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Olaparib With or Without Cediranib in Treating Patients With Metastatic Castration-Resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02893917
Recruitment Status : Recruiting
First Posted : September 9, 2016
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This randomized phase II trial studies how well olaparib with or without cediranib works in treating patients with castration-resistant prostate cancer that has spread to other places in the body. Olaparib and cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Condition or disease Intervention/treatment Phase
Castration Levels of Testosterone Castration-Resistant Prostate Carcinoma Metastatic Prostate Carcinoma Prostate Adenocarcinoma With Focal Neuroendocrine Differentiation Prostate Carcinoma Metastatic in the Bone Prostate Small Cell Carcinoma PSA Progression Stage IV Prostate Adenocarcinoma AJCC v7 Drug: Cediranib Other: Laboratory Biomarker Analysis Drug: Olaparib Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the clinical activity of the combination of cediranib and olaparib, as measured by radiographic progression free survival (rPFS), as compared to olaparib monotherapy in patients with metastatic castration resistant prostate cancer (mCRPC).

SECONDARY OBJECTIVES:

I. To assess the clinical activity of the combination of cediranib and olaparib, as measured by prostate-specific antigen (PSA) response rate, radiographic response rate by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, and overall survival (OS), as compared to olaparib monotherapy in patients with mCRPC.

II. To evaluate association of homologous recombination deoxyribonucleic acid (DNA) repair deficiency (HRD) with the clinical activity of the combination of cediranib and olaparib or olaparib monotherapy, as measured by rPFS, in mCRPC patients.

III. To evaluate the safety the combination of cediranib and olaparib and olaparib monotherapy in patients with metastatic prostate cancer.

TERTIARY OBJECTIVES:

I. To characterize genomic alterations by whole exome sequencing in mCRPC patients and correlate that with clinical activity or resistance to olaparib with or without cediranib.

II. To characterize changes in ribonucleic acid (RNA) expression of DNA repair genes, angiogenesis markers, and immune markers, by whole transcriptome sequencing and correlate with clinical activity or resistance to olaparib with or without cediranib.

III. To characterize changes in immune tumor microenvironment in mCRPC patients by profiling expression of co-stimulatory and co-inhibitory molecules and tumor infiltrating lymphocytes, and correlate with clinical activity or resistance to olaparib with or without cediranib.

IV. To identify baseline predictive biomarkers for rPFS or response and to identify on-treatment markers of acquired resistance in men with mCRPC receiving either olaparib plus cediranib or olaparib alone.

V. To explore biomarker signatures that correlate with the clinical activity or resistance to olaparib with or without cediranib, including changes in gene expression or acquired mutations in tumor biopsies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive olaparib orally (PO) twice daily (BID) and cediranib PO once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive olaparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Study of Cediranib in Combination With Olaparib Versus Olaparib Alone in Men With Metastatic Castration Resistant Prostate Cancer
Actual Study Start Date : December 23, 2016
Estimated Primary Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Olaparib

Arm Intervention/treatment
Experimental: Arm A (olaparib, cediranib)
Patients receive olaparib PO BID and cediranib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Cediranib
Given PO
Other Name: AZD2171

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Olaparib
Given PO
Other Names:
  • AZD2281
  • KU-0059436
  • Lynparza
  • PARP Inhibitor AZD2281

Active Comparator: Arm B (olaparib)
Patients receive olaparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Olaparib
Given PO
Other Names:
  • AZD2281
  • KU-0059436
  • Lynparza
  • PARP Inhibitor AZD2281




Primary Outcome Measures :
  1. Radiographic progression free survival [ Time Frame: Time interval from random assignment to the date when the first site of disease is found to progress, or death, whichever occurs first, assessed up to 2 years ]
    The two study arms will be compared for radiographic progression free survival with Kaplan-Meier estimates and log-rank tests. The Rothman confidence interval, which is based on Greenwood's variance, Thomas and Grunkemeier confidence interval, and the simultaneous confidence bands by Nair and Hall and Wellner, will be reported. In addition, the possible risk factors will be compared for survival with log-rank test.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Time between randomization and death due to any cause (or last contact for surviving patients and those lost to follow-up), assessed up to 2 years ]
    Will use the rank preserving structure failure time model for the overall survival analysis.

