Trial · NCT01695005
A Study of LY3039478 in Participants With Advanced Cancer
NCT01695005, Phase 1, Completed, Eli Lilly and Company; results first posted 2025-12-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of LY3039478 in Participants With Advanced Cancer. Trials, record NCT01695005. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01695005
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of LY3039478 in Participants With Advanced Cancer
- NCT number
- NCT01695005
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 247 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Neoplasms, Neoplasm Metastasis, Lymphoma
- Interventions
- LY3039478, Prednisone
- First posted
- 2012-09-27
- Last updated
- 2025-12-26
- Results first posted
- 2025-12-26
- Limitations and caveats
1. There was no recommended phase II dose declared from Part F1 or F2. Expansion cohort was not triggered.~2. For outcome measure number 8 (Part A and B ((AUC \[0-∞\]) of LY3039478), AUC0-inf parameter cannot be calculated (per analysis plan) for Part B: 50 mg LY3039478 due to insufficient length of PK sampling to 8h for a drug half-life of around 5-6 hours.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A and F: Number of Participants With Dose Limiting Toxicities (DLTs) | Baseline through the end of Cycle 1, Up to 28 Days | DLT was defined as an adverse event (AE) during Cycle 1 (Up to 28 Days) that was related to LY3039478 and fulfilled any 1 of the following criterion using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE v 4.0): CTCAE Grade 3 non-hematological toxicity with a few exceptions, CTCAE Grade 4 hematological toxicity of greater than 5 days duration, any febrile neutropenia,Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia, Any other significant toxicity deemed by the primary investigator and Lilly clinical research personnel to be dose limiting (for example, any toxicity that is possibly related to the study medication that requires the withdrawal of the participant from the study during Cycle 1). |
| Primary | Part A: Recommended Phase 2 Dose of LY3039478 : Maximum Tolerated Dose (MTD) | Baseline though the end of cycle 1 (28 days cycle) | MTD is defined as the highest tested dose that has less than 33% probability of causing a DLT during Cycle 1. |
| Primary | Part B, C, D and E: Recommended Phase 2 Dose of LY3039478 : Maximum Tolerated Dose (MTD) | Baseline through the end of cycle 1 (28 days Cycle) | MTD is defined as the highest tested dose that has less than 33% probability of causing a DLT during Cycle 1. |
| Primary | Part F1 and F2: Recommended Phase 2 Dose of LY3039478 | Baseline Up to 2 Months | Parts F1 and F2 compared loading dose three time per week with prednisone versus two times per week with prednisone. Even though the trial may have found an MTD, it did not identify an Recommended Phase 2 dose (RP2D). |
| Primary | Part B, C, D, E and F: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | Baseline to Disease Progression or Participant Discontinuation (Up To 20 Months) | Objective response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST 1.1 ) guidelines. CR is disappearance of all target and non-target lesions; PR is greater than or equal to (\>=) 30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100. Analysis Population Description: Part D: 50 mg LY3039478 (Cohort 5) was assessed using Cheson criteria. Zero participants were analyzed for Part D: 50 mg LY3039478 (Cohort 4) because data were not collected. Data was not reported because both enrolled participants discontinued treatment early-one on Day 1 due to investigator decision and the other on Day 26 due to myocardial infarction, with no efficacy assessments performed. |
| Secondary | Parts A, B, C, D and E: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3039478 | Day 1: Predose,0.5,1,2,4,6-8,8-10,24-30 hours; Day 22: Predose, 0.5,1,2,4,6-8,8-10,24-30 hours | Parts A and B: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3039478 Analysis Population Description: Per Protocol, only sparse samples were analyzed for this outcome measure. There were no Sparse Day 22 samples for Part B: 50 mg \& 75 mg LY3039478, Part C: 50 mg \&75 LY3039478, Part D: 50 mg \& 75 LY3039478 and Part E: 50 mg LY3039478 |
| Secondary | Part F1 Cohort1 and Part F2 Cohort 1: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3039478 | Day 1: Predose,0.5,1,2,4,6-8,8-10,24-30 hours; Day 22: Predose, 0.5,1,2,4,6-8,8-10,24-30 hours | Part F1 Cohort 1 and Part F2 and Cohort 1: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3039478 |
