Status:
TERMINATED
Assessment of Safety and Therapeutic Efficacy of Promitil in Combination With Folfox in Patients With GI Malignancies
Lead Sponsor:
Lipomedix Pharmaceuticals Inc.
Conditions:
Cancer
Gastro-Intestinal Intraepithelial Neoplasia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
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, adm...
Eligibility Criteria
Inclusion
- Patients with histologically or cytologically confirmed diagnoses of GI malignancies, deemed incurable (inoperable and locally advanced or metastatic), and X-ray computed tomography (CT)-evaluable (measurable or non-measurable) disease, with or without contrast enhancement
- Patients must have one the following carcinomas (including adenocarcinomas, signet ring cell, and mucinous carcinomas) to be eligible to be included in the study:
- Esophagus (non-squamous) and GE junction
- Stomach
- Hepatocellular carcinoma
- Pancreas (exocrine) and ampulla
- Cholangiocarcinoma (intra-hepatic)
- Bile ducts and gall bladder
- Small bowel
- Large bowel
- Rectum
- Age 18-year or older
- ECOG Performance Status ≤ 2
- Estimated life expectancy of at least 3 months
- Adequate bone marrow function (absolute neutrophil count ≥1500/mm3, hemoglobin ≥9.5 g/dl, and a platelet count ≥100,000/mm3
- Adequate liver function (serum bilirubin ≤2.0 mg/100 ml; alanine aminotransferase ≤3× upper limit of normal \[ULN\], albumin ≥30 g/L, normal INR of prothrombin time (unless on coumadin treatment)
- Adequate renal function (serum creatinine ≤1.5 mg/100 ml or creatinine clearance ≥45 ml/min/1.73m2).
- A ≥21-day treatment-free interval from chemotherapeutic treatment, with the exception of 5-FU, capecitabine and biological therapies, where ≥14-day treatment-free intervals suffice.
- No other myelosuppressive treatment within 4 weeks of initiation of the study drug.
- No prior intravenous treatment with mitomycin-C, either alone or in combination
- No prior oxaliplatin treatment for inoperable locally advanced or metastatic disease
- A ≥6-month treatment-free interval from oxaliplatin, if given as adjuvant therapy or as neoadjuvant therapy for potentially operable disease
- No prior extensive radiotherapy (e.g., whole pelvis, total neuroaxis or greater than 50% of neuroaxis, whole abdomen, whole body or half body) or bone marrow transplantation with high-dose chemotherapy and/or total body irradiation.
- Women of child-bearing potential must be practicing an acceptable method of birth control.
- Understanding of study procedures and willingness to comply throughout the entire course of the study and to provide written informed consent
Exclusion
- Patients with squamous cell cancer, stromal tumor, sarcoma, neuroendocrine tumor
- Known hypersensitivity to the study drugs or to any of their components
- Cirrhosis (Child-Pugh Class C score)
- Serum albumin level \< 3.0 g/dl
- Any other severe concurrent disease, which in the judgment of the investigator, would make the subject inappropriate for entry into this study
- History of human immunodeficiency virus (HIV) infection
- History of chronic active hepatitis, including subjects who are carriers of hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Uncontrolled diabetes: HgbA1C≥7.5%,
- Presence of uncontrolled infection
- Evidence of active bleeding or bleeding diathesis
- Untreated (no surgery, no radiation) brain metastases, whether patient is symptomatic or asymptomatic. Patients with brain metastases treated by surgery or radiation who are stable and symptom-free requiring ≤4 mg dexamethasone/day, are eligible.
- Pregnant or lactating women
- Treatment with other investigational non-myelosuppressive drugs within 14 days of start of the study drug, and/or with myelosuppressive agents within 28 days of start of the study drug.
- Uncontrolled ascites (defined as 2 or more palliative taps within 30 days of screening
Key Trial Info
Start Date :
January 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04729205
Start Date
January 13 2021
End Date
September 12 2023
Last Update
September 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shaare Zedek Medical Center
Jerusalem, Israel, 91031