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History of Changes for Study: NCT01974258
Safety, Tolerability, and Pharmacokinetics of Onartuzumab Combined With Vemurafenib and/or Cobimetinib in Cancer Patients
Latest version (submitted November 1, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 28, 2013 None (earliest Version on record)
2 November 4, 2013 Study Status and Contacts/Locations
3 November 25, 2013 Recruitment Status, Contacts/Locations, Study Status and Oversight
4 December 3, 2013 Study Status and Contacts/Locations
5 December 9, 2013 Contacts/Locations and Study Status
6 January 6, 2014 Study Status
7 January 13, 2014 Contacts/Locations and Study Status
8 January 20, 2014 Study Status
9 January 27, 2014 Contacts/Locations and Study Status
10 February 3, 2014 Study Status and Contacts/Locations
11 February 10, 2014 Contacts/Locations and Study Status
12 February 24, 2014 Study Status and Contacts/Locations
13 March 3, 2014 Study Status
14 March 14, 2014 Contacts/Locations and Study Status
15 March 24, 2014 Study Status
16 April 7, 2014 Study Status
17 May 5, 2014 Study Status
18 June 23, 2014 Study Status, Contacts/Locations and Study Description
19 July 7, 2014 Study Status and Contacts/Locations
20 July 14, 2014 Study Status
21 July 21, 2014 Contacts/Locations and Study Status
22 October 3, 2014 Recruitment Status, Study Status, Contacts/Locations and Study Design
23 October 13, 2014 Study Status
24 November 3, 2014 Study Status
25 December 8, 2014 Study Status
26 December 23, 2014 Study Status
27 January 6, 2015 Study Status
28 January 19, 2015 Study Status
29 February 5, 2015 Study Status, Eligibility and Study Description
30 March 2, 2015 Study Status
31 May 5, 2015 Study Status
32 June 1, 2015 Study Status
33 July 1, 2015 Study Status
34 August 17, 2015 Study Status
35 September 1, 2015 Study Status
36 October 1, 2015 Study Status
37 November 2, 2015 Study Status
38 December 1, 2015 Study Status
39 February 1, 2016 Study Status
40 June 1, 2016 Study Status
41 July 1, 2016 Study Status
42 August 1, 2016 Recruitment Status, Study Status, Study Design and Oversight
43 September 1, 2016 Study Status
44 October 3, 2016 Study Status
45 November 1, 2016 Study Status
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Study NCT01974258
Submitted Date:  October 28, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: GO29026
Brief Title: Safety, Tolerability, and Pharmacokinetics of Onartuzumab Combined With Vemurafenib and/or Cobimetinib in Cancer Patients
Official Title: A PHASE Ib, OPEN-LABEL STUDY EVALUATING THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF ONARTUZUMAB IN COMBINATION WITH VEMURAFENIB AND/OR COBIMETINIB IN PATIENTS WITH ADVANCED SOLID MALIGNANCIES
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2013
Overall Status: Not yet recruiting
Study Start: November 2013
Primary Completion: May 2017 [Anticipated]
Study Completion: May 2017 [Anticipated]
First Submitted: October 28, 2013
First Submitted that
Met QC Criteria:
October 28, 2013
First Posted: November 1, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 28, 2013
Last Update Posted: November 1, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Hoffmann-La Roche
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: This study will evaluate the maximum tolerated dose and dose-limiting toxicities of vemurafenib and/or cobimetinib when used with onartuzumab in cancer patients.
Detailed Description:
Open or close this module Conditions
Conditions: Neoplasms
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 96 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Dose-finding: onartuzumab + vemurafenib + cobimetinib Drug: Vemurafenib
Orally administered twice daily
Drug: Onartuzumab
Administered by IV infusion every 2 weeks
Drug: Cobimetinib
Escalating dose
Experimental: Dose-expansion: onartuzumab + vemurafenib Drug: Vemurafenib
Orally administered twice daily
Drug: Onartuzumab
Administered by IV infusion every 2 weeks
Experimental: Dose-expansion: onartuzumab + cobimetinib Drug: Onartuzumab
Administered by IV infusion every 2 weeks
Drug: Cobimetinib
Orally administered once daily for 21 consecutive days, followed by 7 days off.
Experimental: Dose-expansion: onartuzumab + vemurafenib + cobimetinib Drug: Vemurafenib
Orally administered twice daily
Drug: Onartuzumab
Administered by IV infusion every 2 weeks
Drug: Cobimetinib
Orally administered once daily for 21 consecutive days, followed by 7 days off.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Safety: Incidence of dose-limiting toxicities (DLTs) of vermurafenib and/or cobimetinib used in combination with onartuzumab.
[ Time Frame: 24 to 36 months ]

2. Safety: Incidence of anti-therapeutic antibodies against onartuzumab.
[ Time Frame: 24 to 36 months ]

3. Safety: Incidence of adverse events (AE)
[ Time Frame: 24 to 36 months ]

Secondary Outcome Measures:
1. Pharmacokinetics: Maximum concentration (Cmax) of onartuzumab
[ Time Frame: 24 to 36 months ]

2. Pharmacokinetics: Maximum concentration (Cmax) of cobimetinib
[ Time Frame: 24 to 36 months ]

3. Pharmacokinetics: Maximum concentration (Cmax) of vemurafenib
[ Time Frame: 24 to 36 months ]

4. Efficacy: Overall response rate
[ Time Frame: 24 to 36 months ]

5. Efficacy: Progression-free survival
[ Time Frame: 24 to 36 months ]

6. Efficacy: Duration of response
[ Time Frame: 24 to 36 months ]

7. Efficacy: Overall survival
[ Time Frame: 24 to 36 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Open or close this module Contacts/Locations
Central Contact Person: Reference Study ID Number: GO29026 www.roche.com/about_roche/roche_worldwide.htm
Telephone: 888-662-6728 (U.S. Only)
Email: global.rochegenentechtrials@roche.com
Study Officials: Clinical Trials
Study Director
Hoffmann-La Roche
Locations: United States, Florida
Sarasota, Florida, United States, 34232
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Ohio
Canton, Ohio, United States, 44718
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Nashville, Tennessee, United States, 37203
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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