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CDK4/6 Inhibitor

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

Boston, MA

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

Must not have

Symptomatic brain metastases requiring chronic steroids

Concurrent use with strong CYP3A4 inhibitors/inducers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

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

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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.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need ongoing steroids for my brain metastases symptoms.

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I am not taking strong CYP3A4 inhibitors or inducers.

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I am taking Warfarin.

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I do not have any uncontrolled illnesses.

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I am HIV-positive and on combination antiretroviral therapy.

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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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose and Recommended Phase 2 Dose

Safety and tolerability

Secondary study objectives

AUC-12 of PD-0325901

AUC-12 of palbociclib

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

+11 more

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. .

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Palbociclib

2017

Completed Phase 3

~3910

PD-0325901

2014

Completed Phase 2

~170