Non-Small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic Cancers, MelanomaPhase 1NCT02457793

A Study of the Safety, Tolerability, and Effects of Cobimetinib and GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors

A Phase 1 study testing Cobimetinib and GDC-0994 in people with Non-Small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic Cancers, Melanoma, run by Genentech, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a two-stage dose-escalation study to assess the safety, tolerability and effects of oral dosing of cobimetinib and GDC-0994 administered in combination in patients with histologically confirmed, locally advanced, or metastatic solid tumors for which standard therapies either do not exist or have proven… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic Cancers, Melanoma
What is being tested?: Cobimetinib and GDC-0994
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 5 sitesUnited States
Study dates: 16 Jun 2015to 5 Dec 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Life expectancy > or = 12 weeks
Adequate hematologic and end organ function
For female patients of childbearing potential and male patients with partners of childbearing potential, use of an effective form of contraception with continued use for study duration and up to 3 months or more following discontinuation of treatment drug

Show all 10Show fewer

Fluorodeoxyglucose positron emission tomography (FDG-PET) avid disease on baseline scan
For enrollment in part 2, patients must meet all of the following:
Measurable disease
No more than four prior systemic therapies for locally advanced or metastatic cancer

Who cannot join

History of prior significant toxicity from another MEK inhibitor or ERK inhibitor requiring discontinuation of treatment
Evidence of visible retinal pathology as assessed by ophthalmologic examination that is considered a risk factor for retinal vein thrombosis
History of glaucoma
Intraocular pressure > 21 mmHg as measured by tonometry
Predisposing factors to retinal vein occlusion (RVO)
History of RVO, neurosensory retinal detachment, or neovascular macular degeneration

Show all 25Show fewer

Allergy or hypersensitivity to components of the cobimetinib or 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 the first dose of study-drug treatment in Cycle 1, or anticipation of the need for major surgery during the course of study treatment
Anti-cancer therapy within 28 days prior to the first dose of study-drug treatment in Cycle 1
Current severe, uncontrolled systemic disease
History of clinically significant cardiac dysfunction
History of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment
History of myocardial infarction within 6 months prior to the first dose of study-drug treatment in Cycle 1
History of congenital long QT syndrome or QTc > 470 msec
LVEF
History of malabsorption or other condition that would interfere with enteral absorption
Clinically significant history of liver disease, current alcohol abuse, or current known active infection with HIV, hepatitis B virus, or hepatitis C virus
Any condition requiring warfarin or thrombolytic anticoagulants
Active autoimmune disease
Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment
Pregnancy, lactation, or breastfeeding
Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
No other history of or ongoing malignancy that would potentially interfere with the interpretation of the Pharmacodynamic (PD) or efficacy assays

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

University of Colorado
Aurora, Colorado, 80045-2517
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Yale Cancer Center
New Haven, Connecticut, 06520
Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase Ib, Open-Label, Dose-Escalation Study Of The Safety, Tolerability, and Pharmacokinetics of Cobimetinib and GDC-0994 In Patients With Locally Advanced or Metastatic Solid Tumors

Conditions: Non-Small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic Cancers, Melanoma
Being tested: Cobimetinib, GDC-0994
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Neoplasms, Melanoma

What participants receive

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

CobimetinibDrug
Cobimetinib given concurrently or intermittently with GDC-0994 for 21 consecutive days followed by 7 days off.
GDC-0994Drug
GDC-0994 given for 21 consecutive days followed by 7 days off, along with concurrent or intermittent dosing of cobimetinib.

Study groups in NCT02457793
Study group	Role	What they receive
Not assigned	Experimental	One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration. Receives: Drug: Cobimetinib; Drug: GDC-0994
COB 20 mg + GDC 200 mg	Experimental	Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. Receives: Drug: Cobimetinib; Drug: GDC-0994
COB 40 mg + GDC 200 mg	Experimental	Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. Receives: Drug: Cobimetinib; Drug: GDC-0994
COB 80 mg + GDC 200 mg	Experimental	Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. Receives: Drug: Cobimetinib; Drug: GDC-0994
COB 80 mg + GDC 400 mg	Experimental	Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off. Receives: Drug: Cobimetinib; Drug: GDC-0994
COB 100 mg + GDC 200 mg	Experimental	Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. Receives: Drug: Cobimetinib; Drug: GDC-0994

