Safety, Tolerability, and Pharmacokinetics of Onartuzumab Combined With Vemurafenib and/or Cobimetinib in Cancer Patients

Withdrawn before enrolling · Phase 1

Conditions studied: Neoplasms

In brief

This study will evaluate the maximum tolerated dose and dose-limiting toxicities of vemurafenib and/or cobimetinib when used with onartuzumab in cancer patients.

Key facts

Study ID

NCT01974258

Run by

Hoffmann-La Roche

People needed

0

Starts

2014-02-01

Expected to finish

2014-07-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients >/= 18 years of age.
• Patients with histologically confirmed, BRAFV600-mutant, unresectable, locally advanced or metastatic solid malignancies. OR
• Patients with a histologically confirmed, KRAS-mutant, Stage IV colorectal adenocarcinoma, or KRAS-mutant metastatic non-small-cell lung carcinoma. OR
• Patients with histologically confirmed BRAFV600-mutant unresectable Stage IIIC or Stage IV metastatic melanoma.
• Valid MET IHC test result.
• Measurable disease per Response Evaluation Criteria in Solid Tumors v1.1
• ECOG performance status of 0 or 1.
• For BRAFV600-mutant cancers:
• Previously untreated for their melanoma or previously treated for their melanoma but without prior exposure to any HGF, MET, BRAF, or MEK inhibitor therapy
• BRAFV600-mutant solid malignancies other than melanoma for which standard therapy does not exist has proven to be ineffective or intolerable or is considered inappropriate.
• Patients must not have had prior exposure to HGF, MET, BRAF, or MEK inhibitor therapy.
• For KRAS-mutant cancers:
• mCRC patients must have received therapeutic regimens including oxaliplatin, irinotecan, 5-FU, and bevacizumab, or determined to be ineligible for these treatments. Patients must not have had prior exposure to HGF, MET, BRAF, or MEK inhibitor therapy.
• Metastatic NSCLC patients must have received platinum-based doublet chemotherapy or determined to be ineligible for this regimen. Patients must not have had prior exposure to HGF, MET, BRAF, or MEK inhibitor therapy.
• Consent to provide tumor tissue for biomarker analyses.
• Life expectancy >/= 12 weeks.
• Fully recovery from the effects of any major surgery or significant traumatic injury within 14 days from the first dose of study treatment.
• Adequate hematologic and end organ function, as defined by clinical laboratory results.
• Use of effective form(s) of contraception as defined by protocol during the course of this study and for at least 6 months after study drug discontinuation.

You may not qualify if…

• Palliative radiotherapy or experimental therapy within 28 days prior to first dose of study drug treatment.
• Major surgical procedure or significant traumatic injury from 28 days prior to first dose of study drug treatment until end of study.
• History of another malignancy in the previous 5 years, unless cured by surgery alone and continuously disease free. Exceptions include appropriately treated cervical carcinoma in situ, non-melanoma skin carcinoma, Stage I uterine cancer, localized prostate cancer that has been treated surgically and is presumed cured, or other malignancies with an expected curative outcome.
• Brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression without evidence of clinically stable disease for more than 14 days.
• Note: Patients with treated CNS metastases who are asymptomatic and on a stable dose of corticosteroids for more than 14 days prior to Cycle 1 Day 1 are eligible.
• For patients given cobimetinib: Evidence of visible retinal pathology that is considered a risk factor for neurosensory detachment, retinal vein occlusion, or neovascular macular degeneration, or of conditions that are risk factors for retinal vein occlusion.
• Current or history of clinically significant cardiac or pulmonary dysfunction.
• Lack of recovery to Grade 1 or better from adverse events due to investigational or other agents administered more than 28 days prior to enrollment, except for alopecia.
• Current severe, uncontrolled systemic disease.
• Inability or unwillingness to swallow pills.
• History of malabsorption or other condition that would interfere with gastrointestinal absorption of study drug.
• History of clinically significant liver disease, current alcohol abuse, or known infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV).
• Severe (Grade 3 and above) active infection at enrollment, or other serious underlying medical conditions.
• Required medication known to cause edema and/or cardiac failure.
• Active autoimmune disease.
• Uncontrolled ascites requiring weekly, large-volume paracentesis for 3 consecutive weeks prior to enrollment.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Sarasota, Florida, United States
• Study site — Detroit, Michigan, United States
• Study site — Canton, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.