KRAS Mutant Non-Small Cell Lung CancerPhase 1NCT02022982
PALBOCICLIB + PD-0325901 for NSCLC & Solid Tumors
A Phase 1 study testing Palbociclib and PD-0325901 in people with KRAS Mutant Non-Small Cell Lung Cancer and Solid Tumors, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is evaluating the experimental drug palbociclib in combination with another experimental drug PD-0325901 as a possible treatment for cancers with KRAS mutations, particularly for those which started in the lung. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- KRAS Mutant Non-Small Cell Lung Cancer, Solid Tumors
- What is being tested?
- Palbociclib and PD-0325901
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 30 Jun 2021
- 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
- Dose-escalation/MTD cohorts, participants must have histologically confirmed malignancy with a RAS mutation that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. For the randomized phase 2 component of the study, participants must have histologically confirmed NSCLC with a confirmed KRAS mutation (via any CLIA-certified method)
- For the dose-escalation component, participants are required to have only evaluable disease. For the MTD cohort and phase 2 component of the study, participants must have measurable disease.
- Participants enrolled to the MTD cohort must agree to pre and on-treatment tumor biopsies if assessable disease is identified.
- Age ≥18 years.
- ECOG performance status ≤ 2 (see Appendix A).
- Participants must have normal organ and marrow function as defined below:
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- Absolute neutrophils count ≥ 1,500/mcL
- Platelets ≥100,000/mcL
- total bilirubin within normal institutional limits
- AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal (≤ 5.0 X institutional upper limit of normal permitted if hepatic metastases present)
- Creatinine within 1.5x the ULN institutional limits.
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Ability to understand and the willingness to sign a written informed consent document.
- QTc ≤480 msec.
- The availability of archival tissue to evaluate retrospectively the participant's Rb status
- Patients must have recovered to ≤ Grade 1 in terms of toxicity from prior treatments (excluding neuropathy which can be ≤ Grade 2).
Who cannot join
- Participants who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
- Participants may not be receiving any other study agents concurrently with the study drugs.
- Participants with symptomatic brain metastases that require chronic steroids are excluded. Patients with a history of brain metastases are permitted to enroll as long as they have been treated, off of steroids and have been stable for one month on imaging.
- Concurrent use with strong CYP3A4 inhibitors/inducers is prohibited due to drug-drug interactions with palbociclib.
- Due to potential drug interactions between warfarin and PD-0325901, warfarin use is excluded. Other anticoagulants are permitted.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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- Pregnant women are excluded from this study because the study agents have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with the study agents, breastfeeding should be discontinued.
- For Part II only: Individuals with a history of a different malignancy are ineligible except if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
- HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions.
- Evidence of visible retinal pathology on screening ophthalmologic examination that places the participant at an unacceptable risk for ocular toxicity, such as risk factors for retinal vein occlusion, related to PF-0325901.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Phase I Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the MEK Inhibitor PD-0325901 for Patients With KRAS Mutant Non-Small Cell Lung Cancer and Other Solid Tumors
This research study is evaluating the experimental drug palbociclib in combination with another experimental drug PD-0325901 as a possible treatment for cancers with KRAS mutations, particularly for those which started in the lung.
Read the detailed description
This will be an open label Phase I dose escalation study evaluating the combination of the CDK4/6 inhibitor palbociclib (PD-0332991) and the MEK inhibitor PD-0325901. To determine the maximally tolerated dose (MTD) and recommended phase 2 dose (RP2D), a 3+3 dose escalation protocol will be undertaken. Once the RP2D has been determined, the study will then evaluate, in a randomized phase II study design, the combination of palbociclib and PD-0325901 compared to PD-0325901 alone and palbociclib alone in KRAS mutant NSCLC.
- Phase 1: The investigators are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have cancer, not everyone who participates in this research study will receive the same dose of the study drug. The dose the participant receives will depend on the number of participants who have been enrolled in the study before and how well the dose has been tolerated.
- Study Drug(s): The participant will be given a study drug-dosing calendar for each treatment cycle. Each treatment cycle lasts 4 weeks during which time you will be taking the study drug for 3 weeks at a time. The participant will take Palbociclib by mouth once a day, every day for 3 weeks. The participant will take PD-0325901 by mouth twice a day, every day for 3 weeks.
