Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

Idarubicin

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Dose Escalation Phase: Starting dose level of LY2510924 is 10 mg subcutaneously each day of a 28 day cycle. Dose escalated in successive cohorts of patients. On Day 8, LY2510924 administered after bone marrow aspiration and/or biopsy is performed.

Dose Expansion Phase: LY2510924 given at the maximum tolerated dose (MTD) from Dose Escalation Phase.

Dose Escalation Phase: Idarubicin 12 mg/m2 by vein given on Days 8 and 9 of a 28 day cycle. In patients \> 60 years of age Idarubicin given for 2 days.

Dose Expansion Phase: Idarubicin 8 mg/m2 by vein for 2 days.

Dose Escalation Phase: Cytarabine 1.5 gm/m2 by vein daily for 4 days (age \< 60 years). In patients \> 60 years of age Cytarabine given for 3 days only.

Dose Expansion Phase: Cytarabine 0.75 gm/m2 by vein for 3 days.

Dose Escalation Phase: Starting dose level of LY2510924 is 10 mg subcutaneously each day of a 28 day cycle. Dose escalated in successive cohorts of patients.

Dose Expansion Phase: LY2510924 given at the maximum tolerated dose (MTD) from Dose Escalation Phase.

LY2510924

Dose Escalation Phase: Idarubicin 12 mg/m2 by vein given on Days 8 and 9 of a 28 day cycle. In patients \> 60 years of age Idarubicin given for 2 days.

Dose Expansion Phase: Idarubicin 8 mg/m2 by vein for 2 days.

Dose Escalation Phase: Cytarabine 1.5 gm/m2 by vein daily for 4 days (age \< 60 years). In patients \> 60 years of age Cytarabine given for 3 days only.

Dose Expansion Phase: Cytarabine 0.75 gm/m2 by vein for 3 days.

Marina Konopleva, MD, PHD

The goal of this clinical research study is to learn about the safety of LY2510924 in combination with cytarabine and idarubicin in patients with relapsed or refractory AML. We will also study if LY2510924 in combination with cytarabine and idarubicin can help to control relapsed or refractory AML.

LY2510924 is designed to help cancer cells move from the bone marrow into the bloodstream, where they are exposed to chemotherapy (in this case, cytarabine and idarubicin).

This is an investigational study. LY2510924 is not FDA approved or commercially available. Its use in this study is investigational. Cytarabine and idarubicin are approved to treat certain types of leukemia. Their use in this study in combination with LY2510924 is investigational.

Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 3 groups of up to 6 participants each will be enrolled in the Dose Escalation part of the study, and up to 18 participants will be enrolled in Dose Expansion part of the study.

If you are enrolled in the Dose Escalation part of the study, the dose of LY2510924 you receive will depend on when you join this study. The first group of participants will receive the lowest dose level of LY2510924. Each new group will receive a higher dose of LY2510924 than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of LY2510924 is found.

If you are enrolled in the Dose Expansion part of the study, you will receive LY2510924 at the highest dose that was tolerated in the Dose Expansion part of the study.

All participants will also receive idarubicin and cytarabine. Your dose level will be assigned based on your age.

Study Drug Administration:

Treatment on this study is given in 2 phases: Induction and Consolidation. Each phase is made up of 28-day study cycles.

Induction Phase:

You will receive 1-2 cycles during the Induction phase. During Cycle 1, you will be admitted to the inpatient Leukemia service when you receive the study drugs.

You will receive LY2510924 alone each day for 7 days and then together with chemotherapy on Days 8, 9 and 10 and also on Day 11 if you are under the age of 60, of every 28-day cycle.

* On days that you do not receive idarubicin/cytarabine, LY2510924 will be given as an injection under the skin at about 8:00 am (+/- 1½ hours).
* On days when you do receive idarubicin/cytarabine, it will be given about 4 hours (+/- ½ hour) before you receive idarubicin.

