MedTrace Logo

A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer

NCT04229004 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 502

Last updated 2025-04-06

No results posted yet for this study

Summary

Precision Promise is a multi-center, seamless Phase 2/3 platform trial designed to evaluate multiple regimens in metastatic pancreatic cancer.

Primary Objectives

* To compare each investigational arm versus standard of care (SOC) for superiority in overall survival in first and/or second line metastatic ductal adenocarcinoma (metastatic pancreatic cancer) participants and determine which, if any, participants benefit from each investigational arm.

Secondary Objectives

* To determine short and long-term safety signals of each investigational arm in metastatic pancreatic cancer participants vs. SOC.
* To determine progression-free survival (PFS) for each investigational arm vs. SOC.
* To determine rates of overall response, CR, and PR; duration of overall response, CR or PR (whichever occurs first).
* To determine rates of clinical benefit; duration of clinical benefit.

Conditions

Interventions

DRUG

Gemcitabine combined with nab-paclitaxel

Arm is closed to recruitment. Nab-paclitaxel is infused over 30-40 min on days 1, 8, 15 of each 28-day cycle. Gemcitabine is infused over 30 min, immediately after completion of nab-paclitaxel infusion, on days 1, 8, 15 of each 28-day cycle. If one of the chemotherapy medications is held, the other study medications may be given. Doses should be re-adjusted if the participant's weight changes by +/- \>10%. If the participant's weight changes by \<10%, no adjustment is necessary unless the site has a standard procedure to adjust doses based upon current weight according to institutional guidelines.

DRUG

Dose -mFOLFIRINOX

Arm is closed to recruitment. The following are recommended parameters for infusion timing and sequence, although institutional variation in the administration of the regimen are permitted, as long as drug dosing and modification guidelines are followed. Oxaliplatin and leucovorin are administered concurrently over 30-120 minutes, followed by irinotecan over 30-90 minutes, followed by the infusion of 5-flurouracil. If one of the chemotherapy medications is held, the other study medications may be given. Doses should be re-adjusted if the participant's weight changes by +/- \>10%. If the participant's weight changes by \<10%, no adjustment is necessary unless the site has a standard procedure to adjust doses based upon current weight according to institutional guidelines.

DRUG

Dose - Pamrevlumab combined with gemcitabine and nab-paclitaxel

Arm is closed to recruitment. Pamrevlumab 35mg/kg IV - Cycle 1 (Day 1, 8, 15 of the 28 day cycle) and Cycle 2 and Onward (Day 1 and 15) Nab-paclitaxel 125mg/m2 IV - Day 1, 8, 15 for every 28 day cycle Gemcitabine 1000mg/m2 IV - Day 1, 8, 15 for every 28 day cycle

DRUG

Dose- Canakinumab and Spartalizumab combined with nab-paclitaxel and gemcitabine

Arm is closed to recruitment. Canakinumab 250mg SC- Day 1 of every 28 day cycle Spartalizumab 400 mg IV - Day 1 of every 28 day cycle Nab-paclitaxel 125mg/m2 IV - Day 1, 8, 15 of every 28 day cycle Gemcitabine 1000mg/m2 IV - Day 1, 8, 15 of every 28 day cycle

DRUG

Drug: Dose -SM-88

Arm is closed to recruitment. 460 mg (2 capsules) twice daily of a 28-day cycle along with the administration of methoxsalen, phenytoin and sirolimus.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2025-02-05
Completion
2025-02-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04229004 on ClinicalTrials.gov