Abbotsford

Researchers are evaluating two standard doses of the anti-cancer drug bevacizumab, combined with chemotherapy, in women with platinum-resistant ovarian cancer. This phase 2 pragmatic trial aims to compare a lower dose (7.5 mg/kg) versus a higher dose (15 mg/kg) of bevacizumab to see if the lower dose is not less effective, while potentially causing fewer side effects. Both doses are standard in treating ovarian cancer, but only the higher dose is typically used for platinum-resistant cases. The study hopes to determine if the lower dose could change clinical practice by offering similar cancer control with better safety and cost benefits. Participants are randomly assigned to receive either 7.5 mg/kg or 15 mg/kg of bevacizumab every three weeks alongside chemotherapy. The length of treatment is decided by the treating doctors following standard care practices. Researchers will monitor how long the cancer is controlled using CT scans, track side effects, and assess quality of life between the two groups to compare their outcomes. Women in the study will undergo regular assessments including imaging scans to measure disease progression and side effect monitoring. The primary outcome is progression-free survival, measured from the time of randomization until the cancer worsens or the participant dies, assessed for up to four years. The study also includes quality of life evaluations and safety monitoring during treatment and follow-up. Total participation time depends on individual treatment duration and follow-up assessments.

This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

Researchers are evaluating the effectiveness of Saruparib (AZD5305) compared to placebo when added to a standard radiation therapy (RT) and androgen deprivation therapy (ADT) regimen in men with high-risk and very high-risk localized or locally advanced prostate cancer who have a BRCA gene mutation. This phase III study aims to assess whether Saruparib can improve metastasis-free survival in this population. About 700 adult male participants will be randomly assigned to receive either Saruparib or placebo along with ADT. There are two groups: Cohort A includes 400 participants with newly diagnosed high-risk or very high-risk prostate cancer treated with primary RT or with high-risk biochemical recurrence after radical prostatectomy receiving salvage RT. Cohort B includes 300 participants with very high-risk locally advanced prostate cancer receiving primary RT combined with ADT and abiraterone. Saruparib and placebo will be given orally, and standard ADT and abiraterone with prednisone/prednisolone will be administered as per the regimen. Participants will be followed for up to about 93 months to monitor metastasis-free survival and overall safety. Assessments include imaging scans like CT, MRI, bone scans, and PSMA-PET to confirm disease status. The study also monitors organ function, performance status, and treatment adherence. An independent committee will review safety and efficacy data throughout the trial to ensure participant well-being and study integrity.

This research investigates the effectiveness and safety of combining capivasertib with CDK4/6 inhibitors and fulvestrant in adults with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer that is locally advanced, inoperable, or metastatic. It includes a Phase Ib dose-finding portion to establish safe dosages for the triple combination, followed by a Phase III study comparing this combination to CDK4/6 inhibitors plus fulvestrant alone. The study focuses on patients who have not received prior endocrine therapy for advanced disease and aims to assess added benefit in a high-risk population. During Phase Ib, participants receive capivasertib orally twice daily for 4 days followed by 3 days off each week, combined with fulvestrant injections and one of the CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) at varying doses to find the recommended dose for Phase III. In Phase III, participants are randomized to receive capivasertib plus fulvestrant and a CDK4/6 inhibitor at the established dose or fulvestrant plus a CDK4/6 inhibitor alone, with dosing schedules maintained over 28-day cycles. Participants undergo regular monitoring including scans for tumor assessment, blood tests, and safety evaluations over extended periods—up to 47 months for progression-free survival assessment. Researchers track adverse events, serious side effects, and treatment tolerability throughout. Mandatory tumor and blood samples are collected for biomarker analysis. The study evaluates key outcomes such as dose-limiting toxicities, treatment-related adverse events, and progression-free survival, supporting long-term safety and effectiveness evaluation.

Researchers are evaluating TORL-1-23 in a Phase 2 study for women with advanced platinum-resistant epithelial ovarian cancer, including primary peritoneal and fallopian tube cancers expressing Claudin 6. This study aims to assess the safety and effectiveness of TORL-1-23 given as a single treatment in those whose disease has progressed despite prior platinum-based therapies. Eligible participants must have confirmed high-grade ovarian or related cancers and tumors positive for CLDN6 expression. The treatment involves intravenous infusions of TORL-1-23 at doses of 2.4 mg/kg, 3.0 mg/kg, or 3.4 mg/kg on Day 1 of every 3-week cycle. Additionally, participants receive a 6.0 mg subcutaneous injection of Pegfilgrastim on Day 4 of each cycle to support white blood cell counts. Treatment continues until disease progression or other criteria are met, and the study's total duration is about 40 months. Participants will be closely monitored from the first dose through the study duration with assessments at predefined intervals to measure disease response and safety. Evaluations include imaging scans to measure tumor size, laboratory tests for organ function, heart monitoring with ECG, and regular clinical exams. Researchers will track the therapy's effects on tumor progression and side effects to understand the overall benefit and safety of TORL-1-23 in this patient group.

Researchers are evaluating the effects of dalcetrapib, a cholesterol ester transfer protein inhibitor, on cardiovascular risk in people who have recently been hospitalized for acute coronary syndrome (ACS) and have a specific genetic profile (AA genotype). This phase 3, placebo-controlled, randomized, double-blind study focuses on adults aged 45 years and older. Participants must be clinically stable and managed according to guidelines for low-density lipoprotein cholesterol (LDL-C). The study aims to measure the time to the first occurrence of any fatal or non-fatal myocardial infarction over an average follow-up of 30 months. Participants will be randomly assigned to receive either dalcetrapib 300 mg tablets or matching placebo tablets. The study includes a genetic screening phase to confirm the presence of the AA genotype using a specific genotype assay test. Screening and enrollment may start during hospitalization or after discharge, with randomization required within 12 weeks of the ACS event. Follow-up visits will be conducted virtually when possible every 3 months or as clinic visits until the study ends. If a participant stops the study medication early, assessments for study endpoints will continue every 3 months. Throughout the study, participants will undergo medical history reviews, genetic testing, and regular assessments to monitor cardiovascular events. Researchers will collect data on myocardial infarction occurrences as the primary outcome. Safety and adherence will be monitored through scheduled visits, and the study will continue until about 200 participants have experienced a primary event or until a planned interim analysis determines stopping. The total participation duration varies based on event occurrence but involves ongoing follow-up every 3 months after randomization.

This research aims to improve the use of Prison Needle Exchange Programs (PNEPs) in Canadian federal prisons, focusing on people who inject drugs while incarcerated. The study involves nine federal prisons, including five women's prisons where more individuals report injection drug use. The goal is to increase program adoption and sustainability by identifying what helps and hinders participation and implementing strategies based on evidence. The study uses a step-wedge design over 24 months, with nine prisons divided into three groups that receive the intervention at staggered intervals every six months. The intervention involves the Network for the Improvement of Addiction Treatment (NIATx) model, which uses expert coaching and quality improvement tools aimed specifically at behavioral healthcare settings to enhance access and retention. After the intervention period, there is an additional 12-month phase to assess how well the program is sustained. Participants include all people incarcerated at the study sites during the intervention period. Researchers will observe changes in PNEP uptake throughout the study and monitor the effectiveness of the NIATx strategy in improving program engagement. The study also assesses sustainability of the needle exchange programs after the intervention ends, with no exclusions at the participant level since the intervention is applied site-wide.

Researchers are investigating whether adding a treatment called LND101 for Fecal Microbiota Transplant (FMT) to the usual immunotherapy, called Immune Checkpoint Blockade (ICB), can better prevent the growth or spread of advanced melanoma. The study compares this combined approach with the standard immunotherapy alone. The research focuses on advanced melanoma patients and aims to assess if changing gut bacteria with FMT affects cancer progression. Participants will receive either the usual ICB treatment or ICB combined with LND101, which involves taking about 40 capsules of processed fecal material a week before starting immunotherapy. The study includes a phase where the choice of ICB treatment is made before patients join and remains fixed. Treatments are given as approved and funded in Canada, focusing on advanced, unresectable, or metastatic melanoma. Throughout the study, participants will be monitored for progression-free survival over four years. Researchers will collect blood and stool samples and tumor tissue when available to study markers related to treatment. Patients must be able to take capsules and attend follow-up visits to track treatment effects and any side effects. The total assessment period includes treatment and long-term follow-up to evaluate outcomes and safety.

Researchers are evaluating the effects of baxdrostat combined with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.