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Compound development discontinued
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This is Phase I, open-label and dose escalation study to evaluate the safety and tolerability of AZD1480(JAK2 inhibitor) in Asian patients with advanced solid tumors (Part A and C) and in patients with advanced HCC (Part B) in the escalation phase, EGFR or ROS mutant NSCLC and non-smokers with lung metastasis and gastric cancer in the expansion phase and to evaluate daily and BID dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Daily dosing of AZD1480 to the patients with solid tumours excluding HCC |
|
| Part B | Experimental | BID dosing of AZD1480 to the patients with advanced HCC (Child-Pugh A to B7) |
|
| Part C | Experimental | BID dosing of AZD1480 to the patients with solid tumours excluding HCC |
|
| Expansion | Experimental | BID dosing of AZD1480 to the patients with EGFR or ROS mutant NSCLC and non-smokers with lung metastasis and gastric cancer and solid tumour with biopsy available. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1480 Daily | Drug | Oral Dose, Capsule, Daily Dosing |
| |
| AZD1480 BID |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the safety and tolerability of AZD1480 | Safety and tolerability monitoring will proceed for whole study period. Screening, Cycle1Day1, Cycle1Day5 (only for Part B), Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle2Day8 and Day1 of further Cycles, IP discontinued visit and 30-days follow up |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetics (PK) of AZD1480 following single dose and multiple doses | Part A and Expansion - 12 times during Cycle 1, 11 times during Cycle 2. Part B and C - 11 times during Cycle 1, 10 times during Cycle 2. *1 additional PK sample in Cycle 1 will be collect for optional biopsy sample collected patients. | |
| To obtain a preliminary assessment of the anti-tumour activity of AZD1480 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Becker Hewes, MD | AstraZeneca | Study Director |
| Kang Yoon-Koo, MD, PhD | Asian Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Seoul | South Korea |
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| Drug |
Oral Dose, Capsule, BID Dosing |
|
| Tumour response assessment by RECIST (Response Evaluation Criteria In Solid Tumors) version 1.1 every 6 weeks |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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