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The primary objective of this study is as follows:
The secondary objectives of this study are as follows:
The exploratory objective of this study is as follows:
In addition, subjects may be eligible to enter a Treatment Extension Period. The following information will be obtained from this part of the study:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XL647 | Drug | Administered orally as a solution with mass-based dosing in early cohorts or as 50-mg tablets at a fixed dose at the MTD. A minimum of 3 subjects was planned for each dosing cohort with dose escalation dependent on subject tolerance of the prior dose. During the Treatment Period, subjects in each cohort were administered a single dose of XL647 on Day 1 followed by a 72-hour period of observation. If there were no XL647-related dose limiting toxicities, subjects received 5 daily doses of XL647 on Days 4-8. Twenty-one days after the initial dose, in the absence of unacceptable toxicity or disease progression, subjects could enter a Treatment Extension Period that consisted of repeated 2-week cycles of five oral doses of XL647 followed by a 9-day observation period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses | First treatment until 30 days post last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the plasma pharmacokinetics of XL647 administered orally as a single dose and as repeat dose | At various time points between pre-treatment and post last treatment | |
| To estimate renal elimination of XL647 administered orally as a single dose in subjects with solid tumors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harold Keer, M.D., Ph.D. | Exelixis, Inc. (Study Sponsor) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94305 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30030583 | Background | Das M, Padda SK, Frymoyer A, Molina J, Adjei A, Lensing JL, Miles D, Sikic BI, Wakelee HA. A safety, tolerability, and pharmacokinetic analysis of two phase I studies of multitargeted small molecule tyrosine kinase inhibitor XL647 with an intermittent and continuous dosing schedule in patients with advanced solid malignancies. Cancer Chemother Pharmacol. 2018 Sep;82(3):541-550. doi: 10.1007/s00280-018-3646-0. Epub 2018 Jul 20. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C571826 | XL647 |
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| At various time points between pre-treatment and post last treatment |
| Rochester |
| Minnesota |
| 55905 |
| United States |