LY3039478 given orally TIW (3 times per week) in 28 day cycles. Treatment will continue until disease progression, development of unacceptable toxicity, or any other discontinuation criteria are met.

LY3039478

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The purpose of this study is to evaluate the tolerability of the study drug LY3039478 in Japanese participants with advanced solid tumors.

A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors

A Phase 1 Study of LY3039478 in Japanese Patients With Advanced Solid Tumors

Eli Lilly and Company

Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Leukemia-Lymphoma, Adult T-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Lymphosarcoma

Acute Graft Versus Host Disease

Adult T-cell Leukemia/lymphoma

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Dexamethasone acetate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

Part B: LY3039478 administered orally TIW at escalating doses and dexamethasone administered orally twice a day (BID) on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

There were no participants enrolled to Part B of the study.

LY3039478 administered orally TIW and dexamethasone administered orally BID on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

There were no participants enrolled to Phase 2 of the study.

Placebo administered orally TIW and dexamethasone administered orally BID on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

There were no participants enrolled to Phase 2 of the study.

Placebo

The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with dexamethasone in participants with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma (T-ALL/T-LBL).

A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL

A Phase 1b/Randomized Phase 2 Study to Evaluate LY3039478 in Combination With Dexamethasone in T-ALL/T-LBL Patients

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

A DLT was an Adverse Event(AE) observed during the first 28 day cycle that is determined by the investigator to be at least possibly related to LY3039478 according to CTCAE v 4.0 and fulfills any of the following criteria: CTCAE Grade 3 nonhematological toxicity with a few exceptions, any other significant toxicity deemed to be dose limiting (eg, any toxicity that is possibly related to the study medication that requires the withdrawal of the patient from the study during Cycle 1).

A DLT was an Adverse Event(AE) observed during the first 28 day cycle that is determined by the investigator to be at least possibly related to LY3039478 according to CTCAE v 4.0 and fulfills any of the following criteria:CTCAE Grade 3 nonhematological toxicity with a few exceptions, any other significant toxicity deemed to be dose limiting.A dose-limiting equivalent toxicity (DLET) was defined as an AE occurring between Day 1 and Day 28 of any cycle (other than Cycle 1) for a patient enrolled in the Phase 1 portion or in any cycle (including Cycle 1) for a patient enrolled in the Phase 2 portion that would have met the criteria for DLT if it had occurred during Cycle 1 for a patient enrolled in the Phase 1 portion.

ORR is defined as the number of participants who achieved a best overall response of either complete remission (CR) or incomplete remission (CRi). The ORR (CR and CRi) is the sum of patients achieving a CR or a CRi divided by the total number of patients randomized in that arm. CR is defined as the number of participants who achieved a best overall response of complete remission (CR), out of the total number of participants randomized in that arm.

Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC\[0-∞\]) of LY3039478 in Combination with Dexamethasone in Day 1

Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC\[0- 48\]) of LY3039478 in Combination with Dexamethasone in Day 8

ORR is defined as the number of participants who achieved a best overall response of either complete remission (CR) or incomplete remission (CRi). The ORR (CR and CRi) is the sum of participants achieving a CR or a CRi divided by the total number of participants randomized in that arm. CR is defined as the number of participants who achieved a best overall response of complete remission (CR), out of the total number of participants randomized in that arm.

Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

50 mg LY3039478 + Dexamethasone

Part A: 75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

75 mg LY3039478 + Dexamethasone

Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression

100 mg LY3039478 + Dexamethasone

Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression

125 mg LY3039478 + Dexamethasone

Part A: 100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

Part A: 125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Italy

France

Germany

Region of Enrollment

All participants who received at least one dose of study drug.

There were no participants enrolled to Part B and Phase 2 of the study.

Chief Medical Officer

All participants who received at least one dose of study drug in Part A.

Number of Participants With Dose Limiting Toxicities (DLTs)

Part A:

50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

All Participants

Recommended Dose of LY3039478 in Combination With Dexamethasone

Number of Participants Who Achieve Complete Remission (CR) or CR With Incomplete Blood Count Recovery (CRi): Overall Remission Rate (ORR)

All participants who received at least one dose of study drug in Part A and had evaluable PK data.

Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0-∞]) of LY3039478 in Combination With Dexamethasone in Day 1

Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0- 48]) of LY3039478 in Combination With Dexamethasone in Day 8

Number of Participants With CR or CRi and Notch-1 or FBXW7 Mutations

LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

LY3039478 + Dexamethasone

Placebo administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

Placebo + Dexamethasone

Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.

Phase 2: Number of Participants Who Achieve CR, CRi or Partial Remission (PR): Overall Remission Rate (ORR) Plus PR

Phase 2: Number of Participants Who Achieve PR

Phase 2: Duration of Remission (DoR)

Phase 2:Relapse Free Survival (RFS)

Phase 2: Event Free Survival (EFS)

Phase 2: Overall Survival (OS)

Phase 2: Change From Baseline in the Functional Assessment of Cancer Therapy-Leukemia-General (FACT-Leu-G) Score

Overall Study

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

Prednisone

Part A: LY3039478 administered orally three times per week (TIW) at escalating doses (2.5 milligrams \[mg\] to 100 mg) for two 28 day cycles. Participants receiving benefit may continue until disease progression

Part B, C, D and E: LY3039478 administered orally three times per week (TIW) at a fixed dose determined in Part A for two 28 day cycles. Participants receiving benefit may continue until disease progression.

Part F1: LY3039478 administered orally TIW for 28 day cycles. Prednisone will be co-administered with LY3039478 for the first 2 weeks in cycle 1 only (28 day cycles). Participants receiving benefit may continue until disease progression.

Part F2: LY3039478 administered orally TIW (twice a week in cycle 1) for 28 day cycles. Prednisone will be co-administered with LY3039478 for the first 2 weeks in cycle 1 only. Participants receiving benefit may continue until disease progression.

1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

The purpose of this study is to find a recommended dose level of LY3039478 that can safely be taken by participants with advanced cancer or cancer that has spread to other parts of the body, including but not limited to lymphoma. The study will also explore changes to various markers in blood cells and tissue. Finally, the study will help to document any tumor activity this drug may have.

In Part A of this study, participants with advanced/metastatic cancer (including lymphoma) will receive increasing doses of LY3039478 to define the dose level for Part B, C, D and E. In Part B, C, D and E LY3039478 will be explored at a predefined fixed dose level. Participants in Part B and D must have a defined alteration in a certain molecular pathway. Enrollment of participants in Part B, C, D and E will start once Part A is completed. In Part F participants will receive increasing doses of LY3039478 in combination with prednisone to define the maximum tolerated dose level.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors	NCT02836600	Advanced Solid ...	LY3039478	20 Years -	Eli Lilly and Company
A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL	NCT02518113	T-cell Acute Ly... T-cell Lymphobl...	LY3039478 Dexamethasone Placebo	2 Years -	Eli Lilly and Company
A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL	NCT02518113	T-cell Acute Ly... T-cell Lymphobl...	LY3039478 Dexamethasone Placebo	2 Years -	Eli Lilly and Company
A Study of LY3039478 in Participants With Advanced Cancer	NCT01695005	Neoplasms Neoplasm Metast... Lymphoma	LY3039478 Prednisone	18 Years -	Eli Lilly and Company
A Study of LY3039478 in Participants With Advanced Cancer	NCT01695005	Neoplasms Neoplasm Metast... Lymphoma	LY3039478 Prednisone	18 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for ly3039478

Every month we try and update this database with for ly3039478 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ly3039478

Every month we try and update this database with for ly3039478 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ly3039478 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.