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Assessment of Safety and Therapeutic Efficacy of Promitil in Combination With Folfox in Patients With GI Malignancies

NCT04729205 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-09-14

No results posted yet for this study

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.

Conditions

  • Cancer
  • Gastro-Intestinal Intraepithelial Neoplasia

Interventions

DRUG

Promitil

The first 6 patients recruited to the study will receive 1.6 mg/kg Promitil. Dose escalation to cohort 2 (PROMITIL dose of 2mg/kg) will be authorized after 5 or 6 patients of cohort 1 have completed the second cycle with DLT detected in fewer than two patients. If ≥2 patients of Cohort 1 develop DLT, dose escalation will be halted and Cohort -1 (PROMITIL dose of 1.2 mg/kg) will be opened. Should ≥2 patients in Cohort -1 or Cohort 2 experience DLT events, the study will be discontinued. In parallel, on days 1 and 15 of each cycle, patients will be treated with the mFOLFOX6 regime, which involves concurrent treatment with oxaliplatin 85 mg/m2 IV and leucovorin 200 mg/m2 IV, immediately followed by 5-FU 400 mg/m2 IV bolus, and then continuous infusion of 5-FU 1200 mg/m2/day, for 2 days (46-48 h).

Sponsors & Collaborators

  • Lipomedix Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Esther Tahover, MD · Shaare Zedek Medica Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-13
Primary Completion
2023-09-10
Completion
2023-09-12

Countries

  • Israel

Study Locations

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Entities

Diseases

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 NCT04729205 on ClinicalTrials.gov