A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors

Breast Cancer Clinical Trial

Official title:

A Phase 1b Study of LY3039478 in Combination With Other Anticancer Agents in Patients With Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784795
• Other study ID #: 16209
• Secondary ID: I6F-MC-JJCD2015-
• Status: Completed
• Phase: Phase 1
• Start date: November 4, 2016
• Est. completion date: February 13, 2020

Study information

• Verified date: August 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with other anticancer agents in participants with advanced or metastatic solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: February 13, 2020
• Est. primary completion date: August 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• For all parts: The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their advanced or metastatic cancer.

• For dose escalation for all combinations: The participant must have histological or cytological evidence of cancer, either a solid tumor or a lymphoma, which is advanced or metastatic.

• For Part A dose confirmation: All participants must have histological evidence of advanced or metastatic soft tissue sarcoma or breast cancer. Breast cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.

• For Part B dose confirmation: All participants must have histological evidence of advanced or metastatic colon cancer or soft tissue sarcoma. Colon cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.

• For Part C dose confirmation: All participants must have histological evidence of advanced or metastatic breast cancer and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.

• For Part D dose confirmation: All participants must have histological evidence of cholangiocarcinoma and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway. Participants must not have received >1 line of prior systemic therapy for metastatic or resectable disease (that is, participants may have received adjuvant gemcitabine and then later gemcitabine/cisplatin for recurrent metastatic disease).

• For Part E dose confirmation: All participants must have histological evidence of locally advanced or metastatic triple negative breast cancer (TNBC) and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway. Participants must not have received >2 lines of systemic treatment for advanced or metastatic TNBC.

• Have adequate organ function.

• Have a performance status of =1 on the Eastern Cooperative Oncology Group (ECOG) scale.

• Have discontinued all previous therapies for cancer.

Exclusion Criteria:

• Have current acute leukemia.

• Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease.

Related Conditions & MeSH terms

• Breast Cancer
• Cholangiocarcinoma
• Colon Cancer
• Sarcoma
• Soft Tissue Sarcoma
• Solid Tumor

Intervention

Drug:
• LY3039478
Administered orally
• Taladegib
Administered orally
• Abemaciclib
Administered orally
• Cisplatin
Administered IV
• Gemcitabine
Administered IV
• Carboplatin
Administered IV
• LY3023414
Administered orally

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	København Ø
France	Institut Bergonie	Bordeaux
France	Centre Leon Berard	Lyon Cedex 08
France	Gustave Roussy	Villejuif Cedex
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Fundacion Jimenez Diaz	Madrid
Spain	Hospital Madrid Norte Sanchinarro	Madrid
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Denmark,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD) of LY3039478		Cycle 1 (up to 28 Days)
Secondary	Pharmacokinetics (PK): Area Under the Plasma Concentration Time Curve (AUC) of LY3039478 in Combination with Taladegib, LY3023414, Abemaciclib, Cisplatin/Gemcitabine, and Gemcitabine/Carboplatin		Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (up to 28 Day Cycles)
Secondary	PK: AUC of Taladegib and its Active Metabolite LSN3185556, in Combination with LY3039478		Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (up to 28 Day Cycles)
Secondary	PK: AUC of LY3023414 in Combination with LY3039478		Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (up to 28 Day Cycles)
Secondary	PK: AUC of Abemaciclib and its Major Active Metabolites LSN2839567 and LSN3106726, in Combination with LY3039478		Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (up to 28 Day Cycles)
Secondary	Duration of Response (DoR)		Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression (Estimated up to 12 Months)
Secondary	Progression Free Survival (PFS)		Baseline to Objective Disease Progression or Death (Estimated up to 12 Months)

External Links

•   Click here for more information about this study:A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors