Clinical trialPhase 1 / Phase 2Terminated
QUILT-3.010: A Study of Gemcitabine and Nab-paclitaxel With or Without NPC-1C to Treat Patients With Pancreatic Cancer
A Multicenter Phase I/II Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel With or Without NPC-1C in Patients With Metastatic or Locally Advanced Pancreatic Cancer Previously Treated With FOLFIRINOX
- Outcome
- Stopped earlyDSMB terminated the trial for futility. (Efficacy or futility)
- Phase
- Phase 1 / Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- April 2013
- Expected end
- December 2019
- Enrollment
- 81 participants
- Sites
- 12
- Primary outcomes
- Safety and Tolerability; Overall Survival
- Sponsor
- Industry
- Results posted
- 2025-05-07
- Last update
- 7 May 2025
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Brief summary public domain (ClinicalTrials.gov)
This was a Phase 1/2 multi-institution prospective open label study in which subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer who previously received treatment with chemotherapy with FOLFIRINOX or FOLFIRINOX-like regimen received the investigational agent NEO-102 (NPC-1C). The Phase 1 portion of this study evaluated the safety of NEO-102 in combination with Gemcitabine in a dose de-escalation design with a starting dose of 1.5 mg/kg/dose. If 2 of 6 patients experience DLT, the dose will be de-escalated to 1 mg/kg/dose to evaluate the safety of NEO-102 in combination with Gemcitabine. . In the Phase 2 portion patients were randomized into one of two arms: A: NPC-1C with gemcitabine and nab-paclitaxel or B: gemcitabine and nab-paclitaxel
Detailed description public domain (ClinicalTrials.gov)
During Part 1 of the study, the safe and tolerable dose of NEO-102 in combination with Gemcitabine will be determined using a dose de-escalation design. The starting dose of NEO-102 is 1.5 mg/kg/dose (Dose level 1). If 2 of 6 patients experience a DLT at the starting dose, the dose of NEO-102 will be de-escalated to 1 mg/kg/dose, and up to 6 patients will be treated at this Dose Level -1. Upon completion of the phase I study up to 90 patients be randomized to one of two arms: A: Patients will receive NPC-1C(NEO-102) infusion at the safe dose, and nab-paclitaxel (125 mg/m2 as a 30 minute infusion, maximum infusion time not to exceed 40 minutes) followed by gemcitabine (1000 mg/m2 as a 30 minute infusion) for 3 consecutive weeks (on Day 1, 7 and 15 ) followed by a week of rest (for a 28 day cycle). OR B: Patients will receive on Day 1, 7 and 15 nab-paclitaxel (125 mg/m2 as a 30 minute infusion, maximum infusion time not to exceed 40 minutes) followed by gemcitabine (1000 mg/m2 as a 30 minute infusion) for 3 consecutive weeks (on Day 1, 7 and 15). NPC-1C(NEO-102) infusion at a dose of 1.5mg/kg IV 30 minutes following the completion of the gemcitabine on days 1 and 15 of the 28 day cycle.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Safety and Tolerability [28 days]. Count Of Participants, Participants. Phase 1-Dose Finding Dose Level 1 (n=3): 0; Arm A: Abraxane, Gemcitabine, NPC-1C (n=38): 3; Arm B: Abraxane, Gemcitabine (n=40): 7.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Overall Survival [From 1st dose of study therapy until death in participants in Phase 2.]. Median, Number of months survival (95% Confidence Interval). Arm A: Abraxane, Gemcitabine, NPC-1C (n=38): 6.6 (4.7 to 8.4); Arm B: Abraxane, Gemcitabine (n=40): 5 (3.3 to 6.5).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression Free Survival [Time from the 1st dose of study drug until progression in patients in Arm A]. Median, Median number of months without PD (95% Confidence Interval). Arm A (n=38): 3.5 (2.0 to 5.6); Arm B (n=40): 2.7 (1.9 to 4.1).