- Clinical Exams: During all cycles the participant will have a physical exam and will be asked questions about general health and specific questions about any problems that they might be having and any medications they may be taking.
- Scans (or Imaging tests): The investigators will assess the participant's tumor by either a CT scan or MRI
- Blood Tests: These are special tests to check the amount of drug and the amount of tumor DNA in the participant's blood at specific points in time.
Secondary Outcomes:
- Evaluate PK parameters for the combination of palbociclib and PD-0325901
- Confirm target engagement of palbociclib and PD-0325901 in patients undergoing pre- and on-treatment biopsies in an expansion cohort at the MTD
- Evaluate preliminary clinical efficacy of the combination of palbociclib and PD-0325901 in patients with tumors harboring KRAS mutations.
- Being tested
- Palbociclib, PD-0325901
- Keywords
- KRAS mutant Non-Small Cell Lung Cancer, Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Also called PD 0332991-00
Palbociclib will be administered orally once daily, 3 weeks out of every 4 in each cycle. The initial dose for phase 1 of the study will be 75 mg daily. Dosing will be adjusted until Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) are established. No pre-medications for palbociclib are required. It should be administered without food with patients fasting for 1 hour prior and 2 hours post drug administration.
PD-0325901Drug
Also called PD-0325901-0000, PF-00192513-00
PD-0325901 will be administered orally twice daily, 3 weeks out of every 4 in each cycle. The initial dose for phase 1 of the study will be 2 mg twice daily. Dosing will be adjusted until Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) are established. PD-0325901 will be administered using a flat-dosing plan. No premedications are required. As the effect of food on PD-0325901 is uncertain, patients will be permitted to dose either fasting or after food.
| Study group | Role | What they receive |
|---|---|---|
| Palbociclib and PD-0325901 | Experimental | * Palbociclib by mouth once a day, every day for 3 weeks every 4 in each cycle.
* PD-0325901 by mouth twice a day, every day for 3 weeks every 4 in each cycle. . Receives: Drug: Palbociclib; Drug: PD-0325901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Toxicities will be graded using version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Measured: 2 Years
Maximum Tolerated Dose and Recommended Phase 2 Dose
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 RP2D.
Measured: 2 years
Secondary outcomes (14)
Maximum plasma concentration (Cmax) of palbociclib
Cmax (ng/ml) of palbociclib will be assessed utilizing serial blood draws on cycle 1 day 1 and on cycle 1 day 15 (steady state).
Measured: 1 month
Time to maximum concentration (tmax) of palbociclib
tmax (h) of palbociclib will be assessed utilizing serial blood draws on cycle 1 day 1 and on cycle 1 day 15 (steady state).
Measured: 1 month
AUC-12 of palbociclib
The AUC-12 (ng.h/ml) of palbociclib will be assessed utilizing serial blood draws on cycle 1 day 1 and on cycle 1 day 15 (steady state).
Measured: 1 month
Clearance (CL/F) of palbociclib
Clearance (L/h) of palbociclib will be assessed utilizing serial blood draws on cycle 1 day 1 and on cycle 1 day 15 (steady state).
Measured: 1 month
Maximum plasma concentration (Cmax) of PD-0325901
Cmax (ng/ml) of PD-0325901 will be assessed utilizing serial blood draws on cycle 1 day 1 and on cycle 1 day 15 (steady state).
Measured: 1 month
Time to maximum concentration (tmax) of PD-0325901
tmax of PD-0325901 will be assessed utilizing serial blood draws on cycle 1 day 1 and on cycle 1 day 15 (steady state).
Measured: 1 month
AUC-12 of PD-0325901
AUC-12 (ng.h/ml) of PD-0325901 will be assessed utilizing serial blood draws on cycle 1 day 1 and on cycle 1 day 15 (steady state).
Measured: 1 month
Clearance (CL/F ) of PD-0325901
Clearance (L/h) of PD-0325901 will be assessed utilizing serial blood draws on cycle 1 day 1 and on cycle 1 day 15 (steady state).
