Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
Keywords
Abstract
Dates
| Last Verified: | 02/29/2020 |
| First Submitted: | 09/09/2015 |
| Estimated Enrollment Submitted: | 09/14/2015 |
| First Posted: | 09/15/2015 |
| Last Update Submitted: | 03/29/2020 |
| Last Update Posted: | 03/30/2020 |
| Actual Study Start Date: | 08/31/2015 |
| Estimated Primary Completion Date: | 10/27/2020 |
| Estimated Study Completion Date: | 10/27/2020 |
Condition or disease
Intervention/treatment
Drug: nal-IRI + 5-FU/LV + oxaliplatin
Drug: nal-IRI + 5-FU/LV + oxaliplatin
Drug: nal-IRI + 5-FU/LV + oxaliplatin
Drug: nal-IRI + 5-FU/LV + oxaliplatin
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: nal-IRI + 5-FU/LV + oxaliplatin | Drug: nal-IRI + 5-FU/LV + oxaliplatin |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Safety by reporting the adverse events and serious adverse events [Up to 18 months]
2. Determine dose limiting toxicities (DLT) [Up to 28 Days post first treatment]
Secondary Outcome Measures
1. Pharmacokinetic Cmax of total irinotecan, SN-38 and oxaliplatin [Day 1 Predose, Day 1 at 1.5 hours (irinotecan and SN-38 only), Day 1 at 5.5 hours, Day 3, Day 8, Day 15, Day 30 Post last dose]
2. Pharmacokinetic Cavg of total irinotecan, SN-38 and oxaliplatin [Day 1 Predose, Day 1 at 1.5 hours (irinotecan and SN-38 only), Day 1 at 5.5 hours, Day 3, Day 8, Day 15, Day 30 Post last dose]
3. Pharmacokinetic Cmin of total irinotecan, SN-38 and oxaliplatin [Day 1 Predose, Day 1 at 1.5 hours (irinotecan and SN-38 only), Day 1 at 5.5 hours, Day 3, Day 8, Day 15, Day 30 Post last dose]
4. Pharmacokinetic AUCt of total irinotecan, SN-38 and oxaliplatin [Day 1 Predose, Day 1 at 1.5 hours (irinotecan and SN-38 only), Day 1 at 5.5 hours, Day 3, Day 8, Day 15, Day 30 Post last dose]
5. Pharmacokinetic CL of total irinotecan, SN-38 and oxaliplatin [Day 1 Predose, Day 1 at 1.5 hours (irinotecan and SN-38 only), Day 1 at 5.5 hours, Day 3, Day 8, Day 15, Day 30 Post last dose]
6. Pharmacokinetic Vd of total irinotecan, SN-38 and oxaliplatin [Day 1 Predose, Day 1 at 1.5 hours (irinotecan and SN-38 only), Day 1 at 5.5 hours, Day 3, Day 8, Day 15, Day 30 Post last dose]
7. Progression Free Survival (PFS) [up to 16 weeks post first treatment]
8. Overall Survival (OS) [up to 16 weeks post first treatment]
9. Overall Response Rate (ORR) [up to 16 weeks post first treatment]
10. Disease Control Rate (DCR) [up to 16 weeks post first treatment]
11. Safety and adverse event profile [up to 18 months]
