Solid CancersPhase 1NCT01075464
A Study of the Safety and Pharmacology of MEGF0444A in Combination With Bevacizumab With or Without Paclitaxel in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing MEGF0444A, bevacizumab and paclitaxel in people with Solid Cancers, run by Genentech, Inc. at 5 sites in United States.
Trial summary
This is a Phase Ib, open-label, dose-escalation study of MEGF0444A in combination with bevacizumab, and in combination with bevacizumab and paclitaxel as therapy for locally advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Cancers
- What is being tested?
- MEGF0444A, bevacizumab and paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2010to Apr 2013
- 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
- Histologically or cytologically documented, incurable, or metastatic solid malignancy that has progressed on or failed to respond to regimens or therapies known to provide clinical benefit
- Specific to Arm A:
- For patients undergoing optional or mandatory exploratory MRI, at least one tumor lesion that represents a liver, fixed peritoneal, neck, extremity, or pelvic lesion measuring >/= 3 to 10 cm (for liver lesions) or >= 2 to 10 cm (for all other lesion locations) to be used for MRI
- Specific to Arm B:
- Maximum of two prior chemotherapy regimens for metastatic disease
Who cannot join
- Anti-cancer therapy within 3 weeks prior to initiation of study treatment
- Patients who had to discontinue prior bevacizumab therapy due to intolerable toxicity
- Leptomeningeal disease
- Active infection or autoimmune disease
- Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis
- Known primary central nervous system (CNS) malignancy or untreated or active CNS metastases
Show all 14Show fewer
- Inadequately controlled hypertension; history of hypertensive crisis or encephalopathy; congestive heart failure (New York Heart Association Class II or greater); history of myocardial infarction or unstable angina within 6 months prior to initiation of study treatment
- History of hemoptysis; evidence of bleeding diathesis or significant coagulopathy
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to initiation of study treatment
- Serious, non-healing wound, active gastrointestinal ulcer, or untreated bone fracture
- Specific to Arm B:
- Known significant hypersensitivity to paclitaxel or other drugs using the vehicle cremophor
- Previous intolerance to paclitaxel
- Grade >= 2 sensory neuropathy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Nashville, Tennessee, 37203
Study site
San Francisco, California, 94115
Study site
Santa Monica, California, 90404
Study site
Scottsdale, Arizona, 85258
Study site
Tampa, Florida, 33612
About this study
Official title: A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MEGF0444A, a Human IgG1 Antibody, in Combination With Bevacizumab and Paclitaxel in Patients With Locally Advanced or Metastatic Solid Tumors
This is a Phase Ib, open-label, dose-escalation study of MEGF0444A in combination with bevacizumab, and in combination with bevacizumab and paclitaxel as therapy for locally advanced or metastatic solid tumors.
- Conditions
- Solid Cancers
- Being tested
- MEGF0444A, bevacizumab, paclitaxel
- Keywords
- Solid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEGF0444ADrug
Intravenous escalating dose
bevacizumabDrug
Intravenous repeating dose
paclitaxelDrug
Intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: MEGF0444A; Drug: bevacizumab |
| B | Experimental | Not described Receives: Drug: MEGF0444A; Drug: bevacizumab; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and nature of dose-limiting toxicities (DLTs)
Measured: Days 1 to 28 of Cycle 1
Incidence, nature, and severity of adverse events
Measured: Until 90 days after last dose of study treatment
Secondary outcomes (1)
Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution
Measured: Following administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid CancersStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075464
- Sponsor's protocol ID
- MEF4797g
- Other IDs
- GO01328
- Status last verified
- Nov 2016
- First submitted
- 24 Feb 2010
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MEGF0444A, a Human IgG1 Antibody, in Combination With Bevacizumab and Paclitaxel in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT01075464
- Acronym / sponsor ID
- MEF4797g
- Conditions
- Solid Cancers
- Keywords
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 25 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase Ib, open-label, dose-escalation study of MEGF0444A in combination with bevacizumab, and in combination with bevacizumab and paclitaxel as therapy for locally advanced or metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: MEGF0444A, Drug: bevacizumab |
| B | Experimental | Drug: MEGF0444A, Drug: bevacizumab, Drug: paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically documented, incurable, or metastatic solid malignancy that has progressed on or failed to respond to regimens or therapies known to provide clinical benefit
- For patients undergoing optional or mandatory exploratory MRI, at least one tumor lesion that represents a liver, fixed peritoneal, neck, extremity, or pelvic lesion measuring >/= 3 to 10 cm (for liver lesions) or >= 2 to 10 cm (for all other lesion locations) to be used for MRI
- Maximum of two prior chemotherapy regimens for metastatic disease
Key exclusion criteria (14 listed)
- Anti-cancer therapy within 3 weeks prior to initiation of study treatment
- Patients who had to discontinue prior bevacizumab therapy due to intolerable toxicity
- Leptomeningeal disease
- Active infection or autoimmune disease
- Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEGF0444AIntravenous escalating dose | Drug | A, B |
| bevacizumabIntravenous repeating dose | Drug | A, B |
| paclitaxelIntravenous repeating dose | Drug | B |
Primary outcome
Incidence and nature of dose-limiting toxicities (DLTs)
Time frame: Days 1 to 28 of Cycle 1
Incidence, nature, and severity of adverse events
Time frame: Until 90 days after last dose of study treatment
1 secondary outcome
Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution
Time frame: Following administration of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEGF0444A, bevacizumab and paclitaxel in people with Solid Cancers, run by Genentech, Inc. at 5 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 5 inclusion and 14 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: finished, 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 5 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence and nature of dose-limiting toxicities (DLTs) (time frame: Days 1 to 28 of Cycle 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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; AzTrials last refreshed its copy on 8 Nov 2026.