Measured: 1 month
Target engagement of palbociclib by immunohistochemistry (IHC) of phospho-Rb in tumor
IHC for phospho-Rb will be performed in pre- and on-treatment tumor biopsies to assess palbociclib target engagement.
Measured: 2 Years
Target engagement of palbociclib by immunohistochemistry (IHC) of phospho-Rb in skin
IHC for phospho-Rb will be performed in pre- and on-treatment skin biopsies to assess palbociclib target engagement.
Measured: 2 Years
Target engagement of PD-0325901 by immunohistochemistry (IHC) of phospho-ERK in tumor
IHC for phospho-ERK will be performed in pre- and on-treatment tumor biopsies to assess PD-0325901 target engagement.
Measured: 2 Years
Cell cycle arrest by palbociclib using serum thymidine kinase 1 (TK1) assays
Serial serum collections (pre- and on-treatment) will be assayed for TK1 activity to assess cell cycle arrest mediated by palbociclib.
Measured: 2 Years
Quantitative non-invasive genotyping for KRAS in cfDNA
Serial cfDNA samples will be collected and assessed for KRAS plasma allellic burden as a measure of anti-tumor activity of the combination of palbociclib and PD-0325901.
Measured: 2 Years
Overall Response Rate
The preliminary clinical efficacy of palbociclib and PD-0325901 in advanced KRAS-mutant solid tumors will be assessed using CT and MRI scans per RECIST version 1.1.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startJan 2014
- Primary completion1 Nov 2017
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KRAS Mutant Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- Geoffrey Shapiro, MD. Ph.D, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022982
- Sponsor's protocol ID
- 13-506
- Status last verified
- Mar 2024
- First submitted
- 23 Dec 2013
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the MEK Inhibitor PD-0325901 for Patients With KRAS Mutant Non-Small Cell Lung Cancer and Other Solid Tumors
- ClinicalTrials.gov ID
- NCT02022982
- Acronym / sponsor ID
- 13-506
- Keywords
- KRAS mutant Non-Small Cell Lung Cancer, Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 30 Dec 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 research study is evaluating the experimental drug palbociclib in combination with another experimental drug PD-0325901 as a possible treatment for cancers with KRAS mutations, particularly for those which started in the lung.
Detailed description
This will be an open label Phase I dose escalation study evaluating the combination of the CDK4/6 inhibitor palbociclib (PD-0332991) and the MEK inhibitor PD-0325901. To determine the maximally tolerated dose (MTD) and recommended phase 2 dose (RP2D), a 3+3 dose escalation protocol will be undertaken. Once the RP2D has been determined, the study will then evaluate, in a randomized phase II study design, the combination of palbociclib and PD-0325901 compared to PD-0325901 alone and palbociclib alone in KRAS mutant NSCLC.
- Phase 1: The investigators are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have cancer, not everyone who participates in this research study will receive the same dose of the study drug. The dose the participant receives will depend on the number of participants who have been enrolled in the study before and how well the dose has been tolerated.
- Study Drug(s): The participant will be given a study drug-dosing calendar for each treatment cycle. Each treatment cycle lasts 4 weeks during which time you will be taking the study drug for 3 weeks at a time. The participant will take Palbociclib by mouth once a day, every day for 3 weeks. The participant will take PD-0325901 by mouth twice a day, every day for 3 weeks.
- Clinical Exams: During all cycles the participant will have a physical exam and will be asked questions about general health and specific questions about any problems that they might be having and any medications they may be taking.
- Scans (or Imaging tests): The investigators will assess the participant's tumor by either a CT scan or MRI
- Blood Tests: These are special tests to check the amount of drug and the amount of tumor DNA in the participant's blood at specific points in time.
