Cancer Clinical Trial
Official title:
Phase Ia/Ib and Potential Phase IIa Study of the Safety and Pharmacokinetics of NOX66 Both as a Monotherapy and in Combination With Carboplatin in Patients With Refractory Solid Tumours
Verified date | May 2021 |
Source | Noxopharm Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study evaluates the safety and activity of NOX66 in patients with refractory solid tumors that are non responsive to standard therapies. This is a two part with a potential third part, open-label, multicenter, dose escalation study of NOX66 as monotherapy and in combination with carboplatin.
Status | Completed |
Enrollment | 19 |
Est. completion date | January 10, 2019 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Provision of informed consent 2. Male or female =18 years of age 3. Histologic or cytologic confirmed locally advanced or metastatic cancer that has no standard therapeutic alternatives. 4. ECOG Performance status 0-1 5. A minimum life expectancy of 12 weeks 6. Adequate bone marrow, hepatic and renal function as evidenced by: - Absolute neutrophil count (ANC) > 1.5 x 109/L - Platelet count > 100 x 109/L - Hemoglobin > 9.0 g/dL - Serum bilirubin < 1.5 x ULN - AST/ALT (SGOT/SGPT) 2.5 x ULN for the reference laboratory or < 5 x ULN in the presence of liver metastases - Serum creatinine 1.5 x ULN 7. Female patients who are known to be capable of conception should have a negative serum pregnancy test (beta-human chorionic gonadotropin (ß-hCG)) within 1 week of starting the study 8. All potentially fertile patients will agree to use an effective form of contraception during the study and for 90 days following the last dose of NOX66 (an effective form of contraception is defined as an oral contraceptive or a double barrier method 9. At least 4 weeks must have elapsed prior to commencement of NOX66 treatment since prior chemotherapy, investigational drug or biologic therapy and any toxicity associated with these treatments has recovered to = NCI-CTCAE Grade 1 10. At least 21 days must have elapsed prior to Day 1 Cycle 1 since radiotherapy (limited palliative radiation is allowed > 2 weeks), immunotherapy or following major surgery and any surgical incision should be completely healed Exclusion Criteria: 1. Patients who are pregnant or breastfeeding. 2. Uncontrolled infection or systemic disease. 3. Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease, angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months. 4. Patients with QTc of > 470 msec on screening ECG. (If a patient has QTc interval >470 msec on screening ECG, the screening ECG may be repeated twice (at least 24 hours apart). The average QTc from the 3 screening ECGs must be <470 msec in order for the patient to be eligible for the study. 5. Any major surgery, radiotherapy, or immunotherapy within the last 21 days (limited palliative radiation is allowed > 2 weeks). 6. Chemotherapy regimens with delayed toxicity within the last 4 weeks. Chemotherapy regimens given continuously or on a weekly basis with limited potential or delayed toxicity within the last 2 weeks. 7. No concurrent systemic chemotherapy or biologic therapy is allowed. 8. Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both). 9. History of solid organ transplantation. 10. Psychiatric disorder or social or geographic situation that would preclude study participation. 11. Known unsuitability for treatment with carboplatin including renal disease where there is impaired glomerular filtration rate (GFR). |
Country | Name | City | State |
---|---|---|---|
Georgia | Academician Z.Tskhakaia West Georgia National Center of Interventional Medicine" LTD/ Oncology Unit- JSC "EVEX Medical Corporation" group member | Kutaisi | |
Georgia | JSC, Neo Medi | Tbilisi | |
Georgia | LTD, Medulla Chemotherapy and Immunotherapy Clinic | Tbilisi | |
Georgia | Tbilisi State Medical University's First University Clinic, Department Of Oncology | Tbilisi |
Lead Sponsor | Collaborator |
---|---|
Noxopharm Limited |
Georgia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Who Experience Dose Limiting Toxicity (DLT) During NOX66 Monotherapy and During NOX66 Combination With Carboplatin | Dose limiting toxicity during monotherapy and combination therapy defined as any Grade 3 or more toxicity (by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE version 4.03]) (related to therapy) excluding Grade 3 or more neutropenia lasting greater than 5 days or thrombocytopenia associate with bleeding or Grade 4 thrombocytopenia. | Up to 1 month for NOX66 monotherapy from enrollment and up to 7 months from start of NOX66 combination therapy | |
Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events (SAEs) Related to NOX66. | An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related are events which had causal relationship to study drug as assessed by the Investigator and were suspected to be reasonably related to the study drug. | From enrollment through 30 days after the last cycle of therapy (8 months) | |
Secondary | Objective Response Rate (ORR) at Cycle 3 and at Cycle 6 of Combination Therapy | Objective response rate defined as the percentage of participants achieving a complete response (CR) and or partial response (PR) after treatment with NOX66 and carboplatin therapy as assessed by Response Evaluation Criteria in solid tumors (RECIST) v1.1. CR defined as disappearance of all target and non-target lesions and reduction of any pathological lymph nodes (whether target or non-target) to <10 mm in short axis; PR was defined by a 30% or more decrease in sum of longest diameter (SLD) of target lesions in reference to baseline. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and no new lesions. |
Radiological evaluation at baseline and at 3 months and at 6 months | |
Secondary | Overall Clinical Response Rate at Cycle 3 and at Cycle 6 of Combination Therapy | Overall Clinical response rate defined as the percentage of participants who achieved complete response (CR) or partial response (PR) or stable disease (SD) as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) criteria v1.1 after combination of NOX66 and carboplatin therapy. CR defined as disappearance of all target and non-target lesions and reduction of any pathological lymph nodes (whether target or non-target) to <10 mm in short axis; PR was defined by a 30% or more decrease in sum of longest diameter (SLD) of target lesions in reference to baseline. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. |
Radiological evaluation at baseline and at 3 months and at 6 months |
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