On Days 8 and 9, in addition to LY2510924:

* You will receive idarubicin by vein over about 1 hour.
* You will receive cytarabine by vein over about 24 hours.

On Day 10, in addition to LY2510924:

* You will receive cytarabine by vein over about 24 hours.
* If you are under age 60, you will receive idarubicin by vein over about 1 hour.

If you are under age 60, on Day 11, in addition to LY2510924, you will receive cytarabine by vein over about 24 hours.

On days that you are receiving the cytarabine infusions, you will receive drugs to help reduce the risk of side effects. You will receive dexamethasone before the cytarabine infusion by vein over about 30 minutes. You will also receive corticosteroid-containing eye drops during this time and for 2 days following the last dose of cytarabine.

If the disease does not respond during Cycle 1, you may be allowed to receive an additional Induction cycle, which will also be called Cycle 1.If you do respond to Induction, you can move to the Consolidation phase.

Consolidation Phase:

If you are benefitting from the treatment, you may continue with Consolidation therapy for an additional 4-6 cycles.

During these cycles, you will receive LY2510924 in the same way as during earlier cycles, for 3 days with chemotherapy. During Consolidation, all participants will receive idarubicin by vein over 1 hour on Days 1 and 2, and cytarabine by vein over 24 hours on Days 1-3.

Study Visits:

During Days 1-12 of Cycle 1 (if over the age of 60, Days 1-10), blood (about 4 teaspoons) will be drawn for routine tests. During Days 1-7, blood (about 2 teaspoons) will be drawn 4 hours after your injection with LY2510924 for routine tests.

On Days 8 and 28 of Cycle 1, you will have a bone marrow biopsy/aspirate to check the status of the disease.

After Day 11 of Cycle 1, blood (about 4 teaspoons) will be drawn every 2-4 days for routine tests.

Every 1-2 weeks during Cycles 2-6, blood (about 4 teaspoons) will be drawn for routine tests.

Every 2-4 weeks during Cycles 2-6, you will have a physical exam.

After Cycles 4 and 6, you will have a bone marrow biopsy and aspiration to check the status of the disease. You will also have an EKG and either an ECHO or MUGA scan.

Any time the doctor thinks it is needed, you will have additional blood tests.

Length of Study:

You may receive up to 8 cycles of the study drugs. You will be taken off study if the disease gets worse, you experience intolerable side effects, or if the study doctor thinks it is in your best interest.

Your participation on this study will be over after you complete the End-of-Treatment Visit.

End-of-Treatment Visit:

About 30 days (+/- 5 days) after your last dose of the study drugs, blood (about 2 teaspoons) will be drawn for routine tests.

Long Term Follow-up:

Every 2-3 months for up to 2 years after you stop receiving the study drugs, blood (about 4 teaspoons) will be drawn for routine tests. This can be performed at your local doctor's office. You should also have a bone marrow aspiration/biopsy every 3 months for the first year, and then more after that if the doctor thinks it is in your best interest. If any of these tests show abnormal results, you will return to the study clinic for follow-up testing.

LY2510924, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia

A Phase 1b, Open-label Study of LY2510924, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Dose-limiting toxicity (DLT) defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness or concomitant medications. To be considered a DLT such toxicity must be possibly, probably or definitely related to LY2510924. Toxicity evaluated using the National Cancer Institute (NCI) Version 4.0 criteria.

International Working Group Criteria used to define response.

Complete remission (CR): Participant must be free of all symptoms related to leukemia and have an absolute neutrophil count (ANC), 1.0 x 109/L, platelet count, 100 x 109/L, and normal bone marrow differential (5% blasts).

Complete remission without platelet recovery (CRp): As per CR but platelet count 100 x 109/L.

Complete Remission with Incomplete Blood Count Recovery (CRi): Peripheral blood and bone marrow results as for CR except for ANC \< 1.0 x 109/L with or without platelet count \< 100 x 109/L.

Partial remission (PR): CR with 6 to 25% abnormal cells in the marrow or 50% decrease in bone marrow blasts.

Morphologic leukemia-free state: Normal marrow differential (5% blasts); neutrophil and platelet counts are not considered.

Eli Lilly and Company

High Impact Clinical Research Support Program

M.D. Anderson Cancer Center

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Neoplasm Metastasis

Carcinoma

Lung Neoplasms

Small Cell Lung Carcinoma

Neoplasms, Glandular and Epithelial

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Carboplatin

Etoposide

Etoposide phosphate

LY2510924: 20 milligram (mg) administered once daily as a subcutaneous(SC) injection on days 1 to 7 of the 21 day cycle; repeat every 21 days for 6 cycles. Carboplatin: 5 milligram/millimeter/per minute (mg/mL/min) area under the curve (AUC) administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles.

Etoposide: 100 milligram square meter (mg/m\^2) administered intravenously on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles.

Carboplatin: 5 mg/mL/min area under the curve administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles.

Etoposide: 100 milligram square meter (mg/m\^2) administered on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

The purpose of this trial is to compare the progression free survival of LY2510924 + carboplatin + etoposide therapy versus carboplatin + etoposide therapy in participants with extensive-stage disease small cell lung cancer (SCLC)

A Study of LY2510924 in Participants With Extensive-Stage Small Cell Lung Carcinoma

A Randomized Phase 2 Study of LY2510924 and Carboplatin/Etoposide Versus Carboplatin/Etoposide in Extensive-Stage Small Cell Lung Carcinoma

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

PFS is defined as the time from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For participants who are still alive at the time of analysis and without evidence of tumor progression, PFS will be censored at the date of the most recent objective progression-free observation. For participants who receive subsequent anticancer therapy (except PCI) prior to objective disease progression or death, PFS will be censored at the date of the last objective progression-free observation prior to the date of subsequent therapy.

ORR is defined as the number of participants with a best response of CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.Tumor marker results must have normalized. PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression.

Overall survival (OS) is defined as the time from the randomization to the date of death from any cause. For participants who are still alive as of the data cutoff date, OS time will be censored on the date of the participant's last contact (last contact for participants in postdiscontinuation is last known alive date in mortality status).

DOR was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor marker results must have normalized. PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

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

LY2510924: 20 milligram (mg) administered once daily as a subcutaneous injection on days 1 to 7 of the 21 day cycle; repeat every 21 days for 6 cycles. Carboplatin: 5 milligram/millimeter/per minute (mg/mL/min) area under the curve (AUC) administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles. Etoposide: 100 milligram square meter (mg/m\^2) administered intravenously on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles.

LY2510924 + Carboplatin + Etoposide

Carboplatin: 5 mg/mL/min area under the curve administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles. Etoposide: 100 milligram square meter (mg/m\^2) administered on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles.

Carboplatin + Etoposide

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

All participants who received at least one dose of study.

Chief Medical Officer

All participants who received at least one dose of study drug. One participant was excluded from analysis due to protocol violation.The number of participants censored were LY2510924 + Carboplatin + Etoposide=13 and Carboplatin + Etoposide=7.

Progression Free Survival (PFS)

All participants who received at least one dose of study drug. One participant was excluded from analysis due to protocol violation.

Number of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR])

All participants who received at least one dose of study drug. One participant was excluded from analysis due to protocol violation. The numbers of participants censored were LY2510924 + Carboplatin + Etoposide= 4 and Carboplatin + Etoposide=3.

Overall Survival (OS)

All participants who received at least one dose of study drug. One participant was excluded from analysis due to protocol violation. The number of participants censored were LY2510924 + Carboplatin + Etoposide=47 and Carboplatin + Etoposide=42.

Duration of Overall Response (DOR)

Overall Study

Antibodies

Durvalumab

Immunoglobulins

Antineoplastic Agents, Immunological

20 milligrams (mg) LY2510924 given subcutaneously (SQ) once daily in combination with 1500 mg durvalumab given intravenously (IV) on Day 1 of each cycle (28 days).

30 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days).

40 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days).

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

The main purpose of this study is to evaluate the safety and tolerability of chemokine (C-X-C Motif) receptor 4 (CXCR4) peptide antagonist LY2510924 and durvalumab for phase 1a and 1b in participants with advanced refractory solid tumors.

A Study of LY2510924 and Durvalumab in Participants With Solid Tumors

A Phase 1a/1b Study of CXCR4 Peptide Antagonist (LY2510924) Administered in Combination With the Anti-PD-L1 Antibody, Durvalumab (MEDI4736), in Advanced Refractory Solid Tumors

DLT is defined as 1 of the following adverse events(AE) reported during the Phase 1a DLT observation period,if considered to be definitely,probably,or possibly related to either study regimen by the investigator;and fulfills any 1 of the following criterion using(NCI)CTCAE version(v)4.03:Grade4 immune-related AE,Grade4 non-laboratory AE,any CTCAE Grade ≥3 QT prolongation AE,≥Grade3 colitis or noninfectious pneumonitis irrespective of duration,Grade3 immune-related AE(excluding colitis,QT prolongation,or pneumonitis) that does not downgrade to Grade2 within 3 days after onset of event despite optimal medical management including systemic corticosteroids,or does not downgrade to ≤Grade 1 or baseline within 14 days,Grade2 pneumonitis that does not resolve to ≤Grade 1 within 3 days of the initiation of maximal supportive care,including corticosteroid therapy,Grade3 toxicity lasting an extended time despite optimal supportive care and there were also laboratory abnormalities criterion.

MTD was determined after the evaluation of Phase 1a portion of the trial. For Phase 1a, any DLT-equivalent toxicities observed in Cycle 2 and beyond were also be considered in dose escalation and determining MTD/recommended Phase 2 dose. See outcome measure number 1 for the DLT criterion.

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC \[0-∞\]) of LY2510924 when Co-Administered with Durvalumab

Number of participants with treatment-emergent positive Anti-Durvalumab antibodies was summarized by treatment group.

Best overall response of CR or PR was defined using RECIST v 1.1 criteria. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to \<10 mm, and normalization of tumor marker levels of non-target lesions. PR was defined as ≥30% decrease in sum of diameter(SOD) of target lesions taking as reference the baseline sum diameter. PD was defined as ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)\*100.

DCR: percentage of participants with CR, PR, or SD using RECIST v 1.1 criteria. CR: disappearance of all lesions, pathological lymph node reduction in short axis to \<10 mm, and normalization of tumor marker levels of non-target lesions. PR: ≥30% decrease in sum of diameter (SOD) of target lesions taking as reference baseline sum diameter. PD: ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference smallest sum of longest diameters recorded since treatment started and an absolute increase in sum diameter ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor increase to qualify for PD. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR+SD/total number of participants)\*100.

AstraZeneca

20 mg LY2510924 + 1500 mg Durvalumab

30 mg LY2510924 + 1500 mg Durvalumab

40 mg LY2510924 + 1500 mg Durvalumab

The study was terminated after the Phase 1a part was complete.

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

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

20 mg LY2510924 + 1500 mg Durvalumab:

20 milligrams (mg) LY2510924 given subcutaneously (SQ) once daily in combination with 1500 mg durvalumab given intravenously (IV) on Day 1 of each cycle (28 days).

30 mg LY2510924 + 1500 mg Durvalumab:

30 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days).

40 mg LY2510924 + 1500 mg Durvalumab:

40 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days).

All Phase 1a Participants

All phase 1a participants who received at least one dose of study drug.

Maximum Tolerated Dose (MTD) of LY2510924

Day 1

Day 15

20 milligrams (mg) LY2510924 given subcutaneously (SQ) in combination with 1500 mg durvalumab given intravenously (IV).

30 mg LY2510924 given SQ in combination with 1500 mg durvalumab given IV.

40 mg LY2510924 given SQ in combination with 1500 mg durvalumab given IV.

