Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT04729205
Status:
TERMINATED
Last Update Posted:
2023-09-14
First Post:
2021-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Safety and Therapeutic Efficacy of Promitil in Combination With Folfox in Patients With GI Malignancies
Sponsor:
Lipomedix Pharmaceuticals Inc.
Organization:
Study Overview
Official Title:
An Open Phase 1B Study for Assessment of Safety and Therapeutic Efficacy of Promitil in Combination With Oxaliplatin-based Chemotherapy in Patients With Gastro-intestinal Malignancies
Status:
TERMINATED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigational drug not available
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This single center, Phase 1b, prospective, dose limiting toxicity (DLT)-clearing study, will assess the safety and efficacy of intravenously administered PROMITIL in combination with FOLFOX in cancer patients with inoperable, locally advanced or metastatic GI solid tumors.
Based on previous clinical results, we hypothesized that the addition of PROMITIL to FOLFOX, a treatment protocol consisting of oxaliplatin and fluoropyrimidine and commonly used to treat gastrointestinal (GI) malignancies, may enhance the overall efficacy of this combination regimen while maintain a reasonable safety profile.
Based on previous clinical results, we hypothesized that the addition of PROMITIL to FOLFOX, a treatment protocol consisting of oxaliplatin and fluoropyrimidine and commonly used to treat gastrointestinal (GI) malignancies, may enhance the overall efficacy of this combination regimen while maintain a reasonable safety profile.
Detailed Description:
Each patient will undergo screening, conducted up to 21 days before start of treatment, and receive 3 cycles of PROMITIL treatment, administered at four-week intervals, in combination with FOLFOX, administered at two-week intervals. Thereafter, patients may continue treatment with FOLFOX only, or with another regime at the investigator's discretion and will be followed up until death. Patients will be successively assigned, in order of accrual, to be concomitantly treated with PROMITIL and FOLFOX, at doses of PROMITIL meant to clear a dose of this combination treatment from DLT. Six patients will be treated with an initial DLT-clearing dose (Cohort 1). PROMITIL dose escalation from Cohort 1 to Cohort 2 will be authorized after 5 or 6 Cohort 1 patients complete their first two cycles of combination treatment with up to 1 DLT event reported for all 6 treated patients. If 2 or more Cohort 1 patients suffer from a DLT event in the first two cycles of treatment, 6 patients will be enrolled to Cohort -1 and treated with one dose level lower of PROMITIL. If 2 or more DLT events occur in Cohorts 2 or -1, the study will be discontinued for these patients and only patients in Cohort 1 will complete the study as planned. In any case, the total number of evaluable patients in the DLT-clearing phase will be no more than 12.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: