Clinical trial · Interventional
Study of Cobimetinib in Participants With Solid Tumors
A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of GDC-0973/XL518 Administered Orally Daily to Subjects With Solid Tumors
NCT00467779CI-TRIAL-00023669completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This non-randomized, open-label, study will determine the highest safe dose of cobimetinib, how often it should be taken, how well participants with cancer tolerate cobimetinib and will assess the pharmacokinetic effect of midazolam and dextromethorphan on the study drug.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cobimetinib | Drug | Cobimetinib | ALIAS |
| dextromethorphan | Drug | — | UNRESOLVED |
| midazolam | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Stage 1: Cobimetinib Dose Escalation (21/7 Schedule)
- description
- Participants will receive cobimetinib (GDC-0973/XL518) at the starting dose of 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment will continue until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
- interventionNames
- Drug: cobimetinib
- type
- EXPERIMENTAL
- label
- Stage 1A: Cobimetinib Dose Escalation (14/14 Schedule)
- description
- Participants will receive cobimetinib at the starting dose of 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment will continue until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
- interventionNames
- Drug: cobimetinib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival * Disease that is measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) * Adequate organ and marrow function * Sexually active participants must use medically acceptable methods of contraception during the course of the study and at least 11 days after the last dose of study treatment * Female participants of childbearing potential must have a negative serum pregnancy test at screening * No other history of/or ongoing malignancy that would potentially interfere with the interpretation of the pharmacodynamic or efficacy assays Exclusion Criteria: * Anticancer treatment (e.g., chemotherapy, radiotherapy, cytokines, or hormones) within 28 days (6 weeks for nitrosoureas or mitomycin C, or 14 days for hormonal therapy or kinase inhibitors) before the first dose of study drug * The participant has not recovered to Grade \</=1 from adverse events (AEs) or to within 10% of baseline values due to investigational or other agents administered more than 28 days prior to study enrollment * The participant has received another investigational agent within 28 days of the first dose of study drug * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia * The participant is pregnant or breastfeeding * The participant is known to be positive for the human immunodeficiency virus (HIV) * Allergy or hypersensitivity to components of the cobimetinib formulation
References
Publications (0)
Data not yet available
No reference posted for this study.