Tartar Republic, Russian Federation
4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Phase
3Span
174 weeksSponsor
4D Molecular TherapeuticsPortland, Oregon
Recruiting
HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry
Longitudinal, multi-center, and non-interventional registry. Patients will be identified as eligible for pulmonary artery pressure sensor implant by a heart failure cardiologist from the heart failure clinic. They will consent for device implant and procedure (right heart catheterization) per standard of care. Patients may also consent to the registry participation, which is optional. They will be informed that the registry intends to gather data and that they may be approached in the future for additional research based on their data and clinical situation. Additionally, patients who underwent pulmonary artery pressure sensor implantation from January 1, 2019, will be identified and consent will be obtained for registry participation, which is optional.
Phase
N/ASpan
428 weeksSponsor
University of Kansas Medical CenterPortland, Oregon
Recruiting
Impella RP Flex with Smart Assist
Phase
N/ASpan
105 weeksSponsor
Abiomed Inc.Portland, Oregon
Recruiting
Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer
PRIMARY OBJECTIVE: I. To determine investigator assessed progression-free survival using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 (non-inferiority) for one versus (vs.) two years of maintenance olaparib. SECONDARY OBJECTIVES: I. To evaluate overall survival (OS360) in the modified intent to treat (ITT) population, with time at risk for progression/death starting 360 days after randomization. II. To evaluate progression-free survival (PFS), PFS2 and overall survival (OS) in the ITT population. III. To evaluate PFS, PFS2, and OS in the as-treated population. IV. To evaluate toxicity, including rates of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), and other secondary malignancies, in the safety population. EXPLORATORY OBJECTIVE: I. To evaluate the moderating effect of physician-choice bevacizumab (as stratified) on randomized treatment effect estimates. TRANSLATIONAL OBJECTIVES: I. To assess BRCA reversion mutations in circulating tumor deoxyribonucleic acid (ctDNA) as a predictor of poor response in the BRCA mutated (BRCAm) population. II. To correlate a combined assay assessing quantitative BRCA1 and RAD51C promoter methylation and pathogenic variants in core homologous recombination repair (HRR) genes with clinical homologous recombination deficiency (HRD) testing and outcomes in the BRCA wildtype (BRCAwt) population. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (REFERENCE): Patients receive olaparib orally (PO) twice daily (BID) on days 1-21 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may also receive bevacizumab IV on day 1 of each cycle. Cycles of bevacizumab repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study. ARM II (EXPERIMENTAL): Patients receive olaparib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients may also receive bevacizumab IV on day 1 of each cycle. Cycles of bevacizumab repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and CT and/or MRI throughout the study. After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years.
Phase
3Span
512 weeksSponsor
NRG OncologyPortland, Oregon
Recruiting
A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of ANX007 in Participants With Geographic Atrophy (GA)
Phase
3Span
170 weeksSponsor
Annexon, Inc.Portland, Oregon
Recruiting
Tailoring Therapy in Post-surgical Patients With Low-risk Endometrial Cancer
PRIMARY OBJECTIVE: I. Estimate the rate of pelvic recurrence at 3 years in patients who are treated with a de-escalated adjuvant treatment directed by tumour molecular status. SECONDARY OBJECTIVES: I. Estimate the rate of isolated vaginal recurrence, para-aortic recurrence and distant metastasis at 3 years. II. Estimate the recurrence-free, endometrial cancer-specific and overall survival. III. Describe the impact of molecular classification on patient decisional conflict and fear of recurrence. TERTIARY OBJECTIVES: I. Evaluate health economic impact of molecular classification-tailored adjuvant therapy on the cost of treating endometrial cancer. II. Evaluate quality of life. III. Determine if variability in adjuvant treatment given to patients with endometrial cancer is decreased by molecular classification-tailored adjuvant therapy as compared to recent clinical practice data. IV. To assess if additional molecular parameters can further refine prognosis within POLE-mutated and p53wt/no specific molecular profile (NSMP) endometrial cancer (EC). OUTLINE: Patients are assigned to 1 of 2 sub-studies. SUB-STUDY A: Patients are assigned to 1 of 2 cohorts. COHORT A1: Patients with POLE-mutated early-stage EC undergo observation on study. COHORT A2: Patients with higher-risk POLE-mutated EC undergo observation or external beam radiation therapy (EBRT) and/or vaginal brachytherapy over 3-5 fractions. SUB-STUDY B: Patients with p53 wildtype/NSMP ER+ EC undergo observation or vaginal brachytherapy over 3-5 fractions. All patients undergo chest x-ray and computed tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT scans during screening and as clinically indicated throughout the trial. After completion of study treatment, patients are followed up at 3 and 6 months, then every 6 months for 3 years, and then every year.
