Trial · NCT01214629
A Study for Participants With Advanced Cancer
NCT01214629, Phase 1, Completed, Eli Lilly and Company; results first posted 2018-08-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study for Participants With Advanced Cancer. Trials, record NCT01214629. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01214629
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study for Participants With Advanced Cancer
- NCT number
- NCT01214629
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 54 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Advanced Cancer, Metastatic Cancer
- Interventions
- LY2523355, LY2523355, pegfilgrastim
- First posted
- 2010-10-05
- Last updated
- 2018-08-06
- Results first posted
- 2018-08-06
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended Dose for Phase 2 Studies | Baseline, daily up to 21 days in Cycle 1 | Recommended Phase 2 dose was determined by the maximum tolerated dose (MTD). The MTD was defined as the dose that caused \<1/3 of all participants treated with the study drug to experience a dose-limiting toxicity (DLT). A DLT was defined as an adverse event (AE) occurring during Cycle 1 that fulfilled 1 of the following criteria: Any Common Terminology Criteria for Adverse Events (CTCAE), version (v) 3.0 Grade ≥3 nonhematological toxicity possibly or likely related to the study drug (except for nausea/vomiting/diarrhea without maximal symptomatic/prophylactic treatment); any CTCAE v 3.0 Grade ≥3 thrombocytopenia with bleeding; any CTCAE v3.0 Grade 4 hematological toxicity of \>5 days duration; any febrile neutropenia. |
| Secondary | Number of Participants With Clinically Significant Effects | Baseline to study completion including 30-day follow-up up to 647 days,any AE reported | Adverse events (AEs) were considered clinically significant effects. Data presented are the number of participants who experienced serious AEs (SAEs), other non-serious AEs and deaths during the study, including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. |
| Secondary | Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2523355 Following A Single Dose | Cycle 1 Day 1(21-day cycle):End of infusion (EOI), Day 2: Predose, EOI, Day 3: Predose, EOI, between 1-2 hour EOI, Day 4: anytime, Day 8:anytime, Day 9: anytime, Day 10: anytime | Cmax following a single dose of LY2523355 at each dose level in the presence or absence of pegfilgrastim. |
| Secondary | Pharmacokinetics: Plasma Cmax of LY2523355 Following Multiple Doses | Cycle 1, Day 3(21-day cycle): End of infusion | Cmax following multiple doses of LY2523355 at each dose level in the presence or absence of pegfilgrastim. |
| Secondary | Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2523355 Following A Single Dose | Cycle 1,Day 1(21-day cycle): End of infusion (EOI), Day 2: Predose, EOI, Day 3: Predose, EOI, between 1-2 hour EOI, Day 4: anytime, Day 8:anytime, Day 9: anytime, Day 10: anytime | AUC(0-∞) following a single dose of LY2523355 at each dose level in the presence or absence of pegfilgrastim. |
| Secondary | Pharmacokinetics: AUC(0-∞) of LY2523355 Following Multiple Doses | Cycle 1, Day 3(21-day cycle): End of infusion | AUC(0-∞) following multiple doses of LY2523355 at each dose level in the presence or absence of pegfilgrastim. |
| Secondary | Number of Participants With Tumor Response | Baseline to measured disease progression or discontinuation up to 617 days | Data presented are the number of participants with a confirmed complete response (CR) or partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions. PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recommended Dose for Phase 2 Studies | Baseline, daily up to 21 days in Cycle 1 | All enrolled participants who received at least 1 dose of study drug. | mg/m²/day | NUMBER |
| SECONDARY | Number of Participants With Clinically Significant Effects | Baseline to study completion including 30-day follow-up up to 647 days,any AE reported | All enrolled participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2523355 Following A Single Dose | Cycle 1 Day 1(21-day cycle):End of infusion (EOI), Day 2: Predose, EOI, Day 3: Predose, EOI, between 1-2 hour EOI, Day 4: anytime, Day 8:anytime, Day 9: anytime, Day 10: anytime | All enrolled participants who received 1 dose of LY2523355 on Day 1 of Cycle 1 with evaluable pharmacokinetic data to enable determination of the LY2523355 plasma Cmax on Day 1 of Cycle 1. | nanograms/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics: Plasma Cmax of LY2523355 Following Multiple Doses | Cycle 1, Day 3(21-day cycle): End of infusion | All enrolled participants who received more than 1 dose of LY2523355 and had evaluable pharmacokinetic data to enable determination of the LY2523355 Cmax on Day 3 of Cycle 1. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2523355 Following A Single Dose | Cycle 1,Day 1(21-day cