Not provided
Not provided
Not provided
Not provided
Not provided
PK results demonstrate low and variable plasma concentrations so that achieving therapeutic concentrations is unlikely.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD6918 based on the side effects experienced by patients with advanced solid malignancies that receive daily AZD6918 alone. It is possible that AZD6918 will be administered twice daily. Then maximum tolerated doses in combination with either gemcitabine or pemetrexed will also be investigated.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gemcitabine | Experimental | gemcitabine administered in combination with AZD6918 |
|
| pemetrexed | Experimental | pemetrexed administered in combination with AZD6918 |
|
| AZD6918 | Experimental | AZD6918 administered alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6918 | Drug | liquid suspension, daily, oral dose |
| |
| gemcitabine |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, Karnofsky performance status | Weekly for first two treatment cycles, then every 2-4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic effect of AZD6918 when administered alone and in combination with chemotherapy | According to protocol specified schedule, the number of PK samples collected during Cycle 1 (up to 28 days) based on treatment with AZD6918 alone or in combination with chemotherapy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Judith Ochs, MD | AstraZeneca | Study Director |
| Jeffrey Infante, MD | SCRI Development Innovations, LLC | Principal Investigator |
| Lia Gore, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aurora | Colorado | United States | |||
| Research Site |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
intravenous, doses are on an intermittent schedule |
|
|
| pemetrexed | Drug | intravenous, dose administered every 21-days |
|
|
| Nashville |
| Tennessee |
| United States |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |