Phase 2
Completed N=184
A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer
Source: ClinicalTrials.gov NCT03086369 ↗Enrolled (actual)
184
Serious AEs
58.0%
Results posted
Jan 2022
Primary outcomePrimary: Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) — 0; 0; 0 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) |
0; 0; 0 | — |
| PRIMARY Phase 2: Overall Survival (OS) |
9.10; 10.81 | 0.7902 |
| SECONDARY Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab |
128; 86.3; 87.8; 112; 78.7; 172 | — |
| SECONDARY Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies |
— | — |
| SECONDARY Phase 1b: Overall Survival (OS) |
— | — |
| SECONDARY Phase 2: Progression-Free Survival (PFS) |
5.55; 6.41 | 0.3771 |
| SECONDARY Phase 1b/2: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) |
33.3; 14.3; 0; 30.5; 33.8 | — |
| SECONDARY Phase 1b/2: Duration of Response (DoR) |
NA; NA; 5.55; 5.55 | — |
| SECONDARY Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score" |
14.13; 6.11 | 0.017 sig |
| SECONDARY Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales. |
NA; 2.86; NA; NA; 2.79; 1.97 | 0.288 |
| SECONDARY Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L) |
0.8; 0.8; 0.8; 0.8; 70.1; 69.7 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03086369). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.