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NeoplasmsPhase 1NCT01974258

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

A Phase 1 study testing Cobimetinib, Onartuzumab and Vemurafenib in people with Neoplasms, run by Hoffmann-La Roche at 6 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
Cobimetinib, Onartuzumab and Vemurafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
6 sitesUnited States
Study dates
Feb 2014to Jul 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Study site

    Canton, Ohio, 44718

  • Study site

    Detroit, Michigan, 48201

  • Study site

    Los Angeles, California, 90025

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    Oklahoma City, Oklahoma, 73104

  • Study site

    Sarasota, Florida, 34232

Other trials in United States

About this study

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

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

Conditions
Neoplasms
Being tested
Cobimetinib, Onartuzumab, Vemurafenib
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CobimetinibDrug

    Escalating dose

  • CobimetinibDrug

    Orally administered once daily for 21 consecutive days, followed by 7 days off.

  • OnartuzumabDrug

    Administered by IV infusion every 2 weeks

  • VemurafenibDrug

    Orally administered twice daily

Study groups in NCT01974258
Study groupRoleWhat they receive
Dose-expansion: onartuzumab + cobimetinibExperimentalNot described
Receives: Drug: Cobimetinib; Drug: Onartuzumab
Dose-expansion: onartuzumab + vemurafenibExperimentalNot described
Receives: Drug: Onartuzumab; Drug: Vemurafenib
Dose-expansion: onartuzumab + vemurafenib + cobimetinibExperimentalNot described
Receives: Drug: Cobimetinib; Drug: Onartuzumab; Drug: Vemurafenib
Dose-finding: onartuzumab + vemurafenib + cobimetinibExperimentalNot described
Receives: Drug: Cobimetinib; Drug: Onartuzumab; Drug: Vemurafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety: Incidence of dose-limiting toxicities (DLTs) of vermurafenib and/or cobimetinib used in combination with onartuzumab.

    Measured: 24 to 36 months

  2. Safety: Incidence of anti-therapeutic antibodies against onartuzumab.

    Measured: 24 to 36 months

  3. Safety: Incidence of adverse events (AE)

    Measured: 24 to 36 months

Secondary outcomes (7)

  1. Pharmacokinetics: Maximum concentration (Cmax) of onartuzumab

    Measured: 24 to 36 months

  2. Pharmacokinetics: Maximum concentration (Cmax) of cobimetinib

    Measured: 24 to 36 months

  3. Pharmacokinetics: Maximum concentration (Cmax) of vemurafenib

    Measured: 24 to 36 months

  4. Efficacy: Overall response rate

    Measured: 24 to 36 months

  5. Efficacy: Progression-free survival

    Measured: 24 to 36 months

  6. Efficacy: Duration of response

    Measured: 24 to 36 months

  7. Efficacy: Overall survival

    Measured: 24 to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2013 (estimated)
  2. Study startFeb 2014
  3. Primary completionJul 2014 (estimated)
  4. Study completionJul 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01974258
Sponsor's protocol ID
GO29026
Status last verified
Nov 2016
First submitted
28 Oct 2013
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cobimetinib, Onartuzumab and Vemurafenib in people with Neoplasms, run by Hoffmann-La Roche at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: Incidence of dose-limiting toxicities (DLTs) of vermurafenib and/or cobimetinib used in combination with onartuzumab. (time frame: 24 to 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01974258.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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