Clinical trial · Interventional
A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer
A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Nab-Paclitaxel and Gemcitabine With or Without Olaratumab in the Treatment of First-Line Metastatic Pancreatic Cancer
NCT03086369CI-TRIAL-00059335completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine the safety and efficacy of nab-paclitaxel and gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic cancer.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Olaratumab | Drug | Olaratumab | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine
- description
- Participants received intravenous (IV) infusions of olaratumab 15 milligrams per kilogram (mg/kg), nab-paclitaxel 125 milligrams per meter square (mg/m\^2) and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
- interventionNames
- Drug: Olaratumab
- Drug: Nab-paclitaxel
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine
- description
- Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
- interventionNames
- Drug: Olaratumab
- Drug: Nab-paclitaxel
- Drug: Gemcitabine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological diagnosis of adenocarcinoma of the exocrine pancreas that is metastatic (Stage IV) and not amenable to resection with curative intent. * If present, clinically significant or symptomatic amounts of ascites should be drained prior to Day 1. * Have had no prior systemic treatment for metastatic disease. Prior adjuvant or neo-adjuvant chemotherapy or radiochemotherapy (other than nab-paclitaxel) is allowed if completed ≥3 months prior to enrollment and no lingering toxicities are present. * Prior radiation therapy for treatment of cancer is allowed to \<25% of the bone marrow. * Phase 2: archival tumor tissue or be willing to provide a pre-treatment biopsy. * Measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Discontinued all previous treatments for cancer ≥4 weeks prior. * Adequate organ function. * Life expectancy of at least 3 months. Exclusion Criteria: * Serious concomitant systemic disorder. * Have received first line treatment for metastatic pancreatic cancer. * Received prior treatment with nab-paclitaxel. * Have known central nervous system malignancy or metastasis. * Current hematologic malignancies. * Participated within the last 30 days in a clinical trial involving an investigational product. * Women with a positive pregnancy test or lactating. * Have endocrine pancreatic tumors or ampullary cancer. * Currently enrolled in another clinical trial. * Have a known additional malignancy that is progressing or required active treatment within the past 1 year. * Known allergy to nab-paclitaxel or gemcitabine or any ingredient of study drug formulations. * Are taking certain anti-coagulant medications such as warfarin and are unable to be switched to other similar medicines.
References
Publications (0)
Data not yet available
No reference posted for this study.