Phase
2Span
103 weeksSponsor
NRG OncologyPortland, Oregon
Recruiting
Neoadjuvant INBRX-106 (Hexavalent OX40 Agonist) in Combination With Pembrolizumab as a Chemotherapy-sparing Regimen for Stage II TNBC (Triple Negative Breast Cancer) Patients
A Simon 2-stage design is implemented to minimize exposure if the treatment regimen is futile. If feasibility is established with responses exceeding futility parameters, study will expand to stage 2. Additional arms may be introduced in a protocol amendment. Below shows the sample size required using Simon's 2-stage design, 80% power and 5% one-sided significance level: - Null hypothesis: <5% pCR - Alternative hypothesis: >35% pCR - Stage I n (r*): 6 (0) - Stage I + II total n (r): 12 (2) - Criteria: Minimax - Minimum responses to proceed to stage II: 1 Note: r* and r represents the threshold for declaring futility, i.e. greater than r* or r responses would be required to consider ongoing investigation. The null hypothesis of 5% is based upon the assumption that virtually no subjects would experience pCR if the therapy was not effective. The alternative hypothesis of 35% is based upon the assumption that complete responses in the absence of chemotherapy in approximately one-third of subjects would be clinically meaningful, encouraging further development of the treatment paradigm. If no responses are observed, a second feasibility run-in may be considered using a biomarker enrichment strategy (such as with the 27-gene IO score). The arm will be terminated from further development if an unacceptable proportion of patients experience rapid clinical/radiographic progression (defined as progression of disease, or clinical evidence of progression), or other toxicities that interfere with curative-intent therapy, defined as >1/6 evaluable subjects in stage I or >2/12 in stage II, evaluated for each arm. This is a Pocock-type stopping boundary that yields the probability of cross the boundary at most 23% when the rate of dose-limiting toxicity is equal to 10%.
Phase
2Span
252 weeksSponsor
Providence Health & ServicesPortland, Oregon
Recruiting
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 (pirfenidone solution for inhalation) versus placebo on top of standard of care in participants with PPF over 52 weeks. Up to 300 eligible participants will be randomized to 1 of 3 treatment arms: AP01 high dose, AP01 low dose, or placebo.
Phase
2Span
109 weeksSponsor
Avalyn Pharma Inc.Portland, Oregon
Recruiting
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM
Phase
3Span
161 weeksSponsor
CytokineticsPortland, Oregon
Recruiting
Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer
This study is being done to find out if this approach is better or worse than the usual approach for early rectal cancer. The usual approach is defined as care most people get for early rectal cancer. The usual approach for patients who are not in a study is surgery to remove the rectum or treatment with chemotherapy and radiation therapy, followed by surgery. There are several chemotherapy drugs approved by Health Canada that are commonly used with radiation therapy. For patients who get the usual approach for this cancer, about 90 out of 100 are free of cancer after 5 years. If a patient decides to take part in this study, they will either get a combination of chemotherapy drugs called FOLFOX or CAPOX for up to 12 weeks or will get chemotherapy with radiation therapy for up to 6 weeks. After finishing treatment, and even if treatment is stopped early, the study doctor will watch for side effects and determine which type of surgery would be best. After surgery, patients will be asked to come in every 4 months for 2 years, then every 6 months for an additional year. Then will be checked every year for 2 years. This means seeing the study doctor for up to 5 years after surgery. Patients may be seen more often if your study doctor thinks it is necessary.
Phase
3Span
314 weeksSponsor
Canadian Cancer Trials GroupPortland, Oregon
Recruiting