Enrolling Clinical Trials

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1 188 W. Northern Lights Blvd, Suite 800 Anchorage, AK Telephone: Fax: Enrolling Clinical Trials Allergan Study to evaluate the safety and efficacy of Botox for the treatment urinary incontinence due to OAB in pediatric patients ages Inc: Patient has not be adequately controlled by one or more anticholinergic Exc: Patient has symptoms of OAB due to any neurological reason Altor Protocol CA-ALT A phase Ib/II study of BCG in combination with ALT-803 in patients with BCG-naïve non-muscle invasive bladder cancer Inc: Intermediate to high grade bladder cancer patients who are candidates for BCG therapy Exc: prior BCG treatment, metastatic disease Altor Protocol CA-ALT QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination with ALT-803 in Patients with BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer Inc: BCG-unresponsive disease as defined as: a. Persistent high-grade disease or recurrence within 6 months of receiving at least two courses of intravesical BCG (at least five of six induction doses and at least two of three maintenance doses); or b. T1 high-grade disease at the first evaluation following induction BCG alone (at least 5 of six induction doses) Exc: Recurrence > 1 year after last BCG instillation. Astellas ONC-MA A Prospective Observational Cohort Study of Patients with Castration- Resistant Prostate Cancer (CRPC) in the United States Inc: Confirmed diagnosis of CRPC (defined by a minimum of two rising PSA levels to be measured at least 7 days apart, and serum testosterone level 1.73 nmol/l (50 ng/dl) or with new evidence of metastatic disease) by investigating physician Initiating the first active course of anti-cancer treatment for M0 CRPC or for M1 CRPC Exc: Receiving concomitant treatment for other cancer (excluding basal cell carcinoma and treatment for hormone sensitive prostate cancer) within 6 months prior to enrollment.

2 Astellas 178-MA A Phase 4, Double-Blind, Randomized, Placebo-controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men with Overactive Bladder (OAB) Symptoms While Taking the Alpha Blocker Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH) Inc: Men 40 years of age with history of OAB symptoms (urinary frequency and urgency with or without incontinence) while taking tamsulosin hydrochloride 0.4 mg daily for at least 2 months to treat LUTS due to BPH. Exc: Subject has neurogenic bladder (spinal cord injury, multiple sclerosis, Parkinson s etc.). AstraZeneca D081DC A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza ) Versus Enzalutamide or Abiraterone Acetate in Men with Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment with a New Hormonal Agent and Have Homologous Recombination Repair Gene Mutations (PROfound) Inc: Subjects must have progressed on prior NHA (e.g. abiraterone acetate and/or enzalutamide) for the treatment of mcrpc. Determination of progression is done per local investigator. Qualifying HRR mutation in tumor tissue by the Lynparza HRR Assay. Either archival or de novo biopsies are acceptable. If subjects have a mutation in one of the 15 HRR genes based on prior prostate cancer tissue specimen testing by the commercially available FoundationOne assay, they must have the mutation confirmed as a qualifying mutation. Exc: Any previous treatment with PARP inhibitor, including olaparib. Subjects who have any previous treatment with DNA-damaging cytotoxic chemotherapy. For example, subjects who have received prior mitoxantrone or platinum-based chemotherapy are excluded. Prior estramustine is allowed AstraZeneca D4191C An Open-Label, Multi-Centre, Safety Study of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies (STRONG) Module A Post-Chemotherapy Urothelial and NonUrothelial Carcinoma of the Urinary Tract Inc: Disease that has progressed during or after at least one previous platinum or nonplatinum based chemotherapy, either for metastatic disease or progressive disease less than 12 months after adjuvant or neo-adjuvant chemotherapy Exc: Any concurrent chemotherapy, investigational agent, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable. Bayer Orion A Multinational, Randomized, Double-Blind, Placebo-Controlled, Phase III Efficacy and Safety Study of ODM-201 in Men with High-Risk Non-Metastatic Castrate-Resistant Prostate Cancer Inc: Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features; Progressive disease defined as CRPC with 3 rising PSA levels during ADT Exc: History of metastatic disease or presence of detectable metastases by blinded central reading. Presence of pelvic lymph nodes < 2 cm in short axis below the aortic bifurcation is allowed.

