NADIR: Niraparib With Standard Combination Radiation Therapy and Androgen Deprivation Therapy in Treating Patients With High Risk Prostate Cancer

Sponsor
NRG Oncology (Other)
Overall Status
Suspended
CT.gov ID
NCT04037254
Collaborator
National Cancer Institute (NCI) (NIH)
180
87
3
115
2.1
0

Study Details

Study Description

Brief Summary

This phase II trial studies the side effects and best dose of niraparib, and to see how well it works in combination with standard of care radiation therapy and hormonal therapy (androgen deprivation therapy) in treating patients with prostate cancer that has a high chance of coming back (high risk). Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding niraparib to the usual treatments of radiation therapy and hormonal therapy may lower the chance of prostate cancer growing or returning.

Condition or Disease Intervention/Treatment Phase
  • Biological: Gonadotrophin Releasing Hormone
  • Radiation: Intensity-Modulated Radiation Therapy
  • Drug: Niraparib
Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. To establish the preferred dose of niraparib in combination with radiation and antiandrogen therapy (ADT). (Phase I) II. To compare the disease-free state, defined as PSA remaining < 0.1 ng/ml at the end of ADT therapy in men with high risk prostate cancer treated with standard therapy with or without the addition of niraparib. (Phase IIR)
SECONDARY OBJECTIVES:
  1. To further establish the safety and toxicity profile of standard treatment with radiation and androgen deprivation therapy specifically, two years from initiation of ADT, plus niraparib at the phase II dose.

  2. To compare the overall survival, prostate cancer-specific survival, local/regional or distant progression, and distant metastatic disease rates of standard therapy with or without the addition of niraparib.

EXPLORATORY OBJECTIVES:
  1. To identify genomic biomarkers of response to combination therapy with radiation, ADT and PARP inhibition.

OUTLINE: This is a phase I, dose-escalation study of niraparib, followed by a phase II study.

PHASE I: Patients receive niraparib orally (PO) once daily (QD) and receive standard of care gonadotrophin releasing hormone (GnRH) agonist androgen suppression therapy. Treatment with niraparib continues for 12 months, and GnRH agonist therapy for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib and GnRH agonist, patients undergo standard of care intensity-modulated radiation therapy (IMRT) 5 days per week for about 6-9 weeks, depending on type of radiation therapy given, in the absence of disease progression or unacceptable toxicity.

PHASE II: Patients are randomized to 1 of 2 arms:

ARM I: Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 8-28 weeks after starting GnRH agonist, patients undergo IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months, and niraparib PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 3 years, then annually for 3 years.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Phase II Trial of Niraparib With Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (With Initial Phase I)
Actual Study Start Date :
Jun 3, 2019
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phase I (niraparib, GnRH, IMRT)

Patients receive niraparib PO QD and receive standard of care GnRH agonist androgen suppression therapy. Treatment with niraparib continues for 12 months, and GnRH agonist therapy for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib and GnRH agonist, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks, depending on type of radiation therapy given, in the absence of disease progression or unacceptable toxicity.

Biological: Gonadotrophin Releasing Hormone
Receive standard of care GnRH agonist androgen suppression therapy
Other Names:
  • AY-24031
  • D-His-6-Pro-8-NEt-LHRH
  • Follicle Stimulating Hormone-Releasing Factor
  • GN-RH
  • GnRH
  • Gonadoliberin
  • Gonadorelin
  • Gonadorelinum
  • gonadotropin-releasing hormone
  • Hoe- 471
  • LH-RF
  • LH-RH
  • LH/FSH-RF
  • LH/FSH-RH
  • LHRH
  • Luliberin
  • Luteinising Hormone-Releasing Factor
  • Luteinizing Hormone-Releasing Factor
  • luteinizing hormone-releasing hormone
  • Radiation: Intensity-Modulated Radiation Therapy
    Undergo standard of care IMRT
    Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
  • Drug: Niraparib
    Given PO
    Other Names:
  • MK-4827
  • MK4827
  • Active Comparator: Phase II, Arm I (GnRH, IMRT)

    Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 8-28 weeks after starting GnRH agonist, patients undergo IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity.

