever is longer, prior to the first dose of investigational product. Strong CYP3A4/5 inducers: eg, phenobarbital, rifampin, phenytoin, carbamazepine, rifabutin, rifapentine, clevidipine, St. John's Wort.
  • Have initiated bisphosphonates or approved receptor activator of nuclear factor kappa B ligand (RANK L) targeted agents (for example, denosumab) <14 days prior to randomization.
  • Active, known or suspected autoimmune diseases including inflammatory bowel disease (including ulcerative colitis and Crohn's disease), rheumatoid arthritis, systemic progressive sclerosis, systemic lupus erythematosus (SLE), autoimmune vasculitis (eg, Wegener's Granulomatosis), CNS or motor neuropathy considered to be of autoimmune origin (eg, Guillain-Barre Syndrome, Myasthenia Gravis, Multiple Sclerosis).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685591


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, Arizona
Scottsdale Healthcare Hospitals dba HonorHealth Recruiting
Scottsdale, Arizona, United States, 85258
United States, California
UCLA Dept of Medicine -Hematology/Oncology,Santa Monica Active, not recruiting
Santa Monica, California, United States, 90404
United States, Oklahoma
OU Medical Center Presbyterian Tower Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
Stephenson Cancer Center Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37203
The Sarah Cannon Research Institute / Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03685591    
Other Study ID Numbers: C3881001
C3881001 ( Other Identifier: Alias Study Number )
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
efficacy
safety
pharmacokinetics
dose escalation
dose expansion
open-label
TGFb
transforming growth factor beta
breast cancer
prostate cancer
HR+
HER2 negative
CRPC
metastatic
advanced
adenocarcinoma
Additional relevant MeSH terms:
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Breast Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Letrozole
Palbociclib
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Protein Kinase Inhibitors