Phase 2
Completed N=56
Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
Source: ClinicalTrials.gov NCT02551991 ↗Enrolled (actual)
56
Serious AEs
60.7%
Results posted
Oct 2022
Primary outcomePrimary: Part 1A: Number of Participants With Dose-Limiting Toxicities (DLT) — 2; 1; 2; 0 Participants
Summary
This is an open-label, phase 2 non-comparative study to assess the safety, tolerability, and preliminary efficacy of nal-IRI in combination with other anticancer therapies in patients not previously treated for metastatic pancreatic adenocarcinoma. This study will assess the following regimen:
• nal-IRI + 5-fluorouracil (5-FU)/leucovorin (LV) + oxaliplatin
The study will be conducted in two parts:
Part 1, consisting of an initial dose exploration (Part 1A) followed by dose expansion (Part 1B) of the irinotecan liposome injection +5-FU/LV + oxaliplatin regimen and Part 2, consisting of a comparison of irinotecan liposome injection-containing regimen versus nab-paclitaxel plus gemcitabine. The comparative Part 2 was removed in a protocol amendment, dated 11 April 2018 (Version 6.0), before it was initiated, as this comparative part of the study is being undertaken as a stand-alone phase III study D-US-60010-001. This CSR only pertains to the single-arm dose exploration and dose expansion Part 1 results and no further reference is made to the comparative Part 2.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1A: Number of Participants With Dose-Limiting Toxicities (DLT) |
2; 1; 2; 0 | — |
| SECONDARY Median Progression Free Survival (PFS) |
9.7; 32.3; 9.2; 3.8; 9.2; 9.2 | — |
| SECONDARY Best Overall Response (BOR) |
2; 6; 4; 4; 20; 26 | — |
| SECONDARY Overall Response Rate (ORR) |
0; 42.9; 30.0; 14.3; 32.0; 34.4 | — |
| SECONDARY Disease Control Rate (DCR) |
42.9; 71.4; 40.0; 28.6; 72.0; 71.9 | — |
| SECONDARY Median Overall Survival (OS) |
12.6; 12.5; 16.6; 5.8; 12.7; 12.6 | — |
| SECONDARY Median Duration of Response (DoR) |
28.4; NA; 9.4; 9.4 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting
- Unresectable, locally advanced or metastatic disease; diagnosed within 6 weeks prior to screening
- At least one tumor lesion measurable by CT or MRI scan (according to RECIST v1.1)
- ECOG performance status of 0 or 1 at screening and within 72 hours prior to first dose if first dose occurs more than 72 hours post-screening
- Adequate hematological, hepatic, renal and cardiac function
- Recovered from the effects of any prior surgery or radiotherapy
- Patient has a Karnofsky performance status (KPS) ≥ 70 at Screening, and within 72 hours prior to date of first dose if first dose occurs more than 72 hours after screening (Part 1B only)
Exclusion Criteria
- Prior treatment of pancreatic cancer in the metastatic setting (or locally advanced setting) with surgery (placement of stent is allowed), radiotherapy, chemotherapy or investigational therapy
- Prior treatment of pancreatic cancer with chemotherapy in adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related toxicities present
- Uncontrolled Central Nervous System (CNS) metastases
- Clinically significant gastrointestinal disorder
- History of any second malignancy in the last 3 years. Patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible
- Presence of any contraindications for nal-IRI, irinotecan, 5-FU, leucovorin, oxaliplatin
- Use of strong CYP3A4 or inducers or presence of any other contra indications for irinotecan
- Pregnant or breast feeding
- Neuroendocrine or acinar pancreatic carcinoma
- Serum albumin < 3 g/dL at screening visit and within 72 hours prior to first dose if first dose occurs more than 72 hours post screening
- Patients with symptoms and signs of clinically unacceptable deterioration of primary disease at time of screening
- Previous treatment with irinotecan-based, nab-paclitaxel-based or gemcitabine-based resulting in disease progression
Data sourced from ClinicalTrials.gov (NCT02551991). 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.