    Biological: Gonadotrophin Releasing Hormone
    Receive standard of care GnRH agonist androgen suppression therapy
    Other Names:
  • AY-24031
  • D-His-6-Pro-8-NEt-LHRH
  • Follicle Stimulating Hormone-Releasing Factor
  • GN-RH
  • GnRH
  • Gonadoliberin
  • Gonadorelin
  • Gonadorelinum
  • gonadotropin-releasing hormone
  • Hoe- 471
  • LH-RF
  • LH-RH
  • LH/FSH-RF
  • LH/FSH-RH
  • LHRH
  • Luliberin
  • Luteinising Hormone-Releasing Factor
  • Luteinizing Hormone-Releasing Factor
  • luteinizing hormone-releasing hormone
  • Radiation: Intensity-Modulated Radiation Therapy
    Undergo standard of care IMRT
    Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
  • Experimental: Phase II, Arm II (niraparib, GnRH, IMRT)

    Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months, and niraparib PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity.

    Biological: Gonadotrophin Releasing Hormone
    Receive standard of care GnRH agonist androgen suppression therapy
    Other Names:
  • AY-24031
  • D-His-6-Pro-8-NEt-LHRH
  • Follicle Stimulating Hormone-Releasing Factor
  • GN-RH
  • GnRH
  • Gonadoliberin
  • Gonadorelin
  • Gonadorelinum
  • gonadotropin-releasing hormone
  • Hoe- 471
  • LH-RF
  • LH-RH
  • LH/FSH-RF
  • LH/FSH-RH
  • LHRH
  • Luliberin
  • Luteinising Hormone-Releasing Factor
  • Luteinizing Hormone-Releasing Factor
  • luteinizing hormone-releasing hormone
  • Radiation: Intensity-Modulated Radiation Therapy
    Undergo standard of care IMRT
    Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
  • Drug: Niraparib
    Given PO
    Other Names:
  • MK-4827
  • MK4827
  • Outcome Measures

    Primary Outcome Measures

    1. Maintenance of disease-free state [Up to 2 years following the start of antiandrogen therapy]

      Will be characterized by PSA values sustained below 0.1 ng/ml. A modified intent-to-treat analysis will be conducted. The proportion of patients disease-free at 24 months will be compared in the two treatment arms using a non continuity-corrected chi-square test. As a secondary analysis, a logistic regression model will be fit to adjust for the stratification factors (risk group and type of radiation therapy).

    Secondary Outcome Measures

    1. Overall Survival [From randomization until death from any cause, assessed up to 3 years]

      Will consist of comparison of Kaplan-Meier (Kaplan 1958) curves using a logrank test.

    2. Prostate cancer-specific survival [From randomization until death from prostate cancer, assessed up to 3 years]

      Will consist of comparison of Kaplan-Meier (Kaplan 1958) curves using a logrank test.

    3. Pathologic Complete Response (pCR) [At 24 months]

      Will be assessed among patients undergoing 12-core biopsy. Will be compared using a chi-square test.

    4. Time to local/regional or distant progression [Up to 3 years]

      Cumulative incidence curves will be compared using the Fine-Gray test (Dignam 2008).

    5. Time to distant metastases [From randomization until detection of distant metastatic disease, assessed up to 3 years]

      Cumulative incidence curves will be compared using the Fine-Gray test (Dignam 2008).

    6. Biochemical Progression-Free Survival [Up to 3 years]

      Will be defined as PSA >= 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or death from prostate cancer. Will consist of comparison of Kaplan-Meier (Kaplan 1958) curves using a logrank test.

    7. Incidence of Adverse Events (Phase II) [Up to 3 years]

      Adverse event (AE) rates in the two treatment arms will be summarized by time of occurrence (early versus late), type, grade, and attribution to treatment. For each type of AE, the worst grade occurring during the early treatment period, late treatment period, or entire treatment period will be determined. For each time period, treatment group comparisons will be conducted using chi-square or Fisher exact tests.

    Other Outcome Measures

    1. Exome sequencing of deoxyribonucleic acid (DNA) repair genes and detected alterations [Up to 3 years]

      Descriptive statistics will be generated summarizing the frequency of gene alterations, mutations, and gene expression levels. The percentage of patients with baseline or post-therapy alterations in targeted genes will be reported and the association between the occurrence of reversion mutations in DNA repair genes and clinical outcomes will be assessed using logistic regression models for dichotomous endpoints (disease-free state, pCR), and Cox regression or competing risk regression modeling for time-to-event data.

    2. Transcription-wide analysis of gene expression [Up to 3 years]

      Will be assessed using a high-density Affymetrix oligonucleotide array to profile the transcriptome of tumor samples. Descriptive statistics will be generated summarizing the frequency of gene alterations, mutations, and gene expression levels. The percentage of patients with baseline or post-therapy alterations in targeted genes will be reported and the association between the occurrence of reversion mutations in DNA repair genes and clinical outcomes will be assessed using logistic regression models for dichotomous endpoints (disease-free state, pCR), and Cox regression or competing risk regression modeling for time-to-event data.

    3. Single nucleotide polymorphisms [Up to 3 years]

      Will be analyzed in whole blood samples previously associated with prostate risk. Plasma samples will be assessed for baseline and post-therapy alterations in a targeted gene panel and for reversion mutations in DNA repair genes as early biomarkers of treatment resistance. Descriptive statistics will be generated summarizing the frequency of gene alterations, mutations, and gene expression levels. The percentage of patients with baseline or post-therapy alterations in targeted genes will be reported and the association between the occurrence of reversion mutations in DNA repair genes and clinical outcomes will be assessed using logistic regression models for dichotomous endpoints (disease-free state, pCR), and Cox regression or competing risk regression modeling for time-to-event data.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Histologically confirmed (within 180 days prior to registration) adenocarcinoma of the prostate at high risk for recurrence as determined by the following criteria, according to American Joint Committee on Cancer (AJCC) 8th edition:

    • Phase I enrollment

    • Gleason >= 9, PSA =< 150 ng/mL, any T-stage

    • Phase II enrollment

    • Gleason >= 9, PSA =< 150 ng/mL, any T-stage

    • Gleason 8, PSA < 20 ng/mL, and >= T2

    • Gleason 8, PSA >= 20-150 ng/mL, any T-stage

    • Gleason 7, PSA >= 20-150 ng/mL, any T-stage

    • No distant metastases as evaluated by:

    • Bone scan 90 days prior to registration

    • Lymph node assessment by computed tomography (CT) or magnetic resonance (MR) of pelvis or nodal sampling within 90 days prior to registration (Please note: Lymph nodes will be considered negative (N0) if they are < 1.5 cm short axis)

    • History/physical examination within 90 days prior to registration

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 180 days prior to registration

    • Pretreatment serum PSA, obtained prior to any androgen suppression therapy and within 180 days of registration

    • Phase I patients: Prior androgen suppression for prostate cancer is not allowed prior to registration

    • Phase II patients: Prior androgen suppression for prostate cancer is allowed =< 45 days prior to registration

    • Hemoglobin >= 9.0 g/dL (within 90 days prior to registration)

    • Platelets >= 100,000 cells/mm^3 (within 90 days prior to registration)

    • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (within 90 days prior to registration)

    • Serum creatinine =<1.5 x upper limit of normal (ULN) OR a calculated creatinine clearance >= 30 mL/min estimated using Cockcroft-Gault equation (within 90 days prior to registration)

    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN (within 90 days prior to registration)

    • Serum albumin >= 3 g/dL (within 90 days prior to registration)

    • Serum potassium >= 3.5 mg/dL (within 90 days prior to registration)

    • Serum total bilirubin =< 1.5 x ULN or direct bilirubin =< 1 x ULN (Note: in subjects with Gilberts syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin, and if direct bilirubin is =< 1.5 x ULN, subject may be eligible) (within 90 days prior to registration)

    • Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards

    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

    Exclusion Criteria:
    • PSA > 150 ng/mL

    • Definitive clinical or radiologic evidence of metastatic disease

    • Pathologically positive lymph nodes or nodes > 1.5 cm short axis on CT or MR imaging

    • Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason

    • Any active malignancy within 2 years of study registration that may alter the course of prostate cancer treatment.