  2. Objective response rate assessed by Response Evaluation Criteria in Solid Tumors version 1.1 [ Time Frame: Up to 2 years ]
    The exact 95% confidence interval of objective response rate will be reported based on the binomial distribution. The multivariate data analysis will be completed using the logistic regression model. The adjusted p-value and adjusted 95% confidence interval will also be reported.

  3. Prostate-specific antigen response rate [ Time Frame: Up to 2 years ]
    Prostate-specific antigen response will be defined by prostate-specific antigen decline from baseline > 50%, confirmed by a second value at 3-4 weeks later. Prostate-specific antigen response rate analysis will be based on a subset of patients who had prostate-specific antigen progression prior to enrollment. The multivariate data analysis will be completed using the logistic regression model.

  4. Correlation between homologous recombination deficiency status and radiographic progression free survival by BROCA-homologous recombination test [ Time Frame: Up to 2 weeks prior to start of therapy ]
    Homologous recombination deficiency positive status is defined by presence of homozygous deletion or deleterious mutations in key homologous recombination genes of deoxyribonucleic acid repair genes as analyzed by BROCA-homologous recombination test. The data analysis will be completed using Fisher's exact test. The multivariate data analysis will be completed using the generalized non-linear model.

  5. Incidence of genomic alterations by whole exome sequencing and transcriptome sequencing [ Time Frame: Up to 2 years ]
    The biomarker data analysis will be completed using Lasso-based elastic net method.

  6. incidence of adverse events [ Time Frame: Up to 2 years ]
    Will be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (CTCAE version 5.0 will be effective by April 1, 2018). Descriptive statistics, including means, standard deviations, and ranges for continuous parameters, as well as percentages and frequencies for categorical parameters, will be presented. Adverse medical events will be tabulated. NCI toxicity grade 3 and grade 4 laboratory abnormalities will be listed and tabled.


Other Outcome Measures:
  1. Baseline predictive biomarkers by plasma angiome [ Time Frame: Baseline ]
    The data analysis will be completed using Lasso-based elastic net method.

  2. On-treatment markers of acquired resistance by plasma angiome [ Time Frame: Up to 2 years ]
    The data analysis will be completed using Lasso-based elastic net method.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients must have histologically confirmed progressive, metastatic castration resistant prostate adenocarcinoma by meeting ALL the following:

    • Pathology of prostate gland or metastatic disease must confirm the diagnosis of prostate adenocarcinoma; mixed histology with other variants including but not limited to small cell or neuroendocrine differentiation must be discussed with the study principal investigator (PI)
    • Metastasis must be documented by radiographic evidence
    • Castration resistance must be documented with surgical or medical castration with serum testosterone < 50 ng/d (< 2.0 nM); if the patient is being treated with luteinizing hormone-releasing hormone (LHRH) agonists (patient who has not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to cycle 1, day 1 and must be continued throughout the study
    • Progression must be evidenced and documented by any of the following parameters

