Trials Sponsors Conditions Drugs Pricing

Conditions

Endometrial Cancer Recurrent Endometrial Cancer

Keywords

LY302341415-079Persistent Endometrial Cancer

Outcome Measures

Primary Outcomes (2)

Clinical Benefit Rate (CBR)
defined as the percentage of patients with complete response (CR) + partial response (PR) + stable disease (SD) ≥12 weeks from the start of treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
12 weeks from baseline up to a year
Overall Response Rate
determined by RECIST 1.1.
1 year

Secondary Outcomes (3)

Progression Free Survival (PFS)
1 year
Duration of Response (DOR)
1 year
Number of Participants Assessed for AE's With PI3K Activated Recurrent/Persistent Endometrial Cancer
1 year

Study Arms (1)

LY3023414

EXPERIMENTAL

This is an MSKCC investigator-initiated, single-center, non-randomized, open-label, phase II study to evaluate the activity of LY3023414 dosed at the RP2D of 200 mg orally twice daily in patients with recurrent or persistent endometrial cancer.

Drug: LY3023414

Interventions

LY3023414Drug

Enrolled patients will take LY3023414 200 mg orally twice a day. Each cycle will be 21 days in duration. Patients will receive study treatment until disease progression, intolerable toxicity, elective withdrawal from the study, study completion, or study termination

LY3023414

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients must have recurrent or persistent endometrial carcinoma Patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, transitional cell carcinoma, and carcinosarcoma.

Sponsors & Collaborators

Eli Lilly and Company
Industrycollaborator
Memorial Sloan Kettering Cancer Center
Otherlead

Study Sites (6)

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

LY3023414

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Results Point of Contact

Title: Dr. Vicky Makker, MD
Organization: Memorial Sloan Kettering Cancer Center

Study Officials

Vicky Makker, MD
Memorial Sloan Kettering Cancer Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

28 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 11, 2015

First Posted

September 15, 2015

Study Start

September 2015

Actual (reported)

You may not qualify if:

Patients with known concurrent activating RAS/RAF mutation or loss of function mutation or deletion in NF1 of NF2 resulting in MAP kinase pathway activation. Patients are not required to be evaluated for these alterations if not already performed.
Patients with diabetes requiring insulin or requiring more than one non-insulin hypoglycemia agents.
Patients previously treated with an mTOR, AKT, or PI3K inhibitor (including but not limited to GDC-0941, GDC-0980, BEZ235, BKM120, LY294002, PIK-75, TGX-221, XL147, XL765, SF1126, PX-866, D-87503, D-106669, GSK615, CAL101, everolimus, temsirolimus, and ridaforolimus). For agents not listed, the Study PI or Co-PI will make a determination.
History of myocardial infarction or unstable angina within 6 months prior to first study treatment.
New York Heart Association Class II or greater congestive heart failure.
Patients with a QTcF interval of \>450 msec on screening electrocardiogram (ECG) Note: If \>450 msec on the first ECG, 2 additional ECGs can be ordered same day and then the average may be used to determine eligibility.
History of malabsorption syndrome or other condition that would interfere with enteral absorption.
Inability or unwillingness to swallow pills
Clinically significant history of liver disease, including cirrhosis and current alcohol abuse.
Active hepatitis B or hepatitis C infection. Patients with previously resolved hepatitis B infection are eligible. Presence of positive test results for hepatitis B infection who have resolved the infection (defined by being positive for HB surface antibody (anti-HBs) and polymerase chain reaction (PCR) assay is negative for HBV DNA) are eligible. Patients positive for HCV antibody are eligible only if testing for HCV RNA is negative.
Known HIV infection.
Need for current chronic corticosteroid therapy (≥ 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids)
Pregnancy, lactation, or breastfeeding
Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
Major surgical procedure or significant traumatic injury within 28 days prior to Day 1 or anticipation of the need for major surgery during the course of study treatment.
+8 more criteria

Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

LY3023414

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

LY3023414

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations