Schiedam

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

Researchers are evaluating the safety and effects of the study medicine PF-07248144 combined with fulvestrant for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This study focuses on participants whose breast cancer has worsened after prior treatment with CDK46 inhibitor-based therapy. The trial compares PF-07248144 plus fulvestrant to the current standard treatment involving everolimus and endocrine therapy. Participants will be randomly assigned to one of two groups. One group will take PF-07248144 tablets daily at home in 28-day cycles along with fulvestrant injections administered at the clinic. The other group will receive everolimus tablets daily plus either exemestane tablets or fulvestrant injections, based on the study doctors choice. Treatments will continue according to the schedule for each participant. During the study, participants will undergo regular evaluations including scans to measure tumor response, lab tests, electrocardiograms, and monitoring of side effects. Researchers will track progression-free survival up to about two years, as well as overall survival and response duration up to about five years. Safety and drug levels will also be monitored throughout and after treatment. The total duration of participation may span several years depending on individual outcomes.

Researchers are evaluating whether combining the investigational drug PF-06821497 with enzalutamide works better than enzalutamide alone in men with metastatic castration-resistant prostate cancer mCRPC who have not yet received certain advanced anti-cancer treatments. This global, multicenter, randomized Phase 3 study focuses on participants who have not been treated with androgen receptor signaling inhibitors like enzalutamide or abiraterone before, except for androgen deprivation therapy or first-generation anti-androgen agents. The study is sponsored by Pfizer and aims to assess treatment effects in this patient population. Participants will be randomly assigned to one of two groups one group will receive PF-06821497 875 mg twice daily combined with enzalutamide 160 mg once daily, while the other will receive a placebo twice daily plus enzalutamide 160 mg once daily. The study includes several phases screening, randomization, treatment, safety follow-up, and long-term follow-up. Treatment continues over a period of up to approximately three years for primary outcomes, with ongoing assessments for up to five years for some secondary outcomes. During the study, participants will undergo various assessments including scans to monitor disease progression, blood tests to measure prostate-specific antigen levels and circulating tumor DNA, patient-reported pain and quality of life questionnaires, and evaluations of adverse events. The primary outcome is radiographic progression-free survival measured from randomization up to about three years. Safety and long-term effects will be monitored through follow-up visits lasting up to five years. Participants will be followed closely throughout the study duration to track treatment impact and side effects.

Researchers are evaluating the combination of JSB462 luxdegalutamide with abiraterone compared to an androgen receptor pathway inhibitor ARPI, which includes abiraterone or enzalutamide, in adult males with metastatic hormone-sensitive prostate cancer mHSPC. This Phase II study aims to assess the effectiveness and safety of two doses of JSB462 100 mg and 300 mg daily combined with abiraterone and to select the recommended dose for future Phase III trials. The study will analyze overall treatment response, safety, tolerability, and pharmacokinetics. Participants will undergo a screening period of 28 days before starting treatment. During treatment, they will receive daily oral doses of JSB462 at either 100 mg or 300 mg combined with abiraterone 1000 mg, or they will receive abiraterone 1000 mg or enzalutamide 160 mg alone. Treatment continues until disease progression, unacceptable side effects, death, or decision by the participant or investigator. After treatment ends, there is a 30-day safety follow-up visit, followed by a long-term follow-up period to collect ongoing safety, efficacy, and survival information until the study concludes. Throughout the study, participants will have regular assessments including prostate-specific antigen PSA levels, imaging scans, adverse event monitoring, dose adjustments, and pharmacokinetic sampling. Patient-reported outcomes and various survival and response rates will be evaluated up to approximately 83 months. Safety follow-up visits occur about 30 days after treatment stops, and long-term monitoring continues until the studys end, ensuring comprehensive data collection on treatment effects and participant well-being.

Researchers are investigating whether taking breaks from the standard combination therapy of daratumumab, lenalidomide, and dexamethasone Dara-Rd for newly diagnosed multiple myeloma patients affects survival and quality of life. This study aims to compare continuous treatment versus planned treatment-free intervals to see if stopping therapy temporarily may reduce side effects, allow recovery from toxicity, and improve overall well-being while controlling the disease. Participants who have completed 12 cycles of Dara-Rd with at least a partial response and no signs of disease progression will be randomly assigned to one of two groups. One group will continue Dara-Rd therapy without interruption until disease progression, while the other group will stop treatment temporarily and restart it at biochemical progression, continuing until disease progression. The trial is open-label and will follow patients for several years to assess outcomes. Throughout the study, researchers will monitor participants event-free survival and progression-free survival for up to about 57 and 69 months, respectively. Additional assessments include side effect burden, patient-reported quality of life, treatment costs, treatment-free interval length, response times, and survival after second-line therapy. Regular evaluations will help determine how treatment interruption affects toxicity, dose intensity, and overall treatment outcomes over the long term.

Researchers are evaluating whether survodutide can help adults with liver diseases called non-alcoholic steatohepatitis NASH or metabolic-associated steatohepatitis MASH who have cirrhosis and a body mass index BMI of 27 kgm2 or higher 25 kgm2 for Asian participants. The study compares survodutide to a placebo to see if it improves liver function and related health outcomes over time. This is a Phase III trial with participants randomly assigned to groups, and it is double-blind, meaning neither participants nor doctors know who gets the medicine or placebo. Participants receive weekly injections of survodutide or placebo under the skin and get regular counseling on diet and exercise. The study lasts up to four and a half years, with visits either in person or via video call every 2, 4, or 6 weeks for about 17 months, then every 3 months thereafter until the study ends. The study collects health data including body weight, liver imaging results, and symptom questionnaires to assess the treatment effects. During the study, doctors monitor participants health and record any side effects. Liver health is checked using imaging methods at certain visits, and participants fill out questionnaires about their symptoms. The primary outcome measures include time to serious liver-related events and overall survival. Secondary outcomes look at changes in liver fibrosis, body weight, blood sugar control, liver stiffness, and other blood markers. The study aims to provide detailed long-term information on survodutides impact on liver disease and safety.

Researchers are evaluating survodutide, a medicine given by weekly injection, in adults aged 18 and older who have obesity and a liver disease called non-alcoholic steatohepatitis NASH or metabolic associated steatohepatitis MASH with moderate or advanced liver fibrosis. The study aims to see if survodutide can improve liver function and slow disease progression. This Phase III trial compares survodutide to a placebo, with participants randomly assigned to one of the two groups, and neither participants nor doctors know who receives which treatment. Participants inject survodutide or placebo under their skin once a week, with doses gradually increasing to a target level. All participants also receive counseling to encourage diet changes and regular exercise. The study has two parts the first focuses on the effect of survodutide on liver fibrosis and MASH over 52 weeks, and the second assesses long-term safety and effectiveness up to 7 years. Participants are involved for up to 7 years, with visits to the study site or remote video calls starting every 2 weeks, then every 4 and 6 weeks, and eventually alternating every 3 months. During visits, doctors monitor health, weight, and digestive effects, perform liver imaging, and collect liver tissue samples at select times. Participants complete questionnaires about symptoms and quality of life. Researchers measure changes in liver disease markers, body weight, blood tests, and monitor safety and serious outcomes like progression to cirrhosis or liver-related events.

Researchers are investigating the effectiveness of adding liothyronine LT3 to levothyroxine LT4 treatment in patients with autoimmune hypothyroidism who continue to experience severe tiredness despite having normalized thyroid hormone levels on LT4 alone. This study addresses the problem that LT4 monotherapy may not fully replicate the natural balance of thyroid hormones, as healthy individuals produce some T3 directly. The trial also explores whether certain genetic factors influence response to combination therapy. The study begins with a run-in period where all participants switch to a standardized generic LT4 to stabilize thyroid hormone levels. After confirming normal TSH levels and persistent tiredness, participants enter a one-year randomized, double-blind trial comparing LT4LT3 combination therapy to LT4 with placebo. The LT4LT3 group takes LT4 once daily and LT3 twice daily at a set ratio. Visits occur at baseline and multiple times over the year to adjust doses and monitor health. Participants undergo physical exams, ECGs, blood tests, and complete questionnaires about tiredness, quality of life, and medical resource use throughout the study. Additional measures include bone markers, scans, cardiovascular and metabolic assessments, and neurocognitive tests in subgroups. The main outcome is the change in tiredness scores over 52 weeks, with safety and genetic factors also evaluated. The total study duration includes the run-in and treatment phases, lasting several months to over a year.

Researchers are investigating whether chemotherapy can be safely skipped for patients with certain favorable features of low stage triple-negative breast cancer after surgery and radiation. The study aims to see if avoiding chemotherapy improves patients quality of life. Participants decide with their doctors whether to have chemotherapy or not as part of their treatment. Participants receive surgery and radiotherapy based on local or national guidelines. One group will have chemotherapy omitted, while another group will receive chemotherapy in addition to surgery and radiotherapy. The study compares these two approaches to understand treatment outcomes. Participants will be monitored for up to 96 months to track disease recurrence and survival. Quality of life, fear of recurrence, health worries, and cost effectiveness will be assessed up to 2 years after inclusion. Various questionnaires and clinical evaluations will be used to measure these outcomes and ensure participant safety throughout the study.

Researchers are evaluating the Photo-Acoustic Imager 3 PAM3 to detect both benign and malignant breast lesions in women visiting an outpatient clinic. The study also assesses the devices accuracy in locating and sizing breast lesions compared to standard imaging, while considering breast density and BI-RADS score. Additional goals include examining the devices usability, patient satisfaction, safety, and developing a dedicated PAM3 terminology. All participants will undergo imaging using the PAM3 device. During the procedure, patients lie face down with one breast positioned in a water-filled aperture supported by a plastic cup. Infrared light is directed onto the breast, and movements in the water caused by light absorption by red blood cells are captured by ultrasound detectors to create a 3D image. This is a Phase 2 study conducted over about one year. Participants will be monitored for the performance of the PAM3 throughout the study period, including measures like sensitivity, specificity, positive predictive value, and patient satisfaction. Safety and system usability are also tracked. The study involves questionnaires to assess patient experience, and adverse events are recorded. The total involvement lasts approximately one year, with evaluations conducted during and after imaging sessions.