Solid TumorPhase 1NCT01875705
A Dose-Escalation Study of GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing GDC-0994 in people with Solid Tumor, run by Genentech, Inc. at 4 sites in 2 countries.
Trial summary
This is an open-label, multicenter, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0994 in patients with locally advanced or metastatic solid tumors. Patients will be enrolled in one of two stages: a dose-escalation stage (Stage I) or the subsequent expansion stage (Stage II). 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?
- GDC-0994
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 21 Jun 2013to 23 Sep 2016
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically documented, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable
- Evaluable disease or disease measurable per RECIST 1.1
- Life expectancy >= 12 weeks
- Adequate hematologic and end organ function
- Consent to provide archival tissue
Who cannot join
- History of prior significant toxicity from another MEK or ERK inhibitor requiring discontinuation of treatment
- History of parathyroid disorder or history or malignancy-associated hypercalcemia requiring therapy in the past 6 months
- Evidence of visible retinal pathology as assessed by ophthalmologic examination that is considered a risk factor for retinal vein thrombosis or neurosensory retinal detachment
- History of glaucoma
- Intraocular pressure > 21 mmHg as measured by tonometry
- Predisposing factors to retinal vein occlusion, including uncontrolled hypertension, uncontrolled diabetes, uncontrolled hyperlipidemia, and coagulopathy
Show all 21Show fewer
- History of retinal vein occlusion (RVO), neurosensory retinal detachment, or neovascular macular degeneration
- Allergy or hypersensitivity to components of the GDC-0994 formulation
- Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in Cycle 1
- Experimental therapy within 4 weeks prior to first dose of study drug treatment in Cycle 1
- Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug treatment in Cycle 1, or anticipation of the need for major surgery during the course of study treatment
- Prior anti-cancer therapy within 28 days or 5 times the half-life whichever is longer
- Current severe, uncontrolled systemic disease
- History of clinically significant cardiac dysfunction
- Pregnancy, lactation, or breastfeeding
- Active autoimmune disease
- Inability or unwillingness to swallow pills
- Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
- 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 warfarin or thrombolytic anticoagulants
- Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Karmanos Can Inst
Detroit, Michigan, 48201
Sarah Cannon Research Inst.
Nashville, Tennessee, 37203
Yale Cancer Center; Medical Oncology
New Haven, Connecticut, 06520
France1 site
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif, 94805
About this study
Official title: An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors
This is an open-label, multicenter, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0994 in patients with locally advanced or metastatic solid tumors. Patients will be enrolled in one of two stages: a dose-escalation stage (Stage I) or the subsequent expansion stage (Stage II). Stage I will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0994 administered daily. Stage II will gather additional data on safety, tolerability, and pharmacokinetics of the recommended dose of GDC-0994 determined in Stage I.
- Conditions
- Solid Tumor
- Being tested
- GDC-0994
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-0994Drug
Escalating doses of GDC-0994 until maximum tolerated dose is reached
GDC-0994Drug
Recommended dose determined in Stage I-Dose Escalation phase, until disease progression
| Study group | Role | What they receive |
|---|---|---|
| Stage I-Dose Escalation | Experimental | Not described Receives: Drug: GDC-0994 |
| Stage II-Cohort-Expansion | Experimental | Not described Receives: Drug: GDC-0994 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of adverse events
Measured: Approximately 2 years
Maximum tolerated dose
Measured: Approximately 2 years
Dose-limiting toxicities
Measured: Approximately 2 years
Pharmacokinetics: Area under the concentration-time curve
Measured: Approximately 2 years
Pharmacokinetics: Maximum plasma concentrations
Measured: Approximately 2 years
Pharmacokinetics: Minimum plasma concentrations
Measured: Approximately 2 years
Pharmacokinetics: Time to maximum plasma concentration
Measured: Approximately 2 years
Pharmacokinetics: Apparent terminal elimination half-life
Measured: Approximately 2 years
Secondary outcomes (4)
To assess the PD effects of GDC-0994, as measured by changes in molecular biomarkers in pre- and post-treatment tumor tissues\n
Measured: Approximately 2 years
Objective Response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Measured: Approximately 2 years
Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Measured: Approximately 2 years
Duration of response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study start21 Jun 2013
- Primary completion23 Sep 2016
- Study completion23 Sep 2016
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT01875705
- Sponsor's protocol ID
- GO28885
- Other IDs
- 2013-000566-10
- Status last verified
- Apr 2018
- First submitted
- 10 Jun 2013
- Last updated
- 6 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT01875705
- Acronym / sponsor ID
- GO28885
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2013 (actual)
- Primary completion
- 23 Sep 2016 (actual)
- Study completion
- 23 Sep 2016 (actual)
- First posted
- 12 Jun 2013 (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 an open-label, multicenter, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0994 in patients with locally advanced or metastatic solid tumors. Patients will be enrolled in one of two stages: a dose-escalation stage (Stage I) or the subsequent expansion stage (Stage II). Stage I will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0994 administered daily. Stage II will gather additional data on safety, tolerability, and pharmacokinetics of the recommended dose of GDC-0994 determined in Stage I.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage I-Dose Escalation | Experimental | Drug: GDC-0994 |
| Stage II-Cohort-Expansion | Experimental | Drug: GDC-0994 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically documented, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable
- Evaluable disease or disease measurable per RECIST 1.1
- Life expectancy >= 12 weeks
- Adequate hematologic and end organ function
Key exclusion criteria (21 listed)
- History of prior significant toxicity from another MEK or ERK inhibitor requiring discontinuation of treatment
- History of parathyroid disorder or history or malignancy-associated hypercalcemia requiring therapy in the past 6 months
- Evidence of visible retinal pathology as assessed by ophthalmologic examination that is considered a risk factor for retinal vein thrombosis or neurosensory retinal detachment
- History of glaucoma
- Intraocular pressure > 21 mmHg as measured by tonometry
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-0994Escalating doses of GDC-0994 until maximum tolerated dose is reached | Drug | Stage I-Dose Escalation |
| GDC-0994Recommended dose determined in Stage I-Dose Escalation phase, until disease progression | Drug | Stage II-Cohort-Expansion |
Primary outcome
Safety: Incidence of adverse events
Time frame: Approximately 2 years
Maximum tolerated dose
Time frame: Approximately 2 years
Dose-limiting toxicities
Time frame: Approximately 2 years
Pharmacokinetics: Area under the concentration-time curve
Time frame: Approximately 2 years
Pharmacokinetics: Maximum plasma concentrations
Time frame: Approximately 2 years
Pharmacokinetics: Minimum plasma concentrations
Time frame: Approximately 2 years
Pharmacokinetics: Time to maximum plasma concentration
Time frame: Approximately 2 years
Pharmacokinetics: Apparent terminal elimination half-life
Time frame: Approximately 2 years
4 secondary outcomes
To assess the PD effects of GDC-0994, as measured by changes in molecular biomarkers in pre- and post-treatment tumor tissues\n
Time frame: Approximately 2 years
Objective Response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: Approximately 2 years
Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: Approximately 2 years
Duration of response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: Approximately 2 years
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 6 Apr 2018.
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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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GDC-0994 in people with Solid Tumor, run by Genentech, Inc. at 4 sites in 2 countries.
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 6 inclusion and 21 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 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, France. 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?
Safety: Incidence of adverse events (time frame: Approximately 2 years). The study lists 8 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 6 Apr 2018.