Phase 1: testing Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days) for Pancreatic Adenocarcinoma
The main objective of this trial is to measure the whether it is safe and how hard side effects are to live with of sotorasib combined with first-line chemotherapy for advanced pancreatic adenocarcinoma harboring KRAS p.G12C mutation.
Official registry: https://clinicaltrials.gov/study/NCT06892054 · Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) · enrollment listed as 15
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days). The registry lists allocation as na. The main objective of this trial is to measure the whether it is safe and how hard side effects are to live with of sotorasib combined with first-line chemotherapy for advanced pancreatic adenocarcinoma harboring KRAS p.G12C mutation.
They plan to enroll about 15 people at 26 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocarcinoma With KRAS p.G12C Mutation
Interventions: Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days)
Primary outcome (registry wording): To evaluate the safety and tolerability of sotorasib combined with first-line chemotherapy for locally advanced or metastatic pancreatic adenocarcinoma harboring KRAS p.G12C mutation.
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Female of childbearing potential using a highly effective method of contraception (i.e., a method with less than 1% failure rate \[e.g., sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner\])
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility)
- Hemoglobin ≥ 9.0 g/dL (without transfusion within 2 weeks of laboratory test used to determine eligibility)
- Platelet count ≥ 100 x 109/L (without transfusion within 2 weeks of laboratory test used to determine eligibility)
- Aspartate aminotransferase (AST) and ALT ≤ 2.5 times the upper limit of normal (ULN) or ≤5 times if liver metastasis
- Serum bilirubin ≤ 1.5 x ULN
- International normalized ratio (INR) ≤ 1.5 x ULN. Prothrombin time (PT) ≤ 1.5 x ULN may be used instead of INR for sites whose laboratory do not report INR
Who the registry excludes
- Patients with resectable or borderline resectable pancreatic cancer
- Known history or positive viral test for human immunodeficiency virus (HIV)
- Peripheral sensory neuropathy. 4 )Proven complete dihydropyrimidine dehydrogenase (DPD) deficiency for patients that will be treated with mFOLFIRINOX
- 5\) Poor nutritional status (albumin \<3 g/L or weight loss \>10% during the last 4 weeks)
- 6\) Patients with known active hepatitis (i.e., Hepatitis B or C)
- Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible
- 12\) Significant gastrointestinal disorder that results in significant malabsorption, requirement for IV alimentation, or inability to take oral medication
Public study contact (from the registry)
Grupo de Tratamiento de los Tumores Digestivos
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
26 listed- Sainte Catherine - Institut Avignon Provence — Avignon, France, France (not_yet_recruiting)
- Chu Besançon - Hôpital Jean Minjoz — Besançon, France, France (not_yet_recruiting)
- Chu Brest - Hôpital Morvan — Brest, France, France (not_yet_recruiting)
- Chu de Lille - Claude Huriez — Lille, France, France (not_yet_recruiting)
- Hôpital Léon Berard — Lyon, France, France (not_yet_recruiting)
- Chu Bordeaux - Hôpital Haut Lévêque — Pessac, France, France (not_yet_recruiting)
- Chu Poitiers — Poitiers, France, France (not_yet_recruiting)
- Chu Reims - Hôpital Robert Debré — Reims, France, France (not_yet_recruiting)
- Chu Toulouse — Toulouse, France, France (not_yet_recruiting)
- Hôpital Paul-Brousse — Villejuif, France, France (not_yet_recruiting)
- Hospital Universitario Miguel Servet — Zaragoza, Aragon, Spain (recruiting)
- Hospital Clínic — Barcelona, Barcelona, Spain (recruiting)
FAQ about this NCT record
Is NCT06892054 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06892054?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06892054?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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