3 Bayer A Phase III, randomized, double-blind, controlled, multicenter study of intravenous PI3K inhibitor copanlisib in combination with standard immunochemotherapy versus standard immunochemotherapy in patients with relapsed indolent non-hodgkin s lymphoma (inhl) - CHRONOS-4 Inc: Histologically confirmed diagnosis of CD20 positive inhl with histological subtype limited to: Follicular lymphoma (FL) grade 1, grade 2, or grade 3a, Small lymphocytic lymphoma (SLL) with absolute lymphocyte count< 5 x 109/L at study entry, Lymphoplasmacytic lymphoma/waldenström macroglobulinemia(lpl/wm), Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal). Patients must have relapsed (recurrence after complete response or presented progression after partial response) or progressed after at least one but at most three prior lines of therapy. Exc: Histologically confirmed diagnosis of follicular lymphoma (FL) grade 3b or transformed disease, or chronic lymphocytic leukemia. In patients with clinical suspicion of transformed disease a fresh biopsy is recommended. Rituximab resistance at any line of therapy (resistance defined as lack of response, or progression within 6 months of the last course of treatment with a rituximab containing regimen, including rituximab maintenance). Bristol-Meyers Squibb Protocol CA A phase 3 randomized, double-blind, multi-center study of adjuvant Nivolumab versus placebo in subjects with high risk invasive urothelial carcinoma Inc: Patients must be status post radical resection, be ineligible for cisplatin therapy and must have disease free status Exc: Partial cystectomy or partial nephrectomy Bristol-Meyers Squibb Protocol CA A Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab versus Standard of Care Chemotherapy in Participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer Inc: Histological or cytological evidence of metastatic or surgically unresectable transitional cell carcinoma (TCC) of the urothelium involving the renal pelvis, ureter, bladder or urethra. Minor histologic variants (< 50% overall) are acceptable (TCC must be the dominant histology). Measurable disease by CT or MRI per RECIST 1.1 criteria. Exc: ECOG PS 2. Disease that is suitable for local therapy administered with curative intent. Active brain metastases or leptomeningeal metastases Bristol-Meyers Squibb Protocol CA Phase 3b/4 Safety Trial of Nivolumab Combined with Ipilimumab in Subjects with Previously Untreated, Advanced or Metastatic RCC Inc: Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC Histologically confirmed, previously untreated (treatment-naive) RCC Exc: Prior systemic treatment in the metastatic setting with VEGF or VEGF receptor targeted Therapy. Prior treatment with an anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti CTLA 4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.

4 Daiichi Sankyo DS8201-A-U201- A Phase 2, Multicenter, Open-Label study of DS-8201a, an Anti-Her2- Antibody drug conjugate (ADC) for Her2-Postitive, Unresectable and/or Metastatic Breast Cancer subjects who are resistant or refractory to T-DM1A. Inc: has confirmed HER2 positive expression (estrogen receptor/progesterone receptor positive subjects may be enrolled if they are HER2 positive) according to American Society of Clinical Oncology College of American Pathologists (ASCO-CAP) guidelines22 evaluated at a Central Laboratory. Subject must have breast cancer which is resistant or refractory to T-DM1 with documented clinical or radiographic progression of disease during or after treatment with T-DM1. Exc: Medical history of myocardial infarction within 6 months before registration, symptomatic congestive heart failure (CHF), troponin levels consistent with myocardial infarction as defined according to American College of Cardiologists (ACC) guidelines,unstable angina, or serious cardiac arrhythmia requiring treatment. Has a corrected QT interval (QTc) prolongation to > 470 msec (females) or>450 msec (males) based on average of the screening triplicate12-lead ECG Ferring A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients with Prostate Cancer and Cardiovascular Disease Receiving Degarelix (GnRH Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist) Inc: Investigator judgment indication to initiate continued androgen deprivation therapy (ADT) with an intended treatment duration of 12 months or longer. Patients should satisfy one of the following disease categories: A. Advanced prostate cancer, B. Postradiation therapy recurrence, C. Post-radical prostatectomy biochemical failure. Exc: Previous or current hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, megestrol acetate, ketoconazole, abiraterone and enzalutamide); except neoadjuvant/adjuvant hormonal therapy for a maximum duration of 6 months. GTX G Double-Blind, Placebo-Controlled, Parallel Design, Phase 2 Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence. Inc: Predominant SUI as determined at the Screening Visit using the Medical, Epidemiological, and Social Aspects of Aging (MESA) urinary questionnaire. A minimum of 1 and no more than 15 stress incontinence episodes on any single day AND no fewer than 9 total stress incontinence episodes over 3 days as reported in the 3-day voiding diary, determined during the Screening Period. SUI symptoms of at least 6 months duration. Exc: History of urethral sling or anterior prolapse repair. Treatment with urethral bulking agents and/or other SUI procedure or surgery within the 6 months prior to the Screening Visit

