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CDK4/6 Inhibitor

Palbociclib + PD-0325901 for Non-Small Cell Lung Cancer & Solid Tumors

Phase 1 & 2
Waitlist Available
Led By Geoffrey Shapiro, MD. Ph.D
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
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)
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up2 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new combination drug therapy for cancers with KRAS mutations, which are common in lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer with KRAS Mutation
  • Solid Tumors

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have a type of cancer that has spread to other parts of the body and cannot be surgically removed. The cancer has a specific genetic mutation called RAS, and there are no standard treatments available to cure or control the cancer.
Participants must have a disease that can be measured by doctors.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose and Recommended Phase 2 Dose
Safety and tolerability
Secondary outcome measures
Overall Response Rate
Target engagement of palbociclib and PD-0325901

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Palbociclib and PD-0325901Experimental Treatment2 Interventions
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. .
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3
Completed Phase 2

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,058 Previous Clinical Trials
338,860 Total Patients Enrolled
Geoffrey Shapiro, MD. Ph.DPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Palbociclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02022982 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Palbociclib and PD-0325901
Non-Small Cell Lung Cancer Clinical Trial 2023: Palbociclib Highlights & Side Effects. Trial Name: NCT02022982 — Phase 1 & 2
Palbociclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02022982 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are participating in this research?

"This trial has concluded its recruitment process, having first been posted on January 1st 2014 and last updated on the 18th of January 2022. Currently, there are 2,334 studies actively recruiting patients with tumors or solid masses in addition to 136 trials for Palbociclib enrolling participants."

Answered by AI

What therapeutic purposes is Palbociclib primarily employed for?

"Palbociclib is commonly employed to treat breast cancer, but has been found to be beneficial in treating additional malignant neoplasms, postmenopause issues and advance directives."

Answered by AI

Are there any openings for participants in this investigation?

"This research endeavour is no longer in pursuit of participants. Initially posted on January 1st 2014, the study was last updated on January 18th 2022. If seeking other medical trials, 2334 are presently recruiting patients with solid tumors while 136 studies need more volunteers for Palbociclib related investigations."

Answered by AI

Is Palbociclib a relatively new experimental treatment, or have there been prior investigations into its efficacy?

"At present, there are 136 experiments probing into Palbociclib with 16 trials in their final phase. Although many of these studies originate from Burgas, New Jersey, a total of 6639 sites across the world have initiated clinical trials for this drug."

Answered by AI
~13 spots leftby Nov 2024