What is being measured

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

Number of Participants With Dose-Limiting Toxicities (DLTs)
DLTs include symptoms considered by the investigator to be possibly related to study drug.
Measured: 28 days (Cycle 1)
Percentage of Participants With at Least One Adverse Event
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
Measured: Up to 15 months
Percentage of Participants With at Least One Adverse Event of Special Interest
AESIs were graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0. AESIs included the following: Grade ≥ 1 retinal vein occlusion; Grade ≥ 2 visual disturbances (including events suggestive of serous retinopathy); Grade ≥ 3 rash for > 7 days; Grade ≥ 3 diarrhea for > 3 days; Grade ≥ 2 left ventricular ejection fraction (LVEF) decrease; Grade 3 hepatotoxicity; any dose-limiting toxicity (DLT); cases of potential drug-induced liver injury that include an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (AST > 3 × baseline value [and above the upper limit of normal, ULN]) in combination with either an elevated bilirubin ( > 2 × ULN) or clinical jaundice; or suspected transmission of an infectious agent by either study drug.
Measured: Up to 15 months
Percentage of Participants With at Least One Serious Adverse Event (SAE)
A SAE is any experience that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant.
Measured: Up to 15 months
Percentage of Participants With Laboratory Abnormalities
Laboratory abnormalities were graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0.
SGPT/ALT - serum glutamic-pyruvic transaminase/alanine aminotransferase; SGOT/AST - serum glutamic oxaloacetic transaminase/aspartate aminotransferase
Measured: Up to 15 months
Mean Change From Baseline in Diastolic Blood Pressure
Measured: Baseline, up to 15 months
Mean Change From Baseline in Lean Body Mass
Measured: Baseline, Day 15
Mean Change From Baseline in Pulse Rate
Measured: Baseline, up to 15 months
Mean Change From Baseline in Respiratory Rate
Measured: Baseline, up to 15 months
Mean Change From Baseline in Systolic Blood Pressure
Measured: Baseline, up to 15 months
Mean Change From Baseline in Temperature
Measured: Baseline, up to 15 months
Mean Change From Baseline in Weight
Measured: Baseline, up to 15 months

Secondary outcomes (10)

Maximum Serum Concentration (Cmax) for GDC-0994
Measured: Up to Day 22
Median Time to Maximum Serum Concentration (Tmax) for GDC-0994
Measured: Up to Day 22
Maximum Serum Concentration (Cmax) for Cobimetinib
Measured: Up to Day 22
Median Time to Maximum Serum Concentration (Tmax) for Cobimetinib
Measured: Up to Day 22
Total Exposure (AUC From Time 0 to 24 Hour After Dose) for GDC-0994
Data are reported for evaluable participants.
Measured: 0 to 24 hours post-dose (Up to Day 22)
Total Exposure (AUC From Time 0 to 24 Hour After Dose) for Cobimetinib
Measured: 0 to 24 hours post-dose (Up to Day 22)
Mean Accumulation Ratio
Measured: Pre-dose Day 1 Cycle 1, 2, 3, Day 18, 21 Cycle 1; post-dose 0.5, 1, 2, 3, 4, 6 hours Day 1, 18, 21 Cycle 1; Day 2, 15, 19, 22, Cycle 1
Mean Terminal Half-life (t1/2)
Measured: Up to day 22 of study
Change From Baseline in Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)
Measured: Baseline, Day 15
Change From Baseline in Tumor Tissue Biomarkers
Measured: Up to 15 months

Timeline

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

16 Jun 20155 Dec 2016

First posted29 May 2015 (estimated)
Study start16 Jun 2015
Primary completion5 Dec 2016
Study completion5 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-Small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic Cancers, MelanomaStudies 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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02457793
Sponsor's protocol ID: GO29653
Other IDs: 2015-000092-27, 2015
Status last verified: Nov 2018
First submitted: 27 May 2015
Last updated: 20 Nov 2018
Results posted: Yes, on ClinicalTrials.gov

