Description:
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.
Title
- Brief Title: A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors
- Official Title: A Phase 1b Study of LY3039478 in Combination With Other Anticancer Agents in Patients With Advanced or Metastatic Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
16209
- SECONDARY ID:
I6F-MC-JJCD
- SECONDARY ID:
2015-004421-14
- NCT ID:
NCT02784795
Conditions
- Solid Tumor
- Breast Cancer
- Colon Cancer
- Cholangiocarcinoma
- Soft Tissue Sarcoma
Interventions
Drug | Synonyms | Arms |
---|
LY3039478 | | LY3039478 + Abemaciclib |
Taladegib | LY2940680 | LY3039478 + Taladegib |
Abemaciclib | LY2835219 | LY3039478 + Abemaciclib |
Cisplatin | | LY3039478 + Cisplatin/Gemcitabine |
Gemcitabine | | LY3039478 + Cisplatin/Gemcitabine |
Carboplatin | | LY3039478 + Gemcitabine/Carboplatin |
LY3023414 | | LY3039478 + LY3023414 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
LY3039478 + Taladegib | Experimental | LY3039478 given orally 3 times per week (TIW) in combination with taladegib given orally daily on a 28 day cycle. A single dose of taladegib will also be given on day 1 during a 3-day lead-in period. | |
LY3039478 + LY3023414 | Experimental | LY3039478 given orally TIW in combination with LY3023414 given orally every 12 hours on a 28-day cycle. A single dose of LY3023414 will also be given on day 1 during a 3-day lead-in period. | |
LY3039478 + Abemaciclib | Experimental | LY3039478 given orally TIW in combination with abemaciclib given orally every 12 hours on a 28-day cycle. A single dose of abemaciclib will also be given on day 1 during a 3-day lead-in period. | |
LY3039478 + Cisplatin/Gemcitabine | Experimental | LY3039478 given orally TIW in combination with cisplatin and gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle. | - LY3039478
- Cisplatin
- Gemcitabine
|
LY3039478 + Gemcitabine/Carboplatin | Experimental | LY3039478 given orally TIW in combination with gemcitabine and carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. | - LY3039478
- Gemcitabine
- Carboplatin
|
Eligibility Criteria
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Maximum Tolerated Dose (MTD) of LY3039478 |
Time Frame: | Cycle 1 (up to 28 Days) |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Pharmacokinetics (PK): Area Under the Plasma Concentration Time Curve (AUC) of LY3039478 in Combination with Taladegib, LY3023414, Abemaciclib, Cisplatin/Gemcitabine, and Gemcitabine/Carboplatin |
Time Frame: | Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (up to 28 Day Cycles) |
Safety Issue: | |
Description: | |
Measure: | PK: AUC of Taladegib and its Active Metabolite LSN3185556, in Combination with LY3039478 |
Time Frame: | Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (up to 28 Day Cycles) |
Safety Issue: | |
Description: | |
Measure: | PK: AUC of LY3023414 in Combination with LY3039478 |
Time Frame: | Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (up to 28 Day Cycles) |
Safety Issue: | |
Description: | |
Measure: | PK: AUC of Abemaciclib and its Major Active Metabolites LSN2839567 and LSN3106726, in Combination with LY3039478 |
Time Frame: | Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (up to 28 Day Cycles) |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DoR) |
Time Frame: | Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression (Estimated up to 12 Months) |
Safety Issue: | |
Description: | |
Measure: | Progression Free Survival (PFS) |
Time Frame: | Baseline to Objective Disease Progression or Death (Estimated up to 12 Months) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Eli Lilly and Company |
Trial Keywords
Last Updated
August 17, 2020