Clinical trial · Interventional
Phase 2, Nab Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Metastatic Pancreatic Cancer
A Phase 2, Randomized, Proof-of-Concept Study of Nab-Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Previously Untreated Metastatic Pancreatic Cancer
NCT02570711CI-TRIAL-00040241terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor Decision
Summary
Brief summary (as posted)
To evaluate the safety and efficacy of ACP-196 and nab paclitaxel/gemcitabine in subjects with previously untreated metastatic pancreatic cancer using standard response criteria
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 |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ACP-196 | Drug | Acalabrutinib | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Regimen 1
- description
- ACP-196 and nab-paclitaxel and gemcitabine
- interventionNames
- Drug: ACP-196
- Drug: Nab-paclitaxel
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- Regimen 2
- description
- Nab-paclitaxel and gemcitabine
- interventionNames
- Drug: Nab-paclitaxel
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women ≥ 18 years of age. * ECOG performance status of 0 or 1. * Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. * No previous radiotherapy, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. Exclusion Criteria: * Prior malignancy (other than pancreatic cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to \< 2 years. * Known central nervous system (CNS) metastases and/or carcinomatous meningitis. * Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening * Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass. * Biliary obstruction or presence of a percutaneous biliary drain. Note: Subjects with endobiliary stents may participate as long the enrollment criterion relating to serum bilirubin concentration is met. * Breastfeeding or pregnant
References
Publications (0)
Data not yet available
No reference posted for this study.