Status:
COMPLETED
Intravenously Administered Liposomal PROMITIL in Combination With External Beam Radiotherapy in Cancer Patients
Lead Sponsor:
Lipomedix Pharmaceuticals Inc.
Conditions:
Cancer
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This will be a multi-center, open-label, single-arm, prospective study, in which up to 18 adult patients requiring radiotherapy for metastatic disease or for an inoperable primary tumor with no defini...
Detailed Description
As combination with radiotherapy is expected to provide an additive or synergistic effect, the current dose-escalation study will begin with a dose of 1.25 mg/kg, to be followed by an increase (1.5 mg...
Eligibility Criteria
Inclusion
- Patients with histologically or cytologically confirmed recurrent and/or metastatic, cancer, with at least one measurable lesion (≤10 cm diameter) on file, and with no definitive curative treatment option.
- A ≥21-day treatment-free interval from last chemotherapeutic treatment (including cytotoxic or non-cytotoxic myelosuppressive agents), and ≥14-day treatment-free interval from biological therapies consisting of CDK 4/6 inibitiors, PARP inhibitors, m-TOR inhibitors Hormonal therapies including LH-RH analogs or anagonists, tamoxifen, aromatase inhibitors, bicalutamide, aboraterone, corticosteroids, or enzalutamide may be continued uninterruptedly.
- No prior intravenous treatment with mitomycin-C either alone or in combination
- No prior extensive radiotherapy (e.g., whole pelvis, or greater than 50% of neuroaxis, whole abdomen, whole body or half-body) or bone marrow transplantation with high dose chemotherapy.
- No prior radiotherapy to the same anatomic site aimed for radiotherapy.
- Age ≥18years
- BMI: 18-36
- ECOG Performance Status ≤ 2
- Estimated life expectancy of at least 3 months
- Adequate bone marrow function (an 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× ULN, albumin ≥34g/L)
- Adequate renal function (serum creatinine ≤1.5 mg/100 ml or creatinine clearance ≥40 ml/min/1.73m2)
- Women of child-bearing potential practicing an acceptable method of birth control.
- Understanding of study procedures and willingness to comply for the entire length of the study and to provide written informed consent
Exclusion
- Known hypersensitivity to the study drug or to any of its components
- Prior intravenous treatment with mitomycin C
- Patients requiring whole-brain irradiation
- Patients requiring re-irradiation of the same tumor/anatomical site.
- CHF (NYHA = Class IV)
- Severe COPD or Stage ≥3 severe emphysema with FEV1 between 30 and 50 percent of normal
- Chronic liver disease or cirrhosis with Child-Pugh Class C score
- Any other severe concurrent disease which in the judgment of the investigator would make the subject unsuitable 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), unless adequately treated and shown to be serum virus-free.
- Presence of uncontrolled infection.
- Evidence of active bleeding or bleeding diathesis
- Pregnant or lactating
- Treatment with other investigational drugs within \<21 days of start of day 1 of study drug.
- Uncontrolled ascites (defined as 2 or more palliative taps in the last 21 days before screening).
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Key Trial Info
Start Date :
January 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03823989
Start Date
January 3 2019
End Date
December 30 2021
Last Update
January 6 2022
Active Locations (3)
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1
Assuta Ashdod
Ashdod, Israel, 7747629
2
Hadassah Medical Center
Jerusalem, Israel, 9112001
3
Assuta Medical Center
Tel Aviv, Israel, 6971028