      • Two consecutively rising PSA values, above the baseline, at a minimum of 1-week intervals; the minimal value to enter the study is 1.0 ng/ml or greater; the reference value (#1) is the last PSA measured before increases are documented, with subsequent values obtained a minimum of 1 week apart; if the PSA at time point 3 (value #3A) is greater than that at point 2, then eligibility has been met; if the PSA is not greater than point 2 (value #3B), but value #4 is, the patient is eligible assuming that other criteria are met, if values 3A or #4 are 1 ng/mL or higher (Prostate Cancer Working Group 3)
      • Appearance of one or more new lesions on bone scan
      • Progressive disease by RECIST 1.1
  • Must have a tumor lesion safely accessible for biopsy per the investigator's discretion; while a soft tissue metastasis is preferred for a biopsy, a bone metastasis is allowed for biopsy as long as enough cores can be obtained; a biopsied lesion cannot be used for target lesion for response assessment
  • Must be agreeable to the mandatory research tumor biopsies (pre-treatment and on-treatment); tumor biopsies are mandatory at pre-treatment and at on-treatment; there is an optional biopsy at post-progression
  • Must have received at least two one prior line of therapy for mCRPC; a taxane chemotherapy administered for metastatic castration sensitive disease will not count, unless patient develops disease progression within 12 months from the last dose chemotherapy
  • Must have a life expectancy greater than or equal to 16 weeks
  • If patient is currently on prednisone or other corticosteroids for palliation, the dose must be less than or equal to 10 mg a day or its equivalent dose and it must have been started at least 4 weeks prior to cycle 1 day 1
  • Patients must have measurable disease by RECIST v1.1, or evaluable disease with bone metastases demonstrated by Tc99 bone scan; patients with bone metastases only are allowed (NOTE: nodes >= 1.5 cm (not >= 2 cm) in the short axis are considered measurable, per The Prostate Cancer Working Group 3 [PCWG3])
  • Toxicities of prior therapy (except alopecia) should be resolved to =< grade 1 as per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0; patients with long-standing stable grade 2 neuropathy or others (e.g., adrenal insufficiency or hypothyroidism on stable doses of replacement therapy) may be allowed after discussion with the study principal investigator (PI)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Karnofsky >= 70%)
  • Within 28 days prior to administration of study treatment: White blood count (WBC) > 3 x 10^9/L
  • Within 28 days prior to administration of study treatment: Absolute neutrophil count >= 1,500/mcL
  • Within 28 days prior to administration of study treatment: Platelets >= 100,000/mcL
  • Within 28 days prior to administration of study treatment: Hemoglobin >= 10 g/dL with no pack red blood cell transfusion in the past 28 days
  • Within 28 days prior to administration of study treatment: Creatinine clearance >= 51 mL/min, calculated using Cockcroft-Gault formula
  • Within 28 days prior to administration of study treatment: Urine protein: creatinine ratio (UPC) of =< 1
  • Within 28 days prior to administration of study treatment: Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN)
  • Within 28 days prior to administration of study treatment: Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) < 3 times institutional ULN unless liver metastases are present in which case they must be < 5 x ULN
  • Within 28 days prior to administration of study treatment: Coagulation parameters (international normalized ratio [INR] and activated partial thromboplastin time [aPTT]) within 1.25 x ULN institutional limits, except where a lupus anti-coagulant has been confirmed, or except patients on anticoagulation
  • Patients must be able to swallow oral medications and not have gastrointestinal illnesses that would preclude absorption of cediranib or olaparib
  • Adequately controlled thyroid function, with no symptoms of thyroid dysfunction; patients can be on thyroid hormone replacement medication; asymptomatic patients with elevated thyroid-stimulating hormone (TSH) with normal T4/T3 are allowed to enroll, and recommended to follow with routine thyroid function test especially if they are randomized to cediranib/olaparib arm
  • Adequately controlled blood pressure (BP) < 140 mmHg (systolic) and < 90 mmHg (diastolic) taken in the clinic setting by a medical professional within 2 weeks prior to starting study; patients with hypertension may be managed with up to a maximum of 3 antihypertensive medications; patients who are on 3 antihypertensive medications are highly recommended to be followed by a cardiologist or blood pressure specialist for management of BP while on protocol
  • Patients must be willing and able to check and record daily blood pressure readings when randomized to cediranib containing arm
  • Patients must have documented left ventricular ejection fraction (LVEF) by echocardiogram greater than institution's lower limit of normal (or 55% if threshold for normal not otherwise specified by institutional guidelines) obtained within 3 months prior to registration if they have any of the following risk factors for cardiac toxicities:

    • A New York Heart Association (NYHA) classification of II controlled with treatment
    • Prior central thoracic radiation therapy (RT), including RT to the heart
    • History of myocardial infarction within 12 months prior to registration
    • Prior treatment with anthracyclines
    • Prior treatment with trastuzumab
    • Prior history of other significant impaired cardiac function
  • Male participants and their female partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination (see below for acceptable methods), and not to donate sperm, throughout the period of taking study treatment and for 3 months after last dose of study drug(s) to prevent pregnancy in a partner; acceptable methods of contraception to be used in this study include:

    • Condom with spermicide and one of the following:

      • Oral contraceptive or hormonal therapy (e.g. hormone implants)
      • Placement of an intra-uterine device
    • Acceptable non-hormonal birth control methods include:

      • Total sexual abstinence; abstinence must be for the total duration of the study and the drug washout period
      • Vasectomized sexual partner plus male condom; with participant assurance that partner received post-vasectomy confirmation of azoospermia
      • Tubal occlusion plus male condom with spermicide
      • Intrauterine device (IUD) plus male condom+spermicide; provided coils are copper-banded
    • Acceptable hormonal methods:

      • Etonogestrel implants (eg, Implanon, Norplan) + male condom with spermicide
      • Normal and low dose combined oral pills + male condom with spermicide
      • Norelgestromin/ethinyl estradiol (EE) transdermal system + male condom with spermicide
      • Intravaginal device + male condom with spermicide (eg, EE and etonogestrel)
      • Cerazette (desogestrel) + male condom with spermicide; cerazette is currently the only highly efficacious progesterone based pill
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients who have had chemotherapy, hormonal therapy (except LHRH agonist or antagonist), immunotherapy, radioisotope therapy, or RT within 21 days prior to start of the study agents
  • Initiating bisphosphonate, or RANKL antibody therapy or adjusting the dose/regimen within 30 days prior to cycle 1 day 1 is prohibited; patients on a stable bisphosphonate regimen are eligible and may continue
  • Patients who have received any other investigational agents within the past 28 days prior to cycle 1 day 1
  • Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans are excluded from this clinical trial; while screening brain MRI is not required, it should be performed if clinically indicated at the discretion of the treating investigator; should patient found to have brain metastasis, treatment of brain metastasis must precede the participation in this study
  • For patients with known and treated brain metastases is allowed in this study if they fulfill ALL of the following criteria:

    • The lesions have remained radiologically stable for at least six weeks after completion of brain irradiation or stereotactic brain radiosurgery, and must remain stable at the time of study entry
    • There is no mass effect present radiologically and no steroids requirement for symptom control for more than 4 weeks
  • Patients who have received a prior inhibitor of vascular endothelial growth factor (VEGF) signaling inhibitor, or a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor administered
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib or olaparib
  • Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir), moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil), strong CYP3A inducers (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil); a minimum washout period of 2 weeks prior to cycle 1 day 1 is required for strong inhibitors, and at least one week for moderate inhibitors; a minimum washout period of 4 weeks prior to cycle 1 day 1 is required for CYP3A inducers; a minimum washout period of 5 weeks prior to cycle 1 day 1 is required for enzalutamide or phenobarbital; dihydropyridine calcium-channel blockers are permitted for management of hypertension
  • Current use of natural herbal products or other "folk remedies"; if using previously, patients must stop using natural herbal products while participating in this study; multivitamin, calcium (Ca)/vitamin D (Vit D) and other vitamin complex supplements are allowed
  • Patients with concomitant or prior invasive malignancies within the past 5 years; subjects with limited stage basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the breast, or non-muscle invasive bladder cancer, are eligible as long as they received curative intent therapy
  • \Uncontrolled intercurrent illness including, but not limited to, uncontrolled seizures ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Resting ECG with corrected QT (QTc) > 470 msec on two or more time points within a 24 hour period, noted within 14 days of treatment, or family history of long QT syndrome
  • History of myocardial infarction within 6 months of the randomization
  • History of stroke or transient ischemic attack within 6 months of the randomization
  • NYHA classification of III or IV
  • Current cardiac arrhythmic condition requiring concurrent use of anti-arrhythmic drug; rate controlled atrial fibrillation is allows
  • History of hypertensive crisis or hypertensive encephalopathy within 3 years of the randomization
  • Clinically significant peripheral vascular disease or known abdominal aortic aneurysm ( > 5 cm in diameter) or history of aortic dissection; patients with known history of abdominal aortic aneurysm (AAA) with >= 4 cm in diameter, a repeat ultrasound (US) within the last 6 months prior to randomization will be required to document that it is =< 5 cm, and patient must be asymptomatic from the aneurysm, and the blood pressure must be well controlled as required in this protocol
  • A major surgical procedure, open biopsy, or significant traumatic injury within 3 months prior to cycle 1 day 1 (percutaneous/endobronchial/endoscopic biopsies are allowed)
  • History of bowel obstruction within 1 month prior to starting study drugs
  • History of hemoptysis within the last 1 month prior to randomization
  • Presence of cavitation of central pulmonary lesion, or radiographic evidence of pneumonitis or other extensive bilateral lung disease such as interstitial lung disease
  • Any history of gastrointestinal (GI) perforation, history of intra-abdominal abscess within 3 months prior to starting treatment, or history of abdominal fistula unless the fistula history meets all the following: (a) the fistula was surgically repaired, (b) there has been no evidence of fistula for at least 6 months prior to starting treatment, (c) patient is deemed to be at low risk of recurrent fistula, and (d) the case must be discussed with the study PI
  • Current dependency on intravenous (IV) hydration or total parenteral nutrition (TPN)
  • Known coagulopathy or bleeding diathesis; those on therapeutic anticoagulation or anti-platelet agent are permitted only after discussing with the study PI
  • Patients with history of intra-abdominal bleeding or retroperitoneal bleeding within the last 3 years are excluded
  • Patients with myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML), or features suggestive of MDS/AML
  • Patients with known active human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; patients with a history of hepatitis B or hepatitis C, who are deemed cured and no longer require treatment may be allowed to enroll after con

