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Advanced Non-small Cell Lung CancerPhase 1NCT03681483

RO5126766 for Patients With Advanced KRAS-Mutant Lung Cancer

A Phase 1 study testing RO5126766 in people with Advanced Non-small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.

Completed

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

Official record
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Trial summary

The purpose of this study is to test the safety of RO5126766 at different doses to find out what effects, if any, it has on people with advanced lung cancer who have previously received treatment with a PD-1 or PD-L1 inhibitor. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Non-small Cell Lung Cancer
What is being tested?
RO5126766
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
3 sitesUnited States
Study dates
31 Oct 2018to 8 Jul 2024
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 proven diagnosis of advanced NSCLC
  • Documented presence of KRAS mutation
  • Prior treatment with a PD-1/L1 inhibitor. Patients who were deemed not eligible for therapy with a PD-1/L1 inhibitor by their treating physician will also be eligible in the dose expansion phase.
  • Prior treatment with chemotherapy
  • Able to take oral medications
  • Measurable and/or evaluable disease (RECIST 1.1) indicator lesion not previously irradiated
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  • Karnofsky performance status (KPS) ≥ 70% (ECOG of 0 or 1 also acceptable)
  • Age≥ 18 years old
  • Hematological and biochemical indices within the ranges shown below Hematological and biochemical indices within the ranges shown below (These measurements must be performed within two weeks [Day 14 to Day 1] before the patient is entered into the trial).
  • AST, ALT ≤ 2.5 x ULN - Total bilirubin ≤ 1.5 x ULN -Albumin≥2.5g/dL
  • Creatinine < 1.5 x ULN OR calculated creatinine clearance ≥50mL/min
  • Absolute neutrophil count (ANC) ≥ 1,200 cells/mm3
  • Hemoglobin ≥9.0 g/dL
  • Platelets ≥100,000/mm^3.
  • A negative serum pregnancy test obtained within two weeks prior to the administration of the study drug in all women of child bearing potential

Who cannot join

  • Patients with symptomatic brain metastasis requiring escalating doses of steroids
  • Patients with grade 2 or greater diarrhea prior to study initiation despite maximal medical management
  • History of any bowel disease including abdominal fistula, gastro-intestinal perforation
  • History of acute pancreatitis within 1 year of study entry or history of chronic pancreatitis
  • History of or ongoing alcohol abuse that, in the opinion of the treating physician, would compromise compliance or impart excess risks associated with study participation.
  • Pregnant or lactating women
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  • Any type of systemic therapy (chemotherapy or experimental drugs) within 3 weeks of starting treatment on protocol (within 6 weeks for for nitrosoureas and mitomycin C)
  • Radiotherapy within 2 weeks of starting treatment on protocol
  • Prior treatment with MEK, RAF, or ERK inhibitor(s)
  • Significant uncontrolled or active cardiovascular disease, specifically including, but not restricted to:
  • History of clinically significant (as determined by the treating physician) atrial arrhythmia
  • Any ventricular arrhythmia
  • History of congenital long QT syndrome.
  • Abnormal QTc (≥ 450 msec in males and ≥ 470 msec in females)
  • Ejection fraction ≤ 50% as assessed by echocardiogram
  • Concurrent congestive heart failure
  • Prior history of class III/ IV heart failure (New York Heart Association [NYHA]
  • Myocardial infarction within the last 6 months
  • Unstable angina or severe obstructive pulmonary disease
  • Patients with baseline risk factors for central serous retinopathy or retinal vein occlusion such as evidence of new optic disc cupping, evidence of new visual field defects, and intraocular pressure >21 mmHg Uncontrolled hypertension (Diastolic blood pressure > 100 mmHg; Systolic blood pressure > 150 mmHg).
  • History of central serous retinopathy or retinal vein occlusion
  • History of prior malignancy within 2 years that requires/ed treatment. Patients who are considered NED from a malignancy may be considered on a case by case basis.
  • Known active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infections
  • Patients exposed to CYP3A4 inhibitors within 7 days prior to the first dose and CYP3A4 inducers 7 days prior to the first dose. RO5126766 (CH5126766) is metabolised mainly by CYP3A4 therefore concomitant administration of strong inhibitors and inducers of cytochrome p450 3A4 enzymes is forbidden during study treatment (for a complete list please see Appendix A).
  • Any other condition that, in the opinion of the investigator, may compromise the safety, compliance of the patient, or would preclude the patient from successful completion of the study

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

  • Miami Cancer Institute

    Miami, Florida, 33143

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase 1 Trial of RO5126766 (CH5126766) in Patients With Advanced KRAS-Mutant Lung Adenocarcinomas

The purpose of this study is to test the safety of RO5126766 at different doses to find out what effects, if any, it has on people with advanced lung cancer who have previously received treatment with a PD-1 or PD-L1 inhibitor.

Being tested
RO5126766
Keywords
RO5126766 (CH5126766), KRAS-Mutant, 18-285

What participants receive

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

  • RO5126766Drug

    Also called (CH5126766)

    RO5126766 (CH5126766) is given 4mg twice weekly (Day 1 and Day 4 of each week) and should be taken by mouth on an empty stomach, either one hour before or two hours after a meal.

Study groups in NCT03681483
Study groupRoleWhat they receive
RO5126766 (CH5126766)ExperimentalThe study will begin with a standard 3+3 design. The study will enroll 3 patients at the previously identified MTD15 (4mg two times per week on days 1 and 4). The period of evaluation for dose limiting toxicity will be through completion of cycle 1. If ≤1 of the 3 initial patients at the proposed dose experience a DLT, then 3 additional patients will be enrolled for a total of 6 planned patients at that dose level. Otherwise, 3 patients will be enrolled at dose level -1. If ≤ 1 of these patients experience a DLT, then 3 additional patients will be enrolled at the same dose level. If more than 1 patient experiences a DLT in dose level -1, the study will be terminated.
Receives: Drug: RO5126766

What is being measured

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

  1. The maximum tolerated dose (MTD)

    will be defined as the highest dose level at which ≤ 1 of 6 patients experienced a DLT.The NCI Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE) will be used to grade toxicities during the trial. DLTs are defined as any toxicity occurring during the first cycle of treatment (i.e. 4 weeks), excluding toxicites clearly related to disease progression or disease-related processes.

    Measured: 1 year

  2. overall response rate (dose expansion)

    by RECIST 1.1

    Measured: 1 year

Timeline

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

  1. First posted24 Sep 2018
  2. Study start31 Oct 2018
  3. Primary completion8 Jul 2024
  4. Study completion8 Jul 2024

Resources

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
Not applicable
Intervention model
Single group
Model description
Single arm, open label, multi-institution study of RO5126766 (CH5127566) in patients with KRAS mutant NSCLC.
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03681483
Sponsor's protocol ID
18-285
Status last verified
Jul 2024
First submitted
20 Sep 2018
Last updated
10 Jul 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RO5126766 in people with Advanced Non-small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center 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 15 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 10 Jul 2024. 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?

The maximum tolerated dose (MTD) (time frame: 1 year). 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?

On the ClinicalTrials.gov record for NCT03681483.

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 10 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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