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CDK4/6 Inhibitor

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

Q: What therapeutic purposes is Palbociclib primarily employed for?

<p>Palbociclib is commonly employed to treat <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a>, but has been found to be beneficial in treating additional malignant neoplasms, postmenopause issues and advance directives.</p>

Phase 1

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

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

MTD cohort and phase 2 component: Participants must have measurable disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

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

Who is the study for?

Adults with advanced lung cancer or solid tumors that have a specific mutation called KRAS can join this trial. They need to be in good health otherwise, with normal blood counts and organ function, and not on certain medications like warfarin. Pregnant women, those with uncontrolled illnesses, or individuals who've had recent chemotherapy/radiotherapy are excluded.Check my eligibility

What is being tested?

The trial is testing the combination of two experimental drugs: Palbociclib and PD-0325901. These drugs are being evaluated for their effectiveness against cancers that carry the KRAS mutation, especially non-small cell lung cancer (NSCLC).See study design

What are the potential side effects?

Possible side effects include issues with blood cells leading to increased infection risk or bleeding problems, liver changes affecting its function, fatigue, potential heart rhythm abnormalities (QTc prolongation), and possibly eye-related risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced, cannot be surgically removed, has a RAS mutation, and standard treatments are not effective.

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My cancer can be measured by tests or scans.

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

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I have mostly recovered from side effects of previous treatments.

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My lung cancer is confirmed to have a KRAS mutation.

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My cancer can be measured or observed but not necessarily through standard scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

AUC-12 of PD-0325901

AUC-12 of palbociclib

Cell cycle arrest by palbociclib using serum thymidine kinase 1 (TK1) assays

+11 more

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. .

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Palbociclib

2017

Completed Phase 3

~3760

PD-0325901

2014

Completed Phase 2

~170

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,078 Previous Clinical Trials

340,812 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

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

Palbociclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02022982 — Phase 1

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

Recent research and studies

clinicaltrials.govStudy

PALBOCICLIB + PD-0325901 for NSCLC & Solid Tumors

Geoffrey Shapiro, MD, PhD 2014. "PALBOCICLIB + PD-0325901 for NSCLC & Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02022982.