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): NCT02893917


Locations
United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Site Public Contact    858-822-5354    cancercto@ucsd.edu   
Principal Investigator: Rana R. McKay         
University of California Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Site Public Contact    916-734-3089      
Principal Investigator: Mamta Parikh         
University of California San Diego Recruiting
San Diego, California, United States, 92103
Contact: Site Public Contact    858-822-5354    cancercto@ucsd.edu   
Principal Investigator: Rana R. McKay         
United States, Connecticut
Smilow Cancer Center/Yale-New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Site Public Contact    203-785-5702    canceranswers@yale.edu   
Principal Investigator: Joseph W. Kim         
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Site Public Contact    203-785-5702    canceranswers@yale.edu   
Principal Investigator: Joseph W. Kim         
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Site Public Contact    800-456-7121    canceranswers@moffitt.org   
Principal Investigator: Jingsong Zhang         
United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Site Public Contact    877-726-5130      
Principal Investigator: Mary-Ellen Taplin         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Mary-Ellen Taplin         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Site Public Contact    617-667-9925      
Principal Investigator: Mary-Ellen Taplin         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Site Public Contact    877-442-3324      
Principal Investigator: Mary-Ellen Taplin         
United States, Michigan
Wayne State University/Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Site Public Contact    313-576-9790    ctoadmin@karmanos.org   
Principal Investigator: Ulka N. Vaishampayan         
Weisberg Cancer Treatment Center Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Site Public Contact    313-576-9790    ctoadmin@karmanos.org   
Principal Investigator: Ulka N. Vaishampayan         
United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Site Public Contact    800-293-5066    Jamesline@osumc.edu   
Principal Investigator: J. P. Monk         
United States, Pennsylvania
University of Pittsburgh Cancer Institute (UPCI) Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Site Public Contact    412-647-8073      
Principal Investigator: Leonard J. Appleman         
United States, Tennessee
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Site Public Contact    800-811-8480      
Principal Investigator: David D. Chism         
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Site Public Contact       mwellons@vcu.edu   
Principal Investigator: Asit K. Paul         
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Joseph Kim Yale University Cancer Center LAO

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02893917     History of Changes
Other Study ID Numbers: NCI-2016-01346
NCI-2016-01346 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2000020461
9984 ( Other Identifier: Yale University Cancer Center LAO )
9984 ( Other Identifier: CTEP )
UM1CA186689 ( U.S. NIH Grant/Contract )
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Carcinoma
Prostatic Neoplasms
Adenocarcinoma
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Olaparib
Cediranib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors