A randomized, open label, multicenter phase II/III trial of sacituzumab govitecan compared to standard of care in metastatic, refractory colorectal cancer patients (TROPHIT1)
- Conditions
- Metastatic Colorectal cancer (mCRC)MedDRA version: 21.0Level: LLTClassification code: 10052362Term: Metastatic colorectal cancer Class: 10029104MedDRA version: 21.0Level: PTClassification code: 10052358Term: Colorectal cancer metastatic Class: 100000004864Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-509771-17-00
- Lead Sponsor
- niversitaetsklinikum Heidelberg AöR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Diagnosis of UICC Stage IV mCRC, not eligible for local therapy, Women or men aged = 18 years, no upper age limit, ECOG performance status =2, Patients must have failed standard therapy or were intolerable towards standard therapy which must include fluoropyrimidine, oxaliplatin and irinotecan. (Targeted therapies (in combination with chemotherapy) including antiangiogenic monoclonal antibody/fusion protein/small molecule (e.g. bevacizumab, aflibercept, ramucirumab) and anti-EGFR antibody (e.g. Cetuximab, Panitumumab) are allowed as previous therapies.), No Irinotecan treatment within the last 6 months. Patients that received Irinotecan treatment more than 6 months prior to inclusion, must have been responsive to Irinotecan induction therapy (i.e., patients previously exposed to induction chemotherapy containing irinotecan must have presented CR or PR or else SD at least 3 months or at initial response assessment)., At least one measurable lesion according to RECIST 1.1 that can be accurately assessed at screening by computed tomography or magnetic resonance imaging and is suitable for repeated assessment or available CT scan of thorax and abdomen not older than 30 days before start of treatment (day 1 of cycle 1).
Patient with a known hypersensitivity to any of the excipients of sacituzumab govitecan, Known microsatellite instable (MSI-H) / MMR-protein deficient (dMMR) colorectal cancer., Pregnancy and lactation, Participation in other clinical trials involving an investigational drug(s) (Phases 1-4) or observation period of competing trials, respectively within 4 weeks prior to study entry. Patients participating in observational studies are eligible., Taking medications that may interfere with SN-38 metabolism., Have had a prior anticancer biologic agent within 2 weeks prior to enrollment or have had prior chemotherapy, targeted therapy, or radiation therapy within 2 weeks prior to enrollment AND have not recovered (ie, = Grade 2 is considered not recovered) from AEs at the time of study entry., Have not recovered (ie, = Grade 2 is considered not recovered) from AEs due to a previously administered agent., Have an active second malignancy., History of significant cardiovascular disease ( NYHA = III), Clinical signs of active severe infection with or without requiring antibiotics., Inadequate bone marrow, renal, and hepatic function defined by laboratory tests within 14 days prior to study treatment (growth factor support is not allowed within 14 days prior to baseline labs
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method