Metastatic Breast CancerPhase 1NCT00928330
Trastuzumab and Trastuzumab-MCC-DM1 Administered Intravenously and GDC-0941 Administered Orally to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed on Previous Trastuzumab-Based Therapy
A Phase 1 study testing GDC-0941, Trastuzumab and trastuzumab-MCC-DM1 in people with Metastatic Breast Cancer, run by Genentech, Inc. at 3 sites in United States.
Trial summary
This multicenter, Phase Ib study is an open label, dose escalation, three-arm study evaluating the safety, tolerability, pharmacokinetics, and activity of oral (PO) GDC 0941 administered in combination with either intravenous (IV) infusion of T-DM1 or IV infusion of trastuzumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- GDC-0941, Trastuzumab and trastuzumab-MCC-DM1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2009to Jan 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
- Histologically documented locally advanced or metastatic breast cancer that has progressed on at least one trastuzumab-based regimen in the metastatic or locally advanced setting
- HER2-positive disease documented by one of the following results using FDA-approved testing methods: FISH-positive, chromogenic in situ hybridization (CISH)-positive, or IHC 3 + by local laboratory assessment
- Life expectancy >= 90 days
- Agreement to use an effective form of contraception for the duration of the study
Who cannot join
- History of Grade >= 3 hypersensitivity reaction to trastuzumab, or Grade >= 1 with the most recent trastuzumab infusion before study entry, or continued requirement for prolonged trastuzumab infusions to prevent hypersensitivity reactions
- History of intolerance to trastuzumab and/or adverse events related to trastuzumab that resulted in trastuzumab being permanently discontinued
- Prior anti-cancer therapy (e.g., biologic or other targeted therapy, chemotherapy, hormonal therapy) within 2 weeks prior to Day 1
- Prior investigational anti-cancer therapy within 4 weeks prior to Day 1
- Grade >= 2 peripheral neuropathy
- History of Grade >= 3 hyperglycemia (fasting)
Show all 18Show fewer
- History of Type 1 or Type 2 diabetes requiring daily medication
- History of clinically significant cardiac or pulmonary dysfunction
- History of malabsorption syndrome or other condition that would interfere with enteral absorption
- Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with HIV, hepatitis B virus, or hepatitis C virus
- Any condition requiring anticoagulants, such as warfarin, heparin, or thrombolytic agents
- Any condition requiring > 2 grams of acetaminophen daily
- Need for current chronic corticosteroid therapy
- Pregnancy, lactation, or breast-feeding
- Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
- Major surgical procedure or significant traumatic injury within 28 days prior to Day 1, or anticipation of the need for major surgery during the course of study treatment
- Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
- Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Baltimore, Maryland, 21231
Study site
Boston, Massachusetts, 02115
Study site
Indianapolis, Indiana, 46202
About this study
Official title: A Phase Ib, Open-Label Study of the Safety, Tolerability, Pharmacokinetics, and Activity of Trastuzumab and Trastuzumab-MCC-DM1 Administered Intravenously and GDC-0941 Administered Orally to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed on Previous Trastuzumab-Based Therapy
This multicenter, Phase Ib study is an open label, dose escalation, three-arm study evaluating the safety, tolerability, pharmacokinetics, and activity of oral (PO) GDC 0941 administered in combination with either intravenous (IV) infusion of T-DM1 or IV infusion of trastuzumab.