    • Prior systemic therapy for prostate cancer; note that prior therapy for a different cancer is allowable

    • Prior radiotherapy, including brachytherapy, to the region of the prostate that would result in overlap of radiation therapy fields

    • Current treatment with first generation anti-androgens (bicalutamide, nilutamide, flutamide). For patients enrolled to phase II, if prior anti-androgens were administered, a washout period of >= 30 days is required prior to enrollment

    • Severe, active co-morbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

    • Transmural myocardial infarction within the last 6 months

    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

    • Uncontrolled acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition

    • Presence of uncontrolled hypertension (persistent systolic blood pressure [BP]

    =160 mmHg or diastolic BP >= 100 mmHg). Subjects with a history of hypertension are allowed, provided that BP is controlled to within these limits by anti-hypertensive treatment

    • Prior allergic reaction to the drugs involved in this protocol (including known allergies, hypersensitivity or intolerance to the excipients of niraparib. Please see Niraparib IB for details.)

    • Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter

    • Note that patients who are HIV positive are eligible, provided they have a CD4 count >= 200 cells/microliter within 90 days prior to registration. Patients receiving treatment with highly active antiretroviral therapy (HAART) will not be eligible due to concern for radiosensitization

    • Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be affected by these drugs.

    • Any history or current diagnosis of Myelodysplasitc Syndromes (MDS)/ Acute Myeloid Leukemia (AML).