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC [0-∞]) of LY2510924 When Co-Administered With Durvalumab

Number of Participants With Anti-Durvalumab Antibodies When Administered in Combination With LY2510924

Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

Percentage of Participants With CR, PR, or Stable Disease (SD) (Disease Control Rate [DCR])

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma, Renal Cell

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

LY2510924: 20 milligram administered subcutaneously once daily, given every day of the 6 week cycle. Sunitinib: 50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.

50 milligram administered orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment. Treatment cycles will continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.

To compare the progression free survival of LY2510924 plus sunitinib therapy versus sunitinib in the first-line setting for patients with metastatic clear-cell renal cell carcinoma.

A Study of LY2510924 and Sunitinib in Patients With Metastatic Renal Cell Carcinoma

Randomized, Multicenter, Open-label, Active-Controlled, Phase 2 Study of LY2510924 and Sunitinib Versus Sunitinib in Patients With Metastatic Renal Cell Carcinoma

PFS is defined as the time from date of study Randomization to the first date of objectively determined progressive disease(PD) or death from any cause defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0).PD was defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study(including the baseline sum if that is the smallest).In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions was also considered PD.For participants still alive at the time of analysis and without evidence of tumor progression,PFS would be censored at the date of the most recent objective progression-free observation.For participants who receive subsequent anticancer therapy prior to objective disease progression or death,PFS was censored at the date of the last objective progression-free observation prior to the date of subsequent therapy.

ORR is defined as the number of participants with a best response of CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor marker results must have normalized. PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression.

OS is defined as the time from the date of study randomization to the date of death from any cause. For participants who were still alive as of the data cut-off date, OS time will be censored on the date of the participant's last contact (last contact for participants in post-discontinuation = last known alive date in mortality status).

Duration of complete response is defined as the time from the date when the measurement criteria are met for complete response until the date of first observation of objective disease progression (taking as reference for PD the smallest measurements recorded since the treatment started). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor marker results must have normalized. Progressive Disease (PD)is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

LY2510924 + Sunitinib

Study Terminated due to Insufficient Efficacy.

All participants who received at least one dose of study drug. Participants censored were LY2510924 + Sunitinib = 16 and Sunitinib=12.

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR])

All participants who received at least one dose of study drug. Participants censored were LY2510924 + Sunitinib=19 and Sunitinib=10.

All participants who received at least one dose of study drug. Participants censored were LY2510924 + Sunitinib=7 and Sunitinib=7.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
LY2510924, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia	NCT02652871	Leukemia	LY2510924 Idarubicin Cytarabine	18 Years - 70 Years	M.D. Anderson Cancer Center
A Study of LY2510924 in Participants With Extensive-Stage Small Cell Lung Carcinoma	NCT01439568	Extensive Stage...	LY2510924 Carboplatin Etoposide	18 Years -	Eli Lilly and Company
A Study of LY2510924 and Durvalumab in Participants With Solid Tumors	NCT02737072	Solid Tumor	LY2510924 Durvalumab	18 Years -	Eli Lilly and Company
A Study of LY2510924 and Durvalumab in Participants With Solid Tumors	NCT02737072	Solid Tumor	LY2510924 Durvalumab	18 Years -	Eli Lilly and Company
A Study of LY2510924 and Sunitinib in Patients With Metastatic Renal Cell Carcinoma	NCT01391130	Metastatic Clea...	LY2510924 Sunitinib	18 Years -	Eli Lilly and Company
LY2510924, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia	NCT02652871	Leukemia	LY2510924 Idarubicin Cytarabine	18 Years - 70 Years	M.D. Anderson Cancer Center
A Study of LY2510924 and Sunitinib in Patients With Metastatic Renal Cell Carcinoma	NCT01391130	Metastatic Clea...	LY2510924 Sunitinib	18 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for ly2510924

Every month we try and update this database with for ly2510924 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 ly2510924

Every month we try and update this database with for ly2510924 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 ly2510924 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.