Trial · NCT03170206
Study of Palbociclib in Combination With Binimetinib for Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer
NCT03170206, Phase 1, Completed, Dana-Farber Cancer Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Palbociclib in Combination With Binimetinib for Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer. Trials, record NCT03170206. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03170206
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Palbociclib in Combination With Binimetinib for Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer
- NCT number
- NCT03170206
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 34 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Lung Cancer
- Interventions
- Binimetinib, Palbociclib
- First posted
- 2017-05-30
- Last updated
- 2026-02-12
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose | 2 years | A standard 3+3 design will be implemented to discover the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of the combination of study drugs. A dose will be declared the MTD if zero or 1 patient out of 6 experience a dose limiting toxicity (DLT) at the highest dose level below the maximally administered dose. This is generally the Recommended Phase 2 dose- RP2D |
| Primary | Safety and tolerability of Palbocilib and Binimetinib | 2 Years | Toxicities will be graded using version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE). |
| Primary | progression free survival | 4 months | Determine the proportion of patients who are alive and progression-free at 4 months in the binimetinib, palbociclib and combination arms. |
| Secondary | Pharmacokinetic parameters of palbociclib and binimetinib | 15 days | The pharmacokinetic properties-Cmax maximum plasma concentration for the combination of palbociclib and binimetinib will be evaluated utilizing serial blood draws on cycle 1 day 1 and a steady state trough level drawn on cycle 1 day 15. |
| Secondary | Target engagement of palbociclib and binimetinib | 2 years | Confirm target engagement of palbociclib and binimetinib in pre- and on-treatment tumor biopsies from patients enrolled to an MTD expansion cohort. |
| Secondary | Objective Response | 2 years | Determine the best objective response rate, as determined by RECIST 1.1, of the combination of palbociclib and binimetinib, palbociclib alone and binimetinib alone in patients with advanced KRAS mutant NSCLC. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03170206
GET https://conductscience.org/api/trials/v1/NCT03170206/registered