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2018. 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, Tolerability, and Pharmacokinetics of Cobimetinib and GDC-0994 In Patients With Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT02457793
Acronym / sponsor ID: GO29653
Conditions: Non-Small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic Cancers, Melanoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Genentech, Inc.Industry (pharma, biotech, devices)
Study start: 16 Jun 2015 (actual)
Primary completion: 5 Dec 2016 (actual)
Study completion: 5 Dec 2016 (actual)
First posted: 29 May 2015 (estimated)
Results: Posted 24 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Not assigned	Experimental	Drug: Cobimetinib, Drug: GDC-0994One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
COB 20 mg + GDC 200 mg	Experimental	Drug: Cobimetinib, Drug: GDC-0994Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
COB 40 mg + GDC 200 mg	Experimental	Drug: Cobimetinib, Drug: GDC-0994Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
COB 80 mg + GDC 200 mg	Experimental	Drug: Cobimetinib, Drug: GDC-0994Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
COB 80 mg + GDC 400 mg	Experimental	Drug: Cobimetinib, Drug: GDC-0994Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
COB 100 mg + GDC 200 mg	Experimental	Drug: Cobimetinib, Drug: GDC-0994Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 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
Life expectancy > or = 12 weeks
Adequate hematologic and end organ function

Key exclusion criteria (25 listed)

History of prior significant toxicity from another MEK inhibitor or ERK inhibitor requiring discontinuation of treatment
Evidence of visible retinal pathology as assessed by ophthalmologic examination that is considered a risk factor for retinal vein thrombosis
History of glaucoma
Intraocular pressure > 21 mmHg as measured by tonometry
Predisposing factors to retinal vein occlusion (RVO)

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
CobimetinibCobimetinib given concurrently or intermittently with GDC-0994 for 21 consecutive days followed by 7 days off.	Drug	COB 100 mg + GDC 200 mg, COB 20 mg + GDC 200 mg, COB 40 mg + GDC 200 mg, COB 80 mg + GDC 200 mg, COB 80 mg + GDC 400 mg, Not assigned
GDC-0994GDC-0994 given for 21 consecutive days followed by 7 days off, along with concurrent or intermittent dosing of cobimetinib.	Drug	COB 100 mg + GDC 200 mg, COB 20 mg + GDC 200 mg, COB 40 mg + GDC 200 mg, COB 80 mg + GDC 200 mg, COB 80 mg + GDC 400 mg, Not assigned

Primary outcome

Number of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: 28 days (Cycle 1)
DLTs include symptoms considered by the investigator to be possibly related to study drug.
Percentage of Participants With at Least One Adverse Event
Time frame: Up to 15 months
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
Percentage of Participants With at Least One Adverse Event of Special Interest
Time frame: Up to 15 months
AESIs were graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0. AESIs included the following: Grade ≥ 1 retinal vein occlusion; Grade ≥ 2 visual disturbances (including events suggestive of serous retinopathy); Grade ≥ 3 rash for > 7 days; Grade ≥ 3 diarrhea for > 3 days; Grade ≥ 2 left ventricular ejection fraction (LVEF) decrease; Grade 3 hepatotoxicity; any dose-limiting toxicity (DLT); cases of potential drug-induced liver injury that include an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (AST > 3 × baseline value [and above the upper limit of normal, ULN]) in combination with either an elevated bilirubin ( > 2 × ULN) or clinical jaundice; or suspected transmission of an infectious agent by either study drug.
Percentage of Participants With at Least One Serious Adverse Event (SAE)
Time frame: Up to 15 months
A SAE is any experience that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant.
Percentage of Participants With Laboratory Abnormalities
Time frame: Up to 15 months
Laboratory abnormalities were graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0. SGPT/ALT - serum glutamic-pyruvic transaminase/alanine aminotransferase; SGOT/AST - serum glutamic oxaloacetic transaminase/aspartate aminotransferase
Mean Change From Baseline in Diastolic Blood Pressure
Time frame: Baseline, up to 15 months
Mean Change From Baseline in Lean Body Mass
Time frame: Baseline, Day 15
Mean Change From Baseline in Pulse Rate
Time frame: Baseline, up to 15 months
Mean Change From Baseline in Respiratory Rate
Time frame: Baseline, up to 15 months
Mean Change From Baseline in Systolic Blood Pressure
Time frame: Baseline, up to 15 months
Mean Change From Baseline in Temperature
Time frame: Baseline, up to 15 months
Mean Change From Baseline in Weight
Time frame: Baseline, up to 15 months