| Secondary | Parts A and B: PK: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3039478 | Day 1: Predose,0.5,1,2,4,6-8,8-10,24-30 hours | PK: Area Under the Concentration-Time Curve From time 0 to Infinity (AUC\[0-∞\]) of LY3039478 Analysis Population Description: One participant assigned to the Part A: 45 mg group LY3039478 arm received 75 mg in error on Day 1 and had evaluable PK data. Therefore, this participant is included in the Part A: 75 mg LY3039478 arm PK analysis population (N=6), though only N=5 is shown in the Participant Flow module. |
| Secondary | Part F1 Cohort1 and Part F2 Cohort 1: PK: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3039478 | Day 1: Predose,0.5,1,2,4,6-8,8-10,24-30 hours | Part F1 Cohort1 and Part F2 Cohort 1: PK: Area Under the Concentration-Time Curve From time 0 to Infinity (AUC\[0-∞\]) of LY3039478 |
| Secondary | Parts A and B: PK: Area Under the Concentration-Time Curve From Time 0 to Tau (AUC[0-Tau]) of LY3039478 | Day 22: Predose,0.5,1,2,4,6-8,8-10,24-30 hours | PK: Area Under the Concentration-Time Curve From Time 0 to Tau (AUC\[0-Tau\]) of LY3039478 Analysis Population Description: Per protocol, AUC0-tau was not analyzed for participants undergoing sparse PK sampling. Part B 50mg participants only underwent sparse PK sampling. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A and F: Number of Participants With Dose Limiting Toxicities (DLTs) | Baseline through the end of Cycle 1, Up to 28 Days | All Part A and F participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Recommended Phase 2 Dose of LY3039478 : Maximum Tolerated Dose (MTD) | Baseline though the end of cycle 1 (28 days cycle) | All part A participants who received at least one dose of study drug. | milligram (mg) | NUMBER |
| PRIMARY | Part B, C, D and E: Recommended Phase 2 Dose of LY3039478 : Maximum Tolerated Dose (MTD) | Baseline through the end of cycle 1 (28 days Cycle) | All part B, C, D and E participants who received at least one dose of study drug. | milligram (mg) | NUMBER |
| PRIMARY | Part F1 and F2: Recommended Phase 2 Dose of LY3039478 | Baseline Up to 2 Months | All Part F1 and F2 participants who received at least one dose of study drug. | milligram (mg) | NUMBER |
| PRIMARY | Part B, C, D, E and F: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | Baseline to Disease Progression or Participant Discontinuation (Up To 20 Months) | All Part B, C, D, E and F participants who received at least one dose of study drug and who had evaluable responses. | percentage of participants | NUMBER |
| SECONDARY | Parts A, B, C, D and E: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3039478 | Day 1: Predose,0.5,1,2,4,6-8,8-10,24-30 hours; Day 22: Predose, 0.5,1,2,4,6-8,8-10,24-30 hours | All Participants who received at least one dose of study drug and had evaluable PK data from intensive PK sampling. One participant assigned to the Part A: 45 mg group LY3039478 arm received 75 mg in error on Day 1 and had evaluable PK data. Therefore, this participant is included in the Part A: 75 mg LY3039478 arm PK analysis population (N=6), though only 5 are shown in the Participant Flow module. | nanograms per millilitre (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Part F1 Cohort1 and Part F2 Cohort 1: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3039478 | Day 1: Predose,0.5,1,2,4,6-8,8-10,24-30 hours; Day 22: Predose, 0.5,1,2,4,6-8,8-10,24-30 hours | All participants who received at least one dose of study drug and had evaluable PK data from intensive PK sampling (Part F1 Cohort 1 and Part F2: Cohort 1 reporting Arms/Groups). No PK parameters are reported for participants who received loading doses of 100 (Part F1:Cohort2, Part F2:Cohort2 reporting arms) and 125mg (Part F2: Cohort3 reporting arm) on Day 1, because PK samples were not available for bioanalysis. | nanograms per millilitre (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Parts A and B: PK: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3039478 | Day 1: Predose,0.5,1,2,4,6-8,8-10,24-30 hours | All Participants who received at least one dose of study drug and had evaluable PK data from intensive PK sampling. No PK parameters are reported for participants who did not undergo intensive PK sampling (including Part B 50mg, some participants in Part B 75mg). | nanograms*hour per milliliter (ng*h/mL) | GEOMETRIC_MEAN |
| SECONDARY | Part F1 Cohort1 and Part F2 Cohort 1: PK: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3039478 | Day 1: Predose,0.5,1,2,4,6-8,8-10,24-30 hours | All participants who received at least one dose of study drug and had evaluable PK data from intensive PK sampling (Part F1 and Part F2). No PK parameters are reported for participants who received loading doses of 100 (Part F1:Cohort2, Part F2:Cohort2 reporting arms) and 125mg (Part F2: Cohort3 reporting arm) on Day 1, because PK samples were not available for bioanalysis. | nanograms*hour per milliliter (ng*h/mL) | GEOMETRIC_MEAN |
