Intravenously Administered Liposomal PROMITIL in Combination With External Beam Radiotherapy in Cancer Patients

Launched by LIPOMEDIX PHARMACEUTICALS INC. · Jan 29, 2019

Keywords

ClinConnect Summary

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/kg) in Cohort 2 and a further increase 1.8 mg/kg in Cohort 3 in the absence of DLTs after two treatment cycles, with an interluding 10-fraction course of radiotherapy.

PROMITIL will be intravenously delivered on Day 1 of each of the two 21-day cycles.

Cohort 1: The first 6 patients recruited to the study will receive 1.25 mg/kg PROMITIL.

Cohort 2: If no dose-limiting toxicities (DLTs) are r...

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Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. 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.
• • 3. No prior intravenous treatment with mitomycin-C either alone or in combination
• • 4. 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.
• • 5. No prior radiotherapy to the same anatomic site aimed for radiotherapy.
• • 6. Age ≥18years
• • 7. BMI: 18-36
• • 8. ECOG Performance Status ≤ 2
• • 9. Estimated life expectancy of at least 3 months
• • 10. Adequate bone marrow function (an absolute neutrophil count ≥1500/mm3, hemoglobin ≥9.5 g/dl, and a platelet count ≥100,000/mm3);
• • 11. Adequate liver function (serum bilirubin ≤2.0 mg/100 ml; alanine aminotransferase ≤3× ULN, albumin ≥34g/L)
• • 12. Adequate renal function (serum creatinine ≤1.5 mg/100 ml or creatinine clearance ≥40 ml/min/1.73m2)
• • 13. Women of child-bearing potential practicing an acceptable method of birth control.
• • 14. Understanding of study procedures and willingness to comply for the entire length of the study and to provide written informed consent
• Exclusion Criteria:
• • 1. Known hypersensitivity to the study drug or to any of its components
• • 2. Prior intravenous treatment with mitomycin C
• • 3. Patients requiring whole-brain irradiation
• • 4. Patients requiring re-irradiation of the same tumor/anatomical site.
• • 5. CHF (NYHA = Class IV)
• • 6. Severe COPD or Stage ≥3 severe emphysema with FEV1 between 30 and 50 percent of normal
• • 7. Chronic liver disease or cirrhosis with Child-Pugh Class C score
• • 8. Any other severe concurrent disease which in the judgment of the investigator would make the subject unsuitable for entry into this study
• • 9. History of human immunodeficiency virus (HIV) infection
• • 10. 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.
• • 11. Presence of uncontrolled infection.
• • 12. Evidence of active bleeding or bleeding diathesis
• • 13. Pregnant or lactating
• • 14. Treatment with other investigational drugs within \<21 days of start of day 1 of study drug.
• • 15. Uncontrolled ascites (defined as 2 or more palliative taps in the last 21 days before screening).
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