Clinical trial · Interventional
Metastatic Advanced Pancreas Sorafenib
A Randomized Phase II Study of Gemcitabine/Cisplatin With or Without Sorafenib to Evaluate the Efficacy and Safety in Patients With Locally Advanced or Metastatic Pancreatic Cancer. MAPS Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is multicentre, open-label, randomized, phase II trial in patients with locally advanced or metastatic pancreatic cancer. Subjects will be randomized in a 1:1 ratio to receive gemcitabine/cisplatin in combination with Sorafenib (arm A) or gemcitabine/cisplatin alone (arm B), as first-line chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabina, Cisplatino | Drug | — | UNRESOLVED |
| Sorafenib 400 mg po bid, continuously | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Sorafenib 400 mg po bid, continuously Gemcitabine 1000 mg/m2, Cisplatin 25 mg/m2 day 1, and 8 every 21 days.
- interventionNames
- Drug: Sorafenib 400 mg po bid, continuously
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Gemcitabine 1000 mg/m2, Cisplatin 25 mg/m2 day 1, and 8 every 21 days
- interventionNames
- Drug: Gemcitabina, Cisplatino
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- time from randomization date to date of local or regional relapse
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent prior to beginning protocol specific procedures * Male or female 18 to 75 years of age * Diagnosis of histologically confirmed adenocarcinoma of the pancreas * Locally advanced (non-resectable) or metastatic pancreatic cancer * Presence of at least one uni-dimensional indicator lesion measurable by CT scan or MRI in not an irradiated area (RECIST criteria) * Karnofsky performance status of ≥ 70 at study entry * Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL * Bilirubin level either normal or \< 1.5 x ULN * ASAT and ALAT ≤ 2.5 X ULN (≤ 5 x ULN if liver metastasis are present) * Serum creatinine \< 1.5 x ULN * Amylase and lipase ≤ 1.5 x the upper limit of normal * PT or INR and PTT \< 1.5 x upper limit of normal (subjects who receive anti-coagulation treatment with an agent such as warfarin or heparin will be allowed to participate provided that no evidence of underlying abnormality in these parameters exists). * Effective contraception for both male and female patients if the risk of conception exists Exclusion Criteria: * Brain metastases * Previous chemotherapy for locally advanced or metastatic pancreatic cancer. * Adjuvant therapy if documented recurrence is within 6 months after the end of adjuvant treatment) * Radiotherapy within 4 weeks prior to study entry * Major surgery within 4 weeks of first dose of study drug * Concurrent chronic systemic immune therapy * Any investigational agent(s) 4 weeks prior to entry * Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 6 months * Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months * Acute or subacute intestinal occlusion or history of inflammatory bowel disease * Known grade 3 or 4 allergic reaction to any of the components of the treatment * Known drug abuse/ alcohol abuse * Legal incapacity or limited legal capacity * Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent * Women who are pregnant or breastfeeding * Acute or subacute intestinal occlusion * Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial).
References
Publications (0)
Data not yet available