NCT02301143|CompletedPhase 2Results

Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC)

LAPACT

Nab-paclitaxel (Abraxane) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC): An International, Open-label, Multi-center, Phase 2 Study (LAPACT).

Celgene ClinicalTrials.gov

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1 other identifier

ABI-007-PANC-007

Study Type

interventional

Target

107

Locations

5 countries

Sites

Timeline

RegisteredNov 2014

StartedApr 2015

CompletionApr 2018

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

107

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Apr 2015

Typical duration for phase_2

Geographic Reach

5 countries

42 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

First Submitted

Initial submission to the registry

November 14, 2014

Completed

11 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed

5 months until next milestone

Study Start

First participant enrolled

April 21, 2015

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2017

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2018

Completed

9 months until next milestone

Results Posted

Study results publicly available

January 8, 2019

Completed

Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

2.6 years

First QC Date

November 14, 2014

Results QC Date

November 21, 2018

Last Update Submit

March 18, 2019

Conditions

Pancreatic Neoplasms

Keywords

Pancreatic NeoplasmsPancreatic CancerLocally advanced pacriatic cancernab-PaclitaxelAbraxaneGemcitabineABI-007

Outcome Measures

Primary Outcomes (1)

Kaplan-Meier Estimates for Time to Treatment Failure (TTF)
TTF was defined as the time after the first dose of study therapy to discontinuation of study therapy due to disease progression, death by any cause, or the start of a new non-protocol-defined anticancer therapy/surgery. If a participant does not progress, die or start a new non-protocol-defined anticancer therapy, the participant was censored on the last tumor assessment date. Tumor evaluations of CT or MRI scans were assessed by the investigative sites and response determined according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1. The definition for progressive disease (PD) was \>= 20% increase in the sum of diameters of target lesions from nadir, and the sum showed an absolute increase of \>= 5 mm; the progression of a non-target lesion or the appearance of any new lesions is also considered progression. Median and its 90% confidence interval (CI) of TTF were estimated using the method of Brookmeyer and Crowley.
Day 1 of study treatment up to 28.75 months; (maximum time for the last tumor assessment)

Secondary Outcomes (10)

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
Day 1 of study treatment up to the end of investigator choice period plus 28 days; up to 76.9 weeks
Overall Response Rate (ORR): Percentage of Participants With Complete (CR) or Partial Response (PR) According to RECIST Version 1.1
Day 1 of study treatment up to the end of investigator choice period plus 28 days; up to 76.9 weeks
Kaplan-Meier Estimate of Progression-Free Survival (PFS)
Day 1 of study treatment up to 28.75 months (maximum time for the last tumor assessment)
Kaplan-Meier Estimates for Overall Survival (OS)
Day 1 of study treatment up to 31.34 months (maximum time for survival follow-up)
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
Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit
+5 more secondary outcomes

Study Arms (1)

nab-Paclitaxel plus Gemcitabine

EXPERIMENTAL

nab-Paclitaxel 125 mg/m2 intravenous (IV) infusion over approximately 30 to 45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle Subjects who complete 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator will then determine the best option for the subject. * Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR * Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR * Surgical intervention

Drug: nab-PaclitaxelDrug: GemcitabineDrug: ChemoradiationDrug: CapecitabineProcedure: Surgery