Phase 2
N=107
Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC)
Pancreatic Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT02301143 ↗Enrolled (actual)
107
Serious AEs
36.3%
Results posted
Jan 2019
Primary outcome: Primary: Kaplan-Meier Estimates for Time to Treatment Failure (TTF) — 9.0 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- nab-Paclitaxel (Drug); Gemcitabine (Drug); Chemoradiation (Drug); Capecitabine (Drug); Surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celgene
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan-Meier Estimates for Time to Treatment Failure (TTF) |
9.0 | — |
| SECONDARY Disease Control Rate (DCR): Percentage of Participants With Complete (CR) or Partial Response (PR), or Stable Disease (SD) for ≥ 16 Weeks According to RECIST Version 1.1 |
77.6 | — |
| SECONDARY Overall Response Rate (ORR): Percentage of Participants With Complete (CR) or Partial Response (PR) According to RECIST Version 1.1 |
39.3 | — |
| SECONDARY Kaplan-Meier Estimate of Progression-Free Survival (PFS) |
10.9 | — |
| SECONDARY Kaplan-Meier Estimates for Overall Survival (OS) |
18.8 | — |
| SECONDARY Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Global Health Status and 5 Functioning Scales |
43; 34; 18; 20; 66; 9 | — |
| SECONDARY Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Symptom Scales and Single Symptom Items |
46; 24; 25; 29; 64; 2 | — |
| SECONDARY Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): Six Summary Scales |
62; 33; 0; 49; 36; 10 | — |
| SECONDARY Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): Satisfaction With Health Care Scale |
42; 40; 13 | — |
| SECONDARY Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): 10 Individual Item Scores |
50; 42; 3; 20; 54; 21 | — |
| SECONDARY Participants With Treatment Emergent Adverse Events (TEAEs) |
105; 105; 102; 103; 85; 90 | — |
Summary
This clinical study is in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment. Subjects who complete the treatment will choose, with their treating physicians, what additional treatment should be given: more nab-Paclitaxel plus gemcitabine, Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer.
Eligibility Criteria
Inclusion Criteria
- Non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients
- No prior anticancer therapy for pancreatic cancer
•≥ 18 years of age with a performance status of 0 or 1•Adequate complete blood counts, hepatic function, and renal function
- Signed informed Consent
Exclusion Criteria
- Active bacterial, viral, or fungal infection
- Infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or receiving immunosuppressive or myelosuppressive
- Subjects with sensory neuropathy, ascites, or plastic biliary stent.
- Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders (including but not limited to connective tissue disorders, lung disease, and cardiac or seizure disorders)
- Women who are pregnant or breast feeding
Data sourced from ClinicalTrials.gov (NCT02301143). 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.