Solid TumorPhase 1NCT01363024
Trial Evaluating the Safety and Pharmacokinetics of MFGR1877S in Patients With Advanced Solid Tumors
A Phase 1 study testing MFGR1877S in people with Solid Tumor, run by Genentech, Inc. at 5 sites in United States.
Trial summary
This is a multicenter, open-label, dose-escalation study to assess the safety, tolerability and Pharmacokinetics of MGFR1877S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- MFGR1877S
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2011to Mar 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
- Life expectancy >/= 12 weeks
- ECOG performance status of 0 or 1
- Histologic or cytologic documentation of locally advanced, or metastatic solid malignancy that has relapsed after or failed to respond to at least one prior regimen or for which there is no standard therapy
- Evaluable or measurable disease. Prostate cancer patients with non-measurable disease are eligible if they have two rising prostate-specific antigen (PSA) levels (5 ng/mL measured 2 weeks apart) that meet the PSA Working Group criteria for progression prior to initiation of study treatment. Ovarian cancer patients with non-measurable disease are eligible if they have two rising CA-125 levels greater than the ULN (2 weeks apart prior to initiation of study treatment).
- Adequate hematologic and end organ function
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use an effective form of contraception and to continue its use until 90 days after the last dose of study treatment
- Consent to provide archival tissue
Who cannot join
- Prior use of any monoclonal antibody within 4 weeks before Cycle 1, Day 1
- Experimental therapy within 4 weeks prior to Cycle 1, Day 1
- Palliative radiotherapy within 2 weeks prior to Cycle 1, Day 1
- Prior anti-cancer therapy within 4 weeks prior to Cycle 1, Day 1
- Major surgical procedure or trauma within 4 weeks prior to Cycle 1, Day 1. All wounds must be fully healed on Cycle 1, Day 1.
- Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or pulmonary disease
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- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at screening or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1, Day 1
- History of other malignancy which could affect compliance with the protocol or interpretation of results. Patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are allowed. Patients with a malignancy that has been treated with curative intent will also be allowed if the malignancy has been in remission without treatment for >/= years prior to Cycle 1, Day 1.
- Presence of positive test results for Hepatitis B (Hepatitis B surface antigen [HBsAg] and/or total HB core antibody [anti-HB-c]) or Hepatitis C (Hepatitis C virus [HCV] antibody serology testing). Patients positive for anti-HB-c are eligible only if PCR is negative for HBV DNA.
- Known history of HIV seropositive status
- Primary CNS malignancy, or untreated/active CNS metastases
- Pregnancy, lactation or breastfeeding
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Aurora, Colorado, 80045
Study site
Chicago, Illinois, 60637
Study site
Nashville, Tennessee, 37203
Study site
Santa Monica, California, 90404
Study site
Scottsdale, Arizona, 85258
About this study
Official title: An Open-Label, Multicenter, Phase I Dose-Escalation Trial Evaluating the Safety and Pharmacokinetics of MFGR1877S in Patients With Advanced Solid Tumors
This is a multicenter, open-label, dose-escalation study to assess the safety, tolerability and Pharmacokinetics of MGFR1877S.
- Conditions
- Solid Tumor
- Being tested
- MFGR1877S
- Keywords
- Solid Cancers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MFGR1877SDrug
Intravenous escalating dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: MFGR1877S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose dose limiting toxicities (DLTs) by NCI CTCAE, v4.0
Measured: Days 1-28 of Cycle 1
Nature of dose limiting toxicities (DLTs) by NCI CTCAE, v4.0
Measured: Days 1-28 of Cycle 1
Secondary outcomes (3)
Incidence of adverse events by NCI CTCAE, v4.0
Measured: Up to 1 year
Nature of adverse events by NCI CTCAE, v4.0
Measured: Up to 1 year
Severity of adverse events by NCI CTCAE, v4.0
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isabelle A. Rooney, M.B., Ch.B., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363024
- Sponsor's protocol ID
- MFG4991g
- Other IDs
- GO27817
- Status last verified
- Nov 2016
- First submitted
- 27 May 2011
- 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
- An Open-Label, Multicenter, Phase I Dose-Escalation Trial Evaluating the Safety and Pharmacokinetics of MFGR1877S in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01363024
- Acronym / sponsor ID
- MFG4991g
- Conditions
- Solid Tumor
- Keywords
- Solid Cancers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 1 Jun 2011 (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 multicenter, open-label, dose-escalation study to assess the safety, tolerability and Pharmacokinetics of MGFR1877S.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: MFGR1877S |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Life expectancy >/= 12 weeks
- ECOG performance status of 0 or 1
- Histologic or cytologic documentation of locally advanced, or metastatic solid malignancy that has relapsed after or failed to respond to at least one prior regimen or for which there is no standard therapy
- Evaluable or measurable disease. Prostate cancer patients with non-measurable disease are eligible if they have two rising prostate-specific antigen (PSA) levels (5 ng/mL measured 2 weeks apart) that meet the PSA Working Group criteria for progression prior to initiation of study treatment. Ovarian cancer patients with non-measurable disease are eligible if they have two rising CA-125 levels greater than the ULN (2 weeks apart prior to initiation of study treatment).
- Adequate hematologic and end organ function
Key exclusion criteria (13 listed)
- Prior use of any monoclonal antibody within 4 weeks before Cycle 1, Day 1
- Experimental therapy within 4 weeks prior to Cycle 1, Day 1
- Palliative radiotherapy within 2 weeks prior to Cycle 1, Day 1
- Prior anti-cancer therapy within 4 weeks prior to Cycle 1, Day 1
- Major surgical procedure or trauma within 4 weeks prior to Cycle 1, Day 1. All wounds must be fully healed on Cycle 1, Day 1.
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 |
|---|---|---|
| MFGR1877SIntravenous escalating dose | Drug | A |
Primary outcome
Incidence of dose dose limiting toxicities (DLTs) by NCI CTCAE, v4.0
Time frame: Days 1-28 of Cycle 1
Nature of dose limiting toxicities (DLTs) by NCI CTCAE, v4.0
Time frame: Days 1-28 of Cycle 1
3 secondary outcomes
Incidence of adverse events by NCI CTCAE, v4.0
Time frame: Up to 1 year
Nature of adverse events by NCI CTCAE, v4.0
Time frame: Up to 1 year
Severity of adverse events by NCI CTCAE, v4.0
Time frame: Up to 1 year
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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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
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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.
Isabelle A. Rooney, M.B., Ch.B. 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 MFGR1877S in people with Solid Tumor, 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 7 inclusion and 13 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 of dose dose limiting toxicities (DLTs) by NCI CTCAE, v4.0 (time frame: Days 1-28 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.