A Study of MEHD7945A and Cobimetinib (GDC-0973) in Patients With Locally Advanced or Metastatic Cancers With Mutant KRAS
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2013 |
| End Date: | July 2017 |
| Contact: | Reference Study ID Number: GO29030 www.roche.com/about_roche/roche_worldwide.htm |
| Email: | global.rochegenentechtrials@roche.com |
| Phone: | 888-662-6728 (U.S. Only) |
A PHASE Ib, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MEHD7945A and GDC-0973 IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH MUTANT KRAS
This open-label, multicenter, global Phase Ib study will evaluate the safety, tolerability
and pharmacokinetics of MEHD7945A in combination with cobimetinib (GDC-0973) in patients
with locally advanced or metastatic solid tumors that carry a KRAS mutation. The study
comprises a dose-escalation and an indication-specific cohort expansion stage. Cohorts of
patients will receive MEHD7945A intravenously every two weeks and escalating doses of oral
cobimetinib for 21 consecutive days followed by 7 days off (28-day cycle). Study treatment
may be continued until disease progression or unacceptable toxicity occurs.
and pharmacokinetics of MEHD7945A in combination with cobimetinib (GDC-0973) in patients
with locally advanced or metastatic solid tumors that carry a KRAS mutation. The study
comprises a dose-escalation and an indication-specific cohort expansion stage. Cohorts of
patients will receive MEHD7945A intravenously every two weeks and escalating doses of oral
cobimetinib for 21 consecutive days followed by 7 days off (28-day cycle). Study treatment
may be continued until disease progression or unacceptable toxicity occurs.
Inclusion Criteria:
- Locally advanced or metastatic solid KRAS-mutant tumors, for which standard therapies
do not exist, have proven ineffective or intolerable or are considered inappropriate
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Evaluable disease or disease measurable per modified RECIST v1.1
- Consent to provide archival tumor tissue for biomarker testing
- Additionally, for patients who are considered for enrollment into the indication
specific expansion cohorts in Stage 2, the current cancer must be either KRAS-mutant
colorectal cancer (CRC) or KRAS-mutant non-small cell lung cancer (NSCLC)
Exclusion Criteria:
- History of prior significant toxicity from another MEK pathway inhibitor or
combination of another MEK and EGFR inhibitor requiring discontinuation of treatment
- Previous treatment with a combination of a MEK inhibitor with an EGFR inhibitor
(applies only to the indication specific expansion cohorts in Stage 2)
- Allergy or hypersensitivity to components of the cobimetinib formulations
- History of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic
antibodies that required discontinuation of therapy
- History of interstitial lung disease (ILD)
- Known severe ulcer disease
- History of or evidence of retinal pathology on ophthalmologic examination that is
considered a risk factor for neurosensory retinal detachment, CSCR, RVO, or
neovascular macular degeneration.
Patients will be excluded if they currently have either of the following conditions which
have been identified as risk factors for CSCR:
- Uncontrolled glaucoma with intraocular pressure >21 mmHg
- Grade >/= 3 hypertriglyceridemia.
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