Palbociclib for Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lung CancerPalbociclib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a possible treatment for lung cancer that involves two drugs.

Eligible Conditions
  • Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 3 Secondary · Reporting Duration: 2 years

15 days
Pharmacokinetics
2 Years
Safety and tolerability of Palbocilib and Binimetinib
2 years
Maximum Tolerated Dose
Objective Response
Target engagement of palbociclib and binimetinib
4 months
progression free survival

Trial Safety

Safety Progress

1 of 3

Side Effects for

Palbociclib + Fulvestrant
61%Neutropenia
38%Fatigue
29%Nausea
27%White blood cell count decreased
26%Anaemia
21%Neutrophil count decreased
21%Headache
20%Leukopenia
19%Diarrhoea
17%Constipation
15%Hot flush
15%Alopecia
14%Vomiting
13%Cough
13%Decreased appetite
13%Arthralgia
12%Thrombocytopenia
12%Stomatitis
11%Dizziness
11%Back pain
11%Dyspnoea
10%Pain in extremity
9%Rash
9%Oropharyngeal pain
8%Pyrexia
8%Platelet count decreased
8%Insomnia
7%Dyspepsia
7%Myalgia
7%Nasopharyngitis
7%Asthenia
7%Oedema peripheral
6%Abdominal pain
6%Dysgeusia
6%Injection site pain
6%Aspartate aminotransferase increased
6%Dry mouth
6%Musculoskeletal pain
6%Muscle spasms
6%Pruritus
6%Upper respiratory tract infection
6%Epistaxis
5%Depression
4%Anxiety
4%Pain
3%Musculoskeletal chest pain
3%Abdominal pain upper
2%Chest pain
1%Pulmonary embolism
1%Disease progression
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT01942135) in the Palbociclib + Fulvestrant ARM group. Side effects include: Neutropenia with 61%, Fatigue with 38%, Nausea with 29%, White blood cell count decreased with 27%, Anaemia with 26%.

Trial Design

4 Treatment Groups

Binimetinib Phase 2
1 of 4
Binimetinib Combine with Palbociclib Phase 2
1 of 4
Binimetinib Combine with Palbociclib Phase 1
1 of 4
Palbociclib Phase 2
1 of 4

Experimental Treatment

72 Total Participants · 4 Treatment Groups

Primary Treatment: Palbociclib · No Placebo Group · Phase 1 & 2

Binimetinib Phase 2
Drug
Experimental Group · 1 Intervention: Binimetinib · Intervention Types: Drug
Binimetinib Combine with Palbociclib Phase 2Experimental Group · 2 Interventions: Binimetinib, Palbociclib · Intervention Types: Drug, Drug
Binimetinib Combine with Palbociclib Phase 1Experimental Group · 2 Interventions: Binimetinib, Palbociclib · Intervention Types: Drug, Drug
Palbociclib Phase 2
Drug
Experimental Group · 1 Intervention: Palbociclib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Binimetinib
FDA approved
Palbociclib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Array BioPharmaIndustry Sponsor
28 Previous Clinical Trials
1,543 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,017 Previous Clinical Trials
393,756 Total Patients Enrolled
PfizerIndustry Sponsor
4,310 Previous Clinical Trials
7,111,552 Total Patients Enrolled
Geoffrey Shapiro, MD, PhDPrincipal Investigator - Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Joan And Stanford I. Weill Medical College Of Cornell Uni (Medical School)
Brigham & Women'S Hospital (Residency)
7 Previous Clinical Trials
223 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
, provided those therapies were not investigational and were not used to attempt to induce PDU
The patient has an ECOG performance status of less than 2.
A person's absolute neutrophil count is more than 1,500mm3.
Platelets are numbers over 100,000 per microliter.
The bilirubin level is less than twice the institutional upper limit of normal.
People who have cancer that has spread to other parts of their body and is not treatable with surgery, chemotherapy, or radiation therapy are eligible to participate in this study.
In order to participate in the study, participants must have measurable disease according to RECIST 1.1 within four weeks of study entry.
The study will only include participants with measurable disease; this is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan
Children aged 18 years or older are eligible for this study.