Phase 1
Completed N=25
Investigate the Safety and Tolerability of AZD6244 Monotherapy or + Docetaxel in Japanese Patients With Advanced Solid Malignancies or Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT01605916 ↗Enrolled (actual)
25
Serious AEs
16.0%
Results posted
Jul 2016
Primary outcomePrimary: Cmax of Selumetinib After Single Dose — 2534; 1073; 370.3; 897.1 ng/mL
Summary
The objective of this study will be to investigate the safety and tolerability of AZD6244 given monotherapy or in combination with docetaxel as 2nd line therapy in Japanese patients with Advanced Solid Malignancies or Locally Advanced or Metastatic Non-Small Cell Lung Cancer. In addition, the pharmacokinetic profile of AZD6244 will be investigated. Following the combination regimen dose escalation phase (Part A) of the study additional patients may be enrolled to a dose expansion phase (Part B) to refine further the safety, tolerability, pharmacokinetics and biological activity of the combination in this patient population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax of Selumetinib After Single Dose |
2534; 1073; 370.3; 897.1; 2084 | — |
| PRIMARY Tmax of Selumetinib After Single Dose |
1.49; 1.00; 1.74; 1.51; 0.98 | — |
| PRIMARY AUC(0-12) of Selumetinib After Single Dose |
6784; 1599; 1021; 2723; 5578 | — |
| PRIMARY Cmax of N-desmethyl Selumetinib After Single Dose |
130.8; 68.61; 27.50; 46.55; 136.6 | — |
| PRIMARY Tmax of N-desmethyl Selumetinib After Single Dose |
1.75; 1.00; 1.74; 1.75; 1.47 | — |
| PRIMARY AUC(0-12) of N-desmethyl Selumetinib After Single Dose |
409.6; 159.6; 88.79; 182.6; 495.4 | — |
| PRIMARY Cmax of Selumetinib During Oral Twice Daily Dose of Selumetinib |
2437; 662.3; 623.4; 1012; 2178 | — |
| PRIMARY Tmax of Selumetinib During Oral Twice Daily Dose of Selumetinib |
3.97; 1.25; 1.23; 1.96; 1.50 | — |
| PRIMARY AUC(0-12) of Selumetinib During Oral Twice Daily Dose of Selumetinib |
13050; 2334; 2130; 4818; 8734 | — |
| PRIMARY Cmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib |
38.91; 34.46; 36.16; 42.18; 84.56 | — |
| PRIMARY Tmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib |
3.97; 1.25; 1.25; 1.96; 1.74 | — |
| PRIMARY AUC(0-12) of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib |
241.5; 150.4; 146.3; 251.3; 445.0 | — |
| SECONDARY Cmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2 |
2329; 2726 | — |
| SECONDARY Tmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2 |
0.99; 0.99 | — |
| SECONDARY AUC(0-12) of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2 |
2422; 3056 | — |
Eligibility Criteria
Inclusion Criteria
- Patients diagnosed with lung cancer who have not responded to prior therapy or have become worse.
- Patients who have overall good general conditions.
- Patients who have at least one lesion that can be accurately assessed by imaging.
- Patients who have appropriate renal conditions confirmed by test results for taking part in the study.
- Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status.
Exclusion Criteria
- Patients with brain metastases or spinal cord compression.
- Patients with significant abnormal ECG findings.
- Patients with evidence of severe or uncontrolled systemic disease.
- The main organ functional test values for bone marrow, kidney, and liver, etc., do not meet the standards.
- Patients with known hypersensitivity to docetaxel or products containing polysorbate 80.
Only for monotherapy cohort eligibility criteria Patients with advanced solid malignancies refractory to standard treatment or for which no standard therapy exists irrespective of the stage and previous treatment.
Patients with histologically or cytologically confirmed advanced solid malignancies.
Data sourced from ClinicalTrials.gov (NCT01605916). 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. Informational only — not medical advice.