| SECONDARY | Parts A and B: PK: Area Under the Concentration-Time Curve From Time 0 to Tau (AUC[0-Tau]) of LY3039478 | Day 22: Predose,0.5,1,2,4,6-8,8-10,24-30 hours | All Participants who received at least one dose of study drug and had evaluable PK data from intensive PK sampling. Sampling was conducted in all Part A participants \& only a subset of participants in Part B at 75 mg. No PK parameters are reported for participants who did not undergo intensive PK sampling (including Part B 50mg, some participants in Part B 75mg). | nanograms*hour per milliliter (ng*h/mL) | GEOMETRIC_MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group167
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A and F: Number of Participants With Dose Limiting Toxicities (DLTs) | Part A: 2.5 mg LY3039478 | 0 | Participants | ||
| Part A and F: Number of Participants With Dose Limiting Toxicities (DLTs) | Part A: 5 mg LY3039478 | 0 | Participants | ||
| Part A and F: Number of Participants With Dose Limiting Toxicities (DLTs) | Part A: 10 mg LY3039478 | 0 | Participants | ||
| Part A and F: Number of Participants With Dose Limiting Toxicities (DLTs) | Part A: 20 mg LY3039478 | 1 | Participants | ||
| Part A and F: Number of Participants With Dose Limiting Toxicities (DLTs) | Part A: 30 mg LY3039478 | 1 | Participants | ||
| Part A and F: Number of Participants With Dose Limiting Toxicities (DLTs) | Part A: 45 mg LY3039478 | 0 | Participants | ||
| Part A and F: Number of Participants With Dose Limiting Toxicities (DLTs) | Part A: 60 mg LY3039478 | 2 | Participants | ||
| Part A and F: Number of Participants With Dose Limiting Toxicities (DLTs) | Part A: 75 mg LY3039478 | 0 | Participants | ||
| Part A and F: Number of Participants With Dose Limiting Toxicities (DLTs) | Part A: 100 mg LY3039478 | 2 | Participants | ||
| Part A and F: Number of Participants With Dose Limiting Toxicities (DLTs) | Part F1:Cohort1 Load75mg_50mg LY3039478 + Prednisone | 1 | Participants |
1 to 10 of 167Source ClinicalTrials.gov
See all 167 results by groupParticipant flow116
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: 2.5 mg LY3039478 | 4 | |
| Overall Study | STARTED | Part A: 5 mg LY3039478 | 3 | |
| Overall Study | STARTED | Part A: 10 mg LY3039478 | 4 | |
| Overall Study | STARTED | Part A: 20 mg LY3039478 | 8 | |
| Overall Study | STARTED | Part A: 30 mg LY3039478 | 7 | |
| Overall Study | STARTED | Part A: 45 mg LY3039478 | 5 | |
| Overall Study | STARTED | Part A: 60 mg LY3039478 | 9 | |
| Overall Study | STARTED | Part A: 75 mg LY3039478 | 5 | |
| Overall Study | STARTED | Part A: 100 mg LY3039478 | 10 | |
| Overall Study | STARTED | Part B: 50 mg LY3039478 | 30 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 participant flowAdverse events12,992
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Part A: 2.5 mg LY3039478 | 1 | 4 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: 5 mg LY3039478 | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: 10 mg LY3039478 | 1 | 4 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: 20 mg LY3039478 | 1 | 8 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: 30 mg LY3039478 | 0 | 7 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: 45 mg LY3039478 | 3 | 5 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: 60 mg LY3039478 | 1 | 9 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: 75 mg LY3039478 | 0 | 5 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: 100 mg LY3039478 | 2 | 10 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Part B: 75 mg LY3039478 | 6 | 25 | 12 |
1 to 10 of 12,992Source ClinicalTrials.gov
See all 12,992 adverse eventsAdverse event totals87
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: 2.5 mg LY3039478 | 1 | 4 |
| Total, all-cause mortality | Part A: 5 mg LY3039478 | 0 | 3 |
| Total, all-cause mortality | Part A: 10 mg LY3039478 | 2 | 4 |
| Total, all-cause mortality | Part A: 20 mg LY3039478 | 1 | 8 |
| Total, all-cause mortality | Part A: 30 mg LY3039478 | 1 | 7 |
| Total, all-cause mortality | Part A: 45 mg LY3039478 | 2 | 5 |
| Total, all-cause mortality | Part A: 60 mg LY3039478 | 4 | 9 |
| Total, all-cause mortality | Part A: 75 mg LY3039478 | 3 | 5 |
| Total, all-cause mortality | Part A: 100 mg LY3039478 | 4 | 10 |
| Total, all-cause mortality | Part B: 75 mg LY3039478 | 16 | 25 |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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