10 secondary outcomes

Maximum Serum Concentration (Cmax) for GDC-0994
Time frame: Up to Day 22
Median Time to Maximum Serum Concentration (Tmax) for GDC-0994
Time frame: Up to Day 22
Maximum Serum Concentration (Cmax) for Cobimetinib
Time frame: Up to Day 22
Median Time to Maximum Serum Concentration (Tmax) for Cobimetinib
Time frame: Up to Day 22
Total Exposure (AUC From Time 0 to 24 Hour After Dose) for GDC-0994
Time frame: 0 to 24 hours post-dose (Up to Day 22)
Total Exposure (AUC From Time 0 to 24 Hour After Dose) for Cobimetinib
Time frame: 0 to 24 hours post-dose (Up to Day 22)
Mean Accumulation Ratio
Time frame: Pre-dose Day 1 Cycle 1, 2, 3, Day 18, 21 Cycle 1; post-dose 0.5, 1, 2, 3, 4, 6 hours Day 1, 18, 21 Cycle 1; Day 2, 15, 19, 22, Cycle 1
Mean Terminal Half-life (t1/2)
Time frame: Up to day 22 of study
Change From Baseline in Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)
Time frame: Baseline, Day 15
Change From Baseline in Tumor Tissue Biomarkers
Time frame: Up to 15 months

Results and safety

Results posted to the registry on 24 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Not Assigned	1	0
COB 20 mg + GDC 200 mg	5	1
COB 40 mg + GDC 200 mg	3	0
COB 80 mg + GDC 200 mg	5	0
COB 80 mg + GDC 400 mg	4	0
COB 100 mg + GDC 200 mg	6	0

Primary outcome: Number of Participants With Dose-Limiting Toxicities (DLTs)

Time frame: 28 days (Cycle 1). Count of participants. Unit: Participants

Measure	Not Assigned n = 1	COB 40 mg + GDC 200 mg n = 3	COB 80 mg + GDC 200 mg n = 5
Dermatitis Acneiform	1	0	0
Rash	1	0	0
Diarrhoea	0	1	0
Myocardial infarction	0	0	1

Population analysed: All participants.

Primary outcome: Percentage of Participants With at Least One Adverse Event

Time frame: Up to 15 months. Number. Unit: percentage of participants

Measure	Not Assigned n = 1	COB 20 mg + GDC 200 mg n = 5	COB 40 mg + GDC 200 mg n = 3	COB 80 mg + GDC 200 mg n = 5	COB 80 mg + GDC 400 mg n = 4	COB 100 mg + GDC 200 mg n = 6
Value	100	100	100	100	100	100

Population analysed: All participants.

Primary outcome: Percentage of Participants With at Least One Adverse Event of Special Interest

Time frame: Up to 15 months. Number. Unit: percentage of participants

Measure	Not Assigned n = 1	COB 20 mg + GDC 200 mg n = 5	COB 40 mg + GDC 200 mg n = 3	COB 80 mg + GDC 200 mg n = 5	COB 80 mg + GDC 400 mg n = 4	COB 100 mg + GDC 200 mg n = 6
Value	100.0	100	33.3	60.0	75.0	50.0

Population analysed: All participants.

Primary outcome: Percentage of Participants With at Least One Serious Adverse Event (SAE)

Time frame: Up to 15 months. Number. Unit: percentage of participants

Measure	Not Assigned n = 1	COB 20 mg + GDC 200 mg n = 5	COB 40 mg + GDC 200 mg n = 3	COB 80 mg + GDC 200 mg n = 5	COB 80 mg + GDC 400 mg n = 4	COB 100 mg + GDC 200 mg n = 6
Value	100.0	40.0	66.7	60.0	50.0	66.7

Population analysed: All participants.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 15 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Not Assigned	1 of 1 (100%)	1 of 1 (100%)	Not reported
COB 20 mg + GDC 200 mg	2 of 5 (40%)	5 of 5 (100%)	Not reported
COB 40 mg + GDC 200 mg	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
COB 80 mg + GDC 200 mg	3 of 5 (60%)	5 of 5 (100%)	Not reported
COB 80 mg + GDC 400 mg	2 of 4 (50%)	4 of 4 (100%)	Not reported
COB 100 mg + GDC 200 mg	4 of 6 (66.7%)	6 of 6 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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?

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 10 inclusion and 25 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 20 Nov 2018. 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?

Yes. Results are posted in the registry (first posted 24 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Dose-Limiting Toxicities (DLTs) (time frame: 28 days (Cycle 1)). The study lists 12 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 NCT02457793.

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 20 Nov 2018.