Secondary Outcomes:
- Evaluate PK parameters for the combination of palbociclib and PD-0325901
- Confirm target engagement of palbociclib and PD-0325901 in patients undergoing pre- and on-treatment biopsies in an expansion cohort at the MTD
- Evaluate preliminary clinical efficacy of the combination of palbociclib and PD-0325901 in patients with tumors harboring KRAS mutations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palbociclib and PD-0325901 | Experimental | Drug: Palbociclib, Drug: PD-0325901* Palbociclib by mouth once a day, every day for 3 weeks every 4 in each cycle. * PD-0325901 by mouth twice a day, every day for 3 weeks every 4 in each cycle. . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Dose-escalation/MTD cohorts, participants must have histologically confirmed malignancy with a RAS mutation that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. For the randomized phase 2 component of the study, participants must have histologically confirmed NSCLC with a confirmed KRAS mutation (via any CLIA-certified method)
- For the dose-escalation component, participants are required to have only evaluable disease. For the MTD cohort and phase 2 component of the study, participants must have measurable disease.
- Participants enrolled to the MTD cohort must agree to pre and on-treatment tumor biopsies if assessable disease is identified.
- Age ≥18 years.
- ECOG performance status ≤ 2 (see Appendix A).
Key exclusion criteria (10 listed)
- Participants who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
- Participants may not be receiving any other study agents concurrently with the study drugs.
- Participants with symptomatic brain metastases that require chronic steroids are excluded. Patients with a history of brain metastases are permitted to enroll as long as they have been treated, off of steroids and have been stable for one month on imaging.
- Concurrent use with strong CYP3A4 inhibitors/inducers is prohibited due to drug-drug interactions with palbociclib.
- Due to potential drug interactions between warfarin and PD-0325901, warfarin use is excluded. Other anticoagulants are permitted.
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 |
|---|---|---|
| PalbociclibAlso: PD 0332991-00Palbociclib will be administered orally once daily, 3 weeks out of every 4 in each cycle. The initial dose for phase 1 of the study will be 75 mg daily. Dosing will be adjusted until Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) are established. No pre-medications for palbociclib are required. It should be administered without food with patients fasting for 1 hour prior and 2 hours post drug administration. | Drug | Palbociclib and PD-0325901 |
| PD-0325901Also: PD-0325901-0000, PF-00192513-00PD-0325901 will be administered orally twice daily, 3 weeks out of every 4 in each cycle. The initial dose for phase 1 of the study will be 2 mg twice daily. Dosing will be adjusted until Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) are established. PD-0325901 will be administered using a flat-dosing plan. No premedications are required. As the effect of food on PD-0325901 is uncertain, patients will be permitted to dose either fasting or after food. | Drug | Palbociclib and PD-0325901 |
Primary outcome
Safety and tolerability
Time frame: 2 Years
Toxicities will be graded using version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Maximum Tolerated Dose and Recommended Phase 2 Dose
Time frame: 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 RP2D.
14 secondary outcomes
Maximum plasma concentration (Cmax) of palbociclib
Time frame: 1 month
Time to maximum concentration (tmax) of palbociclib
Time frame: 1 month
AUC-12 of palbociclib
Time frame: 1 month
Clearance (CL/F) of palbociclib
Time frame: 1 month
Maximum plasma concentration (Cmax) of PD-0325901
Time frame: 1 month
Time to maximum concentration (tmax) of PD-0325901
Time frame: 1 month
AUC-12 of PD-0325901
Time frame: 1 month
Clearance (CL/F ) of PD-0325901
Time frame: 1 month
Target engagement of palbociclib by immunohistochemistry (IHC) of phospho-Rb in tumor
Time frame: 2 Years
Target engagement of palbociclib by immunohistochemistry (IHC) of phospho-Rb in skin
Time frame: 2 Years
Target engagement of PD-0325901 by immunohistochemistry (IHC) of phospho-ERK in tumor
Time frame: 2 Years
Cell cycle arrest by palbociclib using serum thymidine kinase 1 (TK1) assays
Time frame: 2 Years
Quantitative non-invasive genotyping for KRAS in cfDNA
Time frame: 2 Years
Overall Response Rate
Time frame: 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 19 Mar 2024.
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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.
Geoffrey Shapiro, MD. Ph.D principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Palbociclib and PD-0325901 in people with KRAS Mutant Non-Small Cell Lung Cancer and Solid Tumors, run by Dana-Farber Cancer Institute at 1 site 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 10 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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Safety and tolerability (time frame: 2 Years). 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?
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 19 Mar 2024.