    • Prior or current treatment with PARP inhibitor

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner MD Anderson Cancer Center Gilbert Arizona United States 85234
    2 University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona United States 85704
    3 University of Arizona Cancer Center-North Campus Tucson Arizona United States 85719
    4 City of Hope Comprehensive Cancer Center Duarte California United States 91010
    5 Cedars Sinai Medical Center Los Angeles California United States 90048
    6 Fremont - Rideout Cancer Center Marysville California United States 95901
    7 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    8 City of Hope Upland Upland California United States 91786
    9 George Washington University Medical Center Washington District of Columbia United States 20037
    10 Grady Health System Atlanta Georgia United States 30303
    11 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
    12 Emory Saint Joseph's Hospital Atlanta Georgia United States 30342
    13 CTCA at Southeastern Regional Medical Center Newnan Georgia United States 30265
    14 Northwestern University Chicago Illinois United States 60611
    15 Rush University Medical Center Chicago Illinois United States 60612
    16 Carle Cancer Center Urbana Illinois United States 61801
    17 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
    18 University of Kansas Cancer Center Kansas City Kansas United States 66160
    19 University of Kansas Cancer Center-Overland Park Overland Park Kansas United States 66210
    20 University of Kansas Hospital-Westwood Cancer Center Westwood Kansas United States 66205
    21 University of Maryland/Greenebaum Cancer Center Baltimore Maryland United States 21201
    22 Central Maryland Radiation Oncology in Howard County Columbia Maryland United States 21044
    23 UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie Maryland United States 21061
    24 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    25 McLaren Cancer Institute-Bay City Bay City Michigan United States 48706
    26 Henry Ford Cancer Institute-Downriver Brownstown Michigan United States 48183
    27 McLaren Cancer Institute-Clarkston Clarkston Michigan United States 48346
    28 Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan United States 48038
    29 Henry Ford Medical Center-Fairlane Dearborn Michigan United States 48126
    30 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
    31 Henry Ford Hospital Detroit Michigan United States 48202
    32 Weisberg Cancer Treatment Center Farmington Hills Michigan United States 48334
    33 McLaren Cancer Institute-Flint Flint Michigan United States 48532
    34 Singh and Arora Hematology Oncology PC Flint Michigan United States 48532
    35 Karmanos Cancer Institute at McLaren Greater Lansing Lansing Michigan United States 48910
    36 Mid-Michigan Physicians-Lansing Lansing Michigan United States 48912
    37 McLaren Cancer Institute-Lapeer Region Lapeer Michigan United States 48446
    38 McLaren Cancer Institute-Macomb Mount Clemens Michigan United States 48043
    39 Henry Ford Medical Center-Columbus Novi Michigan United States 48377
    40 McLaren Cancer Institute-Northern Michigan Petoskey Michigan United States 49770
    41 McLaren-Port Huron Port Huron Michigan United States 48060
    42 Henry Ford Macomb Health Center - Shelby Township Shelby Michigan United States 48315
    43 Henry Ford West Bloomfield Hospital West Bloomfield Michigan United States 48322
    44 University of Mississippi Medical Center Jackson Mississippi United States 39216
    45 Siteman Cancer Center at West County Hospital Creve Coeur Missouri United States 63141
    46 University of Kansas Cancer Center - North Kansas City Missouri United States 64154
    47 University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri United States 64064
    48 Washington University School of Medicine Saint Louis Missouri United States 63110
    49 Siteman Cancer Center-South County Saint Louis Missouri United States 63129
    50 Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri United States 63376
    51 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    52 AtlantiCare Health Park-Cape May Court House Cape May Court House New Jersey United States 08210
    53 AtlantiCare Surgery Center Egg Harbor Township New Jersey United States 08234
    54 Rutgers New Jersey Medical School Newark New Jersey United States 07101
    55 Holy Name Hospital Teaneck New Jersey United States 07666
    56 Roswell Park Cancer Institute Buffalo New York United States 14263
    57 The New York Hospital Medical Center of Queens Flushing New York United States 11355
    58 Highland Hospital Rochester New York United States 14620
    59 University of Rochester Rochester New York United States 14642
    60 Stony Brook University Medical Center Stony Brook New York United States 11794
    61 Summa Health System - Akron Campus Akron Ohio United States 44304
    62 Summa Health System - Barberton Campus Barberton Ohio United States 44203
    63 University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio United States 45219
    64 Case Western Reserve University Cleveland Ohio United States 44106
    65 University of Cincinnati Cancer Center-West Chester West Chester Ohio United States 45069
    66 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    67 Geisinger Medical Center Danville Pennsylvania United States 17822
    68 Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania United States 17837
    69 Lewistown Hospital Lewistown Pennsylvania United States 17044
    70 Eastern Regional Medical Center Philadelphia Pennsylvania United States 19124
    71 UPMC-Shadyside Hospital Pittsburgh Pennsylvania United States 15232
    72 Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania United States 18711
    73 Medical University of South Carolina Charleston South Carolina United States 29425
    74 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
    75 Saint Francis Cancer Center Greenville South Carolina United States 29607
    76 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
    77 Self Regional Healthcare Greenwood South Carolina United States 29646
    78 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
    79 Prisma Health Cancer Institute - Seneca Seneca South Carolina United States 29672
    80 West Virginia University Healthcare Morgantown West Virginia United States 26506
    81 Froedtert Menomonee Falls Hospital Menomonee Falls Wisconsin United States 53051
    82 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    83 Zablocki Veterans Administration Medical Center Milwaukee Wisconsin United States 53295
    84 Drexel Town Square Health Center Oak Creek Wisconsin United States 53154
    85 ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin United States 53066
    86 UW Cancer Center at ProHealth Care Waukesha Wisconsin United States 53188
    87 Froedtert West Bend Hospital/Kraemer Cancer Center West Bend Wisconsin United States 53095

    Sponsors and Collaborators

    • NRG Oncology
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: M. D Michaelson, NRG Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NRG Oncology
    ClinicalTrials.gov Identifier:
    NCT04037254
    Other Study ID Numbers:
    • NRG-GU007
    • NCI-2019-02260
    • NRG-GU007
    • NRG-GU007
    • U10CA180868
    First Posted:
    Jul 30, 2019
    Last Update Posted:
    Jul 14, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 14, 2022