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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 June 2021 |
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Main ID: |
NCT02941523 |
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Date of registration:
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18/10/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety, PK and Efficacy of NOX66 as a Monotherapy and Combined With Carboplatin in Refractory Solid Tumours
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Scientific title:
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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 |
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Date of first enrolment:
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March 3, 2017 |
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Target sample size:
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19 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02941523 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Georgia
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Contacts
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Name:
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Graham Kelly |
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Address:
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Telephone:
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Email:
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Affiliation:
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Noxopharm Limited |
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Key inclusion & exclusion criteria
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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).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cancer
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Intervention(s)
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Drug: NOX66
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Drug: Carboplatin
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Primary Outcome(s)
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Number of Participants Who Experience Dose Limiting Toxicity (DLT) During NOX66 Monotherapy and During NOX66 Combination With Carboplatin
[Time Frame: Up to 1 month for NOX66 monotherapy from enrollment and up to 7 months from start of NOX66 combination therapy]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events (SAEs) Related to NOX66.
[Time Frame: From enrollment through 30 days after the last cycle of therapy (8 months)]
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Secondary Outcome(s)
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Objective Response Rate (ORR) at Cycle 3 and at Cycle 6 of Combination Therapy
[Time Frame: Radiological evaluation at baseline and at 3 months and at 6 months]
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Overall Clinical Response Rate at Cycle 3 and at Cycle 6 of Combination Therapy
[Time Frame: Radiological evaluation at baseline and at 3 months and at 6 months]
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Secondary ID(s)
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NOX66-001A
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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