- Conditions
- Metastatic Breast Cancer
- Being tested
- GDC-0941, Trastuzumab, trastuzumab-MCC-DM1
- Keywords
- TDM-1, HER2, HER2+, HER2+ Breast Cancer, HER-2, MBC, Trastuzumab emtansine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-0941Drug
Oral repeating dose
TrastuzumabDrug
Intravenous repeating dose
trastuzumab-MCC-DM1Drug
Intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: GDC-0941; Drug: trastuzumab-MCC-DM1 |
| B | Experimental | Not described Receives: Drug: GDC-0941; Drug: trastuzumab-MCC-DM1 |
| C | Experimental | Not described Receives: Drug: GDC-0941; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cardiac function
Measured: Through study completion or early study discontinuation
Changes in vital signs, physical findings, and clinical laboratory results during and following administration of study drugs that result in dose modification, dose delay, or discontinuation of T-DM1 and/or GDC 0941
Measured: Through study completion or early study discontinuation
Incidence, nature, and severity of adverse events
Measured: Through study completion or early study discontinuation
Secondary outcomes (4)
PK parameters of T-DM1 and GDC-0941 (total exposure, maximum serum concentration, and minimum concentration)
Measured: Through study completion or early study discontinuation
Progression-free survival (PFS)
Measured: From study treatment initiation to the first occurrence of disease progression or death on study
Objective response based on investigator assessment
Measured: Confirmed response >/= 4 weeks after initial documentation of response
Duration of response
Measured: Time from initial complete or partial response to the time of disease progression or death on study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 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
- NCT00928330
- Sponsor's protocol ID
- GDC4627g
- Other IDs
- GO01302
- Status last verified
- Nov 2016
- First submitted
- 23 Jun 2009
- 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 Study of the Safety, Tolerability, Pharmacokinetics, and Activity of Trastuzumab and Trastuzumab-MCC-DM1 Administered Intravenously and GDC-0941 Administered Orally to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed on Previous Trastuzumab-Based Therapy
- ClinicalTrials.gov ID
- NCT00928330
- Acronym / sponsor ID
- GDC4627g
- Conditions
- Metastatic Breast Cancer
- Keywords
- TDM-1, HER2, HER2+, HER2+ Breast Cancer, HER-2, MBC, Trastuzumab emtansine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 25 Jun 2009 (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 multicenter, Phase Ib study is an open label, dose escalation, three-arm study evaluating the safety, tolerability, pharmacokinetics, and activity of oral (PO) GDC 0941 administered in combination with either intravenous (IV) infusion of T-DM1 or IV infusion of trastuzumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: GDC-0941, Drug: trastuzumab-MCC-DM1 |
| B | Experimental | Drug: GDC-0941, Drug: trastuzumab-MCC-DM1 |
| C | Experimental | Drug: GDC-0941, Drug: Trastuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically documented locally advanced or metastatic breast cancer that has progressed on at least one trastuzumab-based regimen in the metastatic or locally advanced setting
- HER2-positive disease documented by one of the following results using FDA-approved testing methods: FISH-positive, chromogenic in situ hybridization (CISH)-positive, or IHC 3 + by local laboratory assessment
- Life expectancy >= 90 days
- Agreement to use an effective form of contraception for the duration of the study
Key exclusion criteria (18 listed)
- History of Grade >= 3 hypersensitivity reaction to trastuzumab, or Grade >= 1 with the most recent trastuzumab infusion before study entry, or continued requirement for prolonged trastuzumab infusions to prevent hypersensitivity reactions
- History of intolerance to trastuzumab and/or adverse events related to trastuzumab that resulted in trastuzumab being permanently discontinued
- Prior anti-cancer therapy (e.g., biologic or other targeted therapy, chemotherapy, hormonal therapy) within 2 weeks prior to Day 1
- Prior investigational anti-cancer therapy within 4 weeks prior to Day 1
- Grade >= 2 peripheral neuropathy
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 |
|---|---|---|
| GDC-0941Oral repeating dose | Drug | A, B, C |
| TrastuzumabIntravenous repeating dose | Drug | C |
| trastuzumab-MCC-DM1Intravenous repeating dose | Drug | A, B |
Primary outcome
Changes in cardiac function
Time frame: Through study completion or early study discontinuation
Changes in vital signs, physical findings, and clinical laboratory results during and following administration of study drugs that result in dose modification, dose delay, or discontinuation of T-DM1 and/or GDC 0941
Time frame: Through study completion or early study discontinuation
Incidence, nature, and severity of adverse events
Time frame: Through study completion or early study discontinuation
4 secondary outcomes
PK parameters of T-DM1 and GDC-0941 (total exposure, maximum serum concentration, and minimum concentration)
Time frame: Through study completion or early study discontinuation
Progression-free survival (PFS)
Time frame: From study treatment initiation to the first occurrence of disease progression or death on study
Objective response based on investigator assessment
Time frame: Confirmed response >/= 4 weeks after initial documentation of response
Duration of response
Time frame: Time from initial complete or partial response to the time of disease progression or death on study
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.
3 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 GDC-0941, Trastuzumab and trastuzumab-MCC-DM1 in people with Metastatic Breast Cancer, run by Genentech, Inc. at 3 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 4 inclusion and 18 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 3 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?
Changes in cardiac function (time frame: Through study completion or early study discontinuation). 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?
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.