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| ID | Type | Description | Link |
|---|---|---|---|
| GO01300 | Other Identifier | Hoffmann-La Roche |
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This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of orally administered GDC-0941 administered once daily (QD) and twice daily (BID) in the treatment of advanced or metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: GDC-0941 QD Dose Escalation | Experimental | Participants will receive GDC-0941 for up to 1 year, administered orally QD at a starting dose of 15 milligrams (mg). |
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| Group B: GDC-0941 BID Dose Escalation | Experimental | Participants will receive GDC-0941 for up to 1 year, administered orally BID at a starting dose determined from Group A assessments. |
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| Group C: GDC-0941 QD or BID Expansion | Experimental | Participants will receive GDC-0941 for up to 1 year, administered orally QD or BID. The dose/regimen will be determined on the basis of data from Groups A and B. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0941 | Drug | GDC-0941 will be administered in escalating oral doses QD or BID in Groups A and B, respectively. In Group C, the dose/regimen will be determined on the basis of data from Groups A and B. The overall starting dose will be 15 mg administered in the first cohort enrolled in Group A. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of GDC-0941 | Pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72 h) Day 1; pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24 h) Days 8 and 15; pre-dose (5 min) Days 22, 29, 36, and end of Cycles 1 to 12 (up to 1 year overall) | |
| Terminal Elimination Half-Life (t1/2) of GDC-0941 | Pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72 h) Day 1; pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24 h) Days 8 and 15; pre-dose (5 min) Days 22, 29, 36, and end of Cycles 1 to 12 (up to 1 year overall) | |
| Area Under the Concentration-Time Curve (AUC) of GDC-0941 | Pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72 h) Day 1; pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24 h) Days 8 and 15; pre-dose (5 min) Days 22, 29, 36, and end of Cycles 1 to 12 (up to 1 year overall) | |
| Percentage of Participants with Adverse Events | Visits during treatment on Days 1, 2, 3, 4, 8, 15, 22, 29, 36; weekly during Cycle 2; every two weeks during Cycles 3 to 6; every month during Cycles 7 to 12; and up to 30 days after last dose (up to 1 year overall) | |
| Percentage of Participants with Dose-Limiting Toxicities (DLTs) | Visits during treatment on Days 1, 2, 3, 4, 8, 15, 22, 29, 36 | |
| Percentage of Participants with Grade 3 or 4 Abnormalities in Safety-Related Laboratory Parameters | Visits at Baseline and during treatment on Days 1, 8, 15, 22, 29, 36; weekly during Cycle 2; every two weeks during Cycles 3 to 6; every month during Cycles 7 to 12; and up to 30 days after last dose (up to 1 year overall) | |
| Time of Maximum Observed Concentration (Tmax) of GDC-0941 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Objective Response According to RECIST | Tumor assessments as Baseline, Day 36, and every 8 weeks thereafter through Cycle 12 (up to 1 year overall) | |
| Progression-Free Survival (PFS) According to RECIST | Tumor assessments as Baseline, Day 36, and every 8 weeks thereafter through Cycle 12 (up to 1 year overall) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerry Hsu, M.D. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale | Arizona | 85258 | United States | |||
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| Pre-dose (5 minutes [min]) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72 hours [h]) Day 1; pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24 h) Days 8 and 15; pre-dose (5 min) Days 22, 29, 36, and end of Cycles 1 to 12 (up to 1 year overall) |
| Percentage of Participants by Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | Tumor assessments as Baseline, Day 36, and every 8 weeks thereafter through Cycle 12 (up to 1 year overall) |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Detroit | Michigan | 48201 | United States |
| ID | Term |
|---|---|
| C532162 | 2-(1H-indazol-4-yl)-6-(4-methanesulfonylpiperazin-1-ylmethyl)-4-morpholin-4-ylthieno(3,2-d)pyrimidine |
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