Phase 2
N=16
Safety, PK and Efficacy of NOX66 as a Monotherapy and Combined With Carboplatin in Refractory Solid Tumours
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02941523 ↗Enrolled (actual)
16
Serious AEs
12.1%
Results posted
Jun 2021
Primary outcome: Primary: Number of Participants Who Experience Dose Limiting Toxicity (DLT) During NOX66 Monotherapy and During NOX66 Combination With Carboplatin — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NOX66 (Drug); Carboplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Noxopharm Limited
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experience Dose Limiting Toxicity (DLT) During NOX66 Monotherapy and During NOX66 Combination With Carboplatin |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events (SAEs) Related to NOX66. |
0; 0; 1; 0 | — |
| SECONDARY Objective Response Rate (ORR) at Cycle 3 and at Cycle 6 of Combination Therapy |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Overall Clinical Response Rate at Cycle 3 and at Cycle 6 of Combination Therapy |
4; 1; 7; 5 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent
- Male or female ≥18 years of age
- Histologic or cytologic confirmed locally advanced or metastatic cancer that has no standard therapeutic alternatives.
- ECOG Performance status 0-1
- A minimum life expectancy of 12 weeks
- 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 2 weeks), immunotherapy or following major surgery and any surgical incision should be completely healed
Exclusion Criteria
- Patients who are pregnant or breastfeeding.
- Uncontrolled infection or systemic disease.
- 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.
- 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 2 weeks).
- 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.
- No concurrent systemic chemotherapy or biologic therapy is allowed.
- Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both).
- History of solid organ transplantation.
- Psychiatric disorder or social or geographic situation that would preclude study participation.
- Known unsuitability for treatment with carboplatin including renal disease where there is impaired glomerular filtration rate (GFR).
Data sourced from ClinicalTrials.gov (NCT02941523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.