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CDK4/6 Inhibitor

LY2835219 for Cancer

Phase 1

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to study completion (approximately 38 months)

Awards & highlights

Study Summary

This trial will study the safety and effectiveness of LY2835219 in people with advanced cancer.

Eligible Conditions

Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to study completion (approximately 38 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to study completion (approximately 38 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to study completion (approximately 38 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with clinically significant effects (physical assessments and safety lab tests)

Secondary outcome measures

Number of participants with tumor response

Pharmacokinetics, area under the curve (AUC)

Pharmacokinetics, maximum plasma concentration (Cmax)

+1 more

Side effects data

From 2019 Phase 1 trial • 12 Patients • NCT02014129

67%

Thrombocytopenia

67%

Decreased appetite

67%

Leukopenia

67%

Neutropenia

67%

Blood creatinine increased

33%

Rhinitis

33%

Diarrhoea

33%

Lymphocyte count decreased

33%

Nausea

33%

Weight decreased

33%

Pyrexia

33%

Fatigue

33%

Post procedural haemorrhage

33%

Hyponatraemia

33%

Hypoalbuminaemia

33%

Vomiting

33%

Biliary tract infection

33%

Electrocardiogram qt prolonged

33%

Malaise

33%

Proteinuria

33%

Hiccups

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1 - 100 mg Abemaciclib

Cohort 2 - 150 mg Abemaciclib

Cohort 3 - 200 mg Abemaciclib

Trial Design

1Treatment groups

Experimental Treatment

Group I: LY2835219Experimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

FDA approved

Abemaciclib

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,619 Previous Clinical Trials

3,206,374 Total Patients Enrolled

Study DirectorEli Lilly and Company

1,347 Previous Clinical Trials

405,520 Total Patients Enrolled

Frequently Asked Questions

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

How many participants are in the process of being admitted to this clinical study?

"Unfortunately, the window to join this research has since closed. The trial was originally posted in December 2009 and received its final edit on October 4th 2021. However, there are currently 2468 studies recruiting cancer patients and 204 actively searching for participants trialing LY2835219."

Answered by AI

Are there any slots left for participants in this experiment?

"As evidenced by the clinicaltrials.gov platform, this trial is not presently enrolling participants. Despite originally being posted on December 7th 2009, and last edited October 4th 2021; there are 2672 other trials actively recruiting at present."

Answered by AI

To what maladies is LY2835219 typically prescribed?

"LY2835219 is an approved intervention that can target pik3ca gene mutation, advanced hr+ her2- breast cancer, and malignant neoplasms."

Answered by AI

Does LY2835219 pose any significant risks to patients?

"The scant data regarding LY2835219's safety and efficacy resulted in a score of 1."

Answered by AI

Could you elaborate on the previous research conducted with LY2835219?

"At this moment in time, 204 studies are ongoing regarding LY2835219. Of these trials, 41 have progressed to Phase 3. Despite the majority being based out of Alicante and Pamplona/Iruña, a total of 9763 sites worldwide are running research related to this medication."

Answered by AI

Recent research and studies

Investigational New DrugsJournal

Preclinical Characterization of the CDK4/6 Inhibitor LY2835219: In-vivo Cell Cycle-dependent/independent Anti-tumor Activities Alone/in Combination with Gemcitabine

Gelbert, Lawrence M., Shufen Cai, Xi Lin, Concepcion Sanchez-Martinez, Miriam del Prado, Maria Jose Lallena, Raquel Torres, et al.. 2014. “Preclinical Characterization of the CDK4/6 Inhibitor LY2835219: In-vivo Cell Cycle-dependent/independent Anti-tumor Activities Alone/in Combination with Gemcitabine”. Investigational New Drugs. Springer Science and Business Media LLC. doi:10.1007/s10637-014-0120-7.

Clinical PharmacokineticsJournal

A Population Pharmacokinetic and Pharmacodynamic Analysis of Abemaciclib in a Phase I Clinical Trial in Cancer Patients

Tate, Sonya C., Amanda K. Sykes, Palaniappan Kulanthaivel, Edward M. Chan, P. Kellie Turner, and Damien M. Cronier. 2017. “A Population Pharmacokinetic and Pharmacodynamic Analysis of Abemaciclib in a Phase I Clinical Trial in Cancer Patients”. Clinical Pharmacokinetics. Springer Science and Business Media LLC. doi:10.1007/s40262-017-0559-8.

clinicaltrials.govStudy

A Phase 1 Study of LY2835219 In Participants With Advanced Cancer

2009. "A Phase 1 Study of LY2835219 In Participants With Advanced Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01394016.