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Termination of the study was made after a full review of program data and assessment of the current risk-benefit profile.
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The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD7762 when given with the approved drug gemcitabine based on the side effects experienced by patients that receive both drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD7762 + gemcitabine | Other | AZD7762 administered alone and in combination with gemcitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD7762 | Drug | solution, intravenous, weekly |
| |
| gemcitabine |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram | Laboratory values weekly for all treatment cycles, and the other variables weekly for Cycle 0-1, then every cycle (3-4 weeks) from Cycle 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic effect of AZD7762 when administered alone and in combination with gemcitabine | According to protocol specified schedule, the number of PK samples collected during Cycle 0 and Cycle 1 | |
| Anti-tumor activity of AZD7762 when administered in combination with gemcitabine by assessment of Response Evaluation Criteria in Solid Tumors (RECIST) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Langmuir, MD | AstraZeneca | Study Director |
| Takashi Seto, MD, PhD | National Hospital Organization Kyushu Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Minamiku | Fukuoka | Japan |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C532363 | 3-(carbamoylamino)-5-(3-fluorophenyl)-N-(3-piperidyl)thiophene-2-carboxamide |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Drug |
intravenous, weekly |
|
|
| Every 2-3 cycles |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |