Clinical trial · Interventional
Combination With Gemcitabine in Advanced Pancreatic Cancer
A Multi-center, Phase I/II Study of BAY86-9766 in Combination With Gemcitabine in Patients With Locally Advanced Inoperable or Metastatic Pancreatic Cancer
- 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)
Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766 plus gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer. Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine (1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose. Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints: response duration, disease control rate, time to progression, progression-free survival, overall survival, safety and tolerability. Tumor assessments at Screening and than every 8 weeks.; Safety evaluations at Screening and weekly throughout the study; Safety follow-up visit 30 days after the last dose of study treatment; Survival follow up monthly for up to 8 month after LPFV.
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 |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BAY86-9766+Gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Drug: BAY86-9766+Gemcitabine
Primary outcomes (2)
- measure
- Number of Subjects With Dose Limiting Toxicities (DLT): Phase I
- timeFrame
- From randomization up to the first 8 weeks of therapy
- measure
- Tumor Response (Adjudicated Blinded Read Assessment): Phase II
- timeFrame
- From start of treatment until 134 weeks assessed every 8 weeks
Secondary outcomes (11)
- measure
- Tumor Response: Investigator Assessment: Phase I
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients ≥18 years of age * Histological or cytologically confirmed locally advanced, inoperable or metastatic pancreatic adenocarcinoma not amenable to curative radiotherapy or surgery * Patients must have at least one uni-dimensional measurable lesion by CT or MRI according to RECIST, Version 1.1 * Resolution of all acute toxic effects of any prior local treatment to Common Terminology Criteria for Adverse Events (CTCAE) Grade \</= 1 * Eastern Cooperative Oncology Group performance status (ECOG PS) \</= 2 * Patient has cardiac function, within normal range, as measured by an echocardiogram Exclusion Criteria: * Known history of, or symptomatic metastatic brain or meningeal tumors * History of cardiac disease * Active clinically serious infections * Clinically significant (ie. symptomatic) peripheral vascular disease * Pregnant or lactating women; women of childbearing potential not employing adequate contraception * Use of strong inhibitors or inducers of CYP3A4 * Prior systemic therapy for metastatic or locally advanced, unresectable pancreatic cancer, or other malignancy * Previous gemcitabine or 5-fluorouracil (5-FU) given concurrently as radiosensitizers to radiation therapy in adjuvant intention if given within 6 months from start of study treatment * Thrombotic or embolic events such within 6 months prior to start of study treatment
References
Publications (0)
Data not yet available