Clinical trial NCT02941523 (phase 1/phase 2, status: unknown status)
Conditions: cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: nox66, carboplatin
SMILES: OC1=CC=C(C=C1)C1=CC2=C(OC1)C=C(O)C=C2, N[C@@H](CCCNC(N)=N)C(O)=O
Eligibility criteria:

        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 (β-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).