Witten, Germany
Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
Phase
3Span
229 weeksSponsor
Greenwich LifeSciences, Inc.Witten
Recruiting
Non-interventional Study to Collect Real-world Clinical and Patient-reported Outcomes in Ovarian Cancer
Phase
N/ASpan
616 weeksSponsor
AstraZenecaWitten
Recruiting
Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC
Phase
3Span
474 weeksSponsor
OBI Pharma, IncWitten
Recruiting
FANTOM Post Market Clinical Trial
Phase
N/ASpan
366 weeksSponsor
REVA Medical, Inc.Witten
Recruiting
Witten
Recruiting
Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
This non-interventional study will be conducted to characterize the risks and benefits of bempedoic acid and/or its fixed-dose combination with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia and to gain insight into the effectiveness (managing plasma levels of low-density lipoprotein cholesterol) as well as safety (clinical events associated with the treatment modalities). Real world evidence will be collected in 5000 participants, treated by specialized as well as non-specialized physicians in hospitals and office based centers.
Phase
N/ASpan
242 weeksSponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyWitten
Recruiting
HIPEC + FLOT vs. FLOT Alone in Patients With Gastric Cancer and GEJ (PREVENT)
This is a multicenter, randomized, controlled, open-label study including patients with localized and locally advanced diffuse and mixed type adenocarcinoma of the stomach and Type II/III GEJ scheduled to receive perioperative chemotherapy combined with intraoperative HIPEC procedure. The scope of the trial is to evaluate the efficacy as well as the safety and tolerability of the combination of perioperative chemotherapy combined with an intraoperative HIPEC for resectable diffuse and mixed type gastric and GEJ (types II/III) adenocarcinoma. Intraoperative hyperthermic chemoperfusion is summarized under the abbreviation HIPEC in the following. Patients with localized and locally advanced diffuse or mixed type adenocarcinoma of the stomach and Type II/III GEJ (i.e. ≥cT3 any N or any T N-positive) with exclusion of distant metastases and after receiving neoadjuvant FLOT- therapy will be included in this trial after a central review. All enrolled patients will have received 3-6 pre-operative cycles (de-escalation or dose modification allowed) of biweekly FLOT (Docetaxel 50 mg/m² in 250 ml NaCl 0.9%, iv over 1 h; Oxaliplatin 85 mg/m² in 500 ml G5%, iv over 2h; Leucovorin 200 mg/m² in 250 ml NaCl 0.9%, iv over 30 min; 5-FU 2600 mg/m², iv over 24 h, q2wk) in the preoperative treatment phase. After completion of neoadjuvant FLOT- therapy followed by pre-operative tumor assessment, (also including diagnostic laparoscopy prior to start of FLOT), patients without disease progression (expected to be approximately 90% of the patients) will be included into the trial, stratified by initial clinical stage (N- vs. N+), histological type of tumor (Lauren classification diffuse vs. mixed) and study site. Patients will be randomized 1:1 to receive either postoperative FLOT (Arm A) or postoperative FLOT + intraoperative HIPEC (Arm B). Arm A (FLOT) Surgery in Arm A is planned to occur 4 to 6 weeks after d1 of last FLOT. Surgery is carried out in kind of gastrectomy, transhiatal extended gastrectomy. Following surgery, patients will receive four further 2-week treatment cycles FLOT in the post-operative treatment phase. Post-operative treatment should start 6 to 8 weeks, but at maximum 12 weeks after surgery. Arm B (FLOT/ HIPEC) Surgery in Arm B is planned to occur 4 to 6 weeks after d1 of last FLOT. Surgery is carried out in kind of gastrectomy, transhiatal extended gastrectomy. Surgery will be combined with an intraoperative Hyperthermic IntraPEritoneal Chemoperfusion (HIPEC) including cisplatin solution administered at a temperature of 42°C for 90 minutes. Following surgery, patients will receive four further 2-week treatment cycles FLOT in the post-operative treatment phase. Post-operative treatment should start 6 to 8 weeks, but at maximum 12 weeks after surgery. In both of the arms, tumor assessments (CT or MRI) are performed before randomization prior to surgery, and then every 3 months (radiological tumor assessment) thereafter until progression/relapse, death or end of follow-up. A change from CT into MRI in the follow up period is possible at any time. During treatment, clinical visits (blood cell counts, detection of toxicity) occur prior to every treatment dose. Safety of FLOT/ HIPEC will be monitored continuously by careful monitoring of all adverse events (AEs) and serious adverse events (SAEs) reported. The phase III design starts with a safety run-in phase. After 20 patients had curatively intended resection in Arm B, an interim safety analysis is performed that shows feasibility, safety, and tolerability of Arm B planned at the time 8 weeks after the 20th patient in Arm B had curatively intended resection. It is not planned to discontinue recruitment for the interim safety analysis.
Phase
3Span
333 weeksSponsor
Krankenhaus NordwestWitten
Recruiting
Therapy Online Plus (TOP+) - Comparing Two Online Interventions for Dealing With Challenging Life Circumstances
Phase
N/ASpan
159 weeksSponsor
Ulrike WillutzkiWitten, North Rhine-Westphalia
Recruiting
Construction of a Questionnaire on Panic Disorder and Agoraphobia
Phase
N/ASpan
196 weeksSponsor
Ulrike WillutzkiWitten, North Rhine-Westphalia
Recruiting
Capivasertib Plus Fulvestrant vs. Fulvestrant in Primary High-risk Lobular Breast Cancer
The evaluation of CCCA in the HR+/HER2- invasive lobular breast cancer patient population allows assessment of treatment efficacy with an achievable sample size of HR+/HER2- breast cancer patients within an acceptable and scientifically meaningful duration of recruitment. CCCA can be assessed immediately after last patients end of treatment. Central blinded pathological assessment of CCCA is planned in this study as a standardized preparation of the sampled tissue by the central pathologist. This pathologist is blinded regarding the study therapy administered, i. e. with or without capivasertib. The addition of capivasertib to fulvestrant in many clinical trials correlates with an improvement in PFS compared to fulvestrant alone in patients with HR+/HER2- locally advanced or metastatic breast cancer. This effect was observed regardless of a PI3K/AKT/mTOR pathway activation. None of the ongoing studies investigate the effects of the combined treatment in invasive lobular breast cancer. Given that these tumors are less likely to respond to chemotherapy, identification of patients that can be spared from chemotherapy is desirable. On the other hand, it is important to identify patients with invasive lobular breast cancer not responding to neoadjuvant ET who might be at increased risk for recurrence, who would therefore potentially benefit from further adjuvant therapies including chemotherapy. Given the high rates of PI3K pathway alterations in such tumors, it is expected that the CCCA rate could be increased by adding capivasertib to fulvestrant. GBG expect that the potential benefit of improved CCCA rate with a combination treatment compared to fulvestrant monotherapy would outweigh the potential risks due to added toxicity, which has already been shown in clinical trials to be well tolerated by patients.
Phase
2Span
91 weeksSponsor
GBG Forschungs GmbHWitten
Recruiting