5 Medivation MDV A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy Inc: Prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent. Screening PSA 2.0 ng/ml for patients who had radical prostatectomy as primary treatment for prostate cancer or 5.0 ng/ml and greater than or equal to the nadir + 2 ng/ml for patients who had radiotherapy as primary treatment for prostate cancer. Exc: Prior or present evidence of distant metastatic disease Myovant Sciences HERO (MVT )- A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men with Advanced Prostate Cancer Inc: Is a candidate for, in the opinion of the investigator, at least 1 year of continuous androgen deprivation therapy for the management of androgen-sensitive advanced prostate cancer with one of the following clinical disease state presentations: a. Evidence of biochemical (PSA) or clinical relapse following local primary intervention with curative intent; or b. Newly diagnosed androgen-sensitive metastatic disease; or c. Advanced localized disease not suitable for local primary surgical intervention with curative intent. Exc: Previously received GnRH analog or other form of androgen deprivation therapy (estrogen or antiandrogen) for > 12 months total duration. If androgen deprivation therapy was received for 12 months total duration, then that therapy must have been completed at least 12 months prior to baseline; Novartis Signature Trial-Phase II study to link targeted therapy to patients with pathway activated tumors. Treatment is determined by tumor mutation and open protocols. Inc: Must submit tumor sample to foundation one for determination of molecular aberration as initial step. Inclusion and Exclusion based on tumor mutations. Spectrum SPI-QAP-306- A Randomized, Multicenter, Two-Arm, Single-Dose, Double-Blind, Placebo- CONtrolled Phase 3 Study of Intravesical Qapzola (Apaziquone) as a Chemotherapy Adjuvant to TransUrEthral Resection of Bladder Tumors in Patients with Low- to Intermediate-Risk Non-Muscle Invasive Bladder Cancer (CONQUER) Inc: Patient must have a clinical diagnosis of low- to intermediate-risk non-muscle invasive bladder cancer according to the 2016 American Urological Association (AUA) Guidelines, except for strongly-suspected PUNLMP Exc: Patient has a history of allergy to red color food dye or any other component of Qapzola, placebo, or their diluents. Patient has had a surgical procedure 4 weeks prior to TURBT or will have other surgical procedures performed at the time of TURBT or within 4 weeks after TURBT.

6 United Therapeutics- A Two-Part, Open-Label, Randomized, Phase II/III Study of Dinutuximab and Irinotecan versus Irinotecan for Second Line Treatment of Subjects with Relapsed or Refractory Small Cell Lung Cancer Inc: Documented (radiographic evidence of) relapse or disease progression during or after firstline platinum-based therapy (subjects refractory to initial platinum-based therapy are eligible). Have no curative therapy available. Exc: Candidate for re-treatment with original platinum-based regimen as second-line therapy. Prior treatment with irinotecan, topotecan or dinutuximab. UroGen Pharma TC-UT-03- A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of MitoGel on Ablation of Upper Urinary Tract Urothelial Carcinoma Inc: Naive or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system. Patient has at least one (1) measurable and biopsy-confirmed papillary LG tumor, evaluated visually, 15 mm. The largest lesion should not exceed 15mm. Exc: Patient received BCG treatment for UC during the 6 months prior to Visit 1. Carcinoma in situ (CIS) in the past in the urinary tract.

7 Current Clinical Trials with Closed Enrollment Allergan Protocol GMA-OAB-113-A study of Overactive Bladder Patients with Urinary Incontinence to evaluate the relative efficacy and safety of Botox 100 U compared to Placebo in achieving 100% reduction (complete continence) in urinary incontinence, whose symptoms have not been adequately managed using anticholinergic Aragon Protocol ARN Study of ARN-509 vs. Placebo in men with non-metastatic Castrateresistant Prostate Cancer ARNO Therapeutics- A phase 1-2 Study of Onapristone in patients with advanced castrate resistant prostate cancer Astellas 9785-CL-0335-A Phase 3, Randomized, Double-Blind, Placebo-controlled efficacy and safety study of enzalutamide plus ADT vs placebo plus ADT in patients with metastatic, hormone sensitive prostate cancer Astellas Protocol 9785-CL-0403-Study of MDV3100 to evaluate risk of Seizures among subjects with Auxilium Protocol AUX-CC-810-Long-term Study of Xiaflex in Patients with Peyronie s Disease Bayer Xofigo/Abi A phase III randomized, double-blind, placebo-controlled trial of radium-223 dichloride in combination with abiraterone acetate and prednisone in the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve subjects with bone predominant metastatic castrationresistant prostate cancer (CRPC) Bayer REASSURE This observational prospective single arm cohort study is designed to assess the incidence of second primary malignancies among patients with metastatic Castration Resistant Prostate Cancer (mcrpc) receiving Radium-223 in routine clinical practice. BN Immunotherapeutic Protocol BNIT-PRV-301-Study of Prostvac-V/F with or without GM-CSF versus Placebo in Treating Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer Cold Genesys BOND II- An Open-label, single arm, phase II, study of the safety and efficacy of CG0070 oncolytic vector in patients with non-muscle invasive bladder carcinoma who have failed BCG therapy and refused cystectomy. Novartis LEE011A2404- COMPLEEMENT-1: An open-label, multicenter, Phase IIIb study to assess the safety and efficacy of ribociclib (LEE011) in combination with letrozole for the treatment of men and pre/postmenopausal women with hormone receptor-positive (HR+) HER2-negative (HER2-) advanced breast cancer (abc) with no prior hormonal therapy for advanced disease Spectrum SPI-EOQ A Multicenter, Multi-Arm, Randomized, Multi-Dose, Placebo- Controlled, Double-Blind, Phase 3 Study of Intravesical Apaziquone (EOquin ) as a Surgical Adjuvant in the Immediate Postoperative Period in Patients Undergoing Transurethral Resection for Non-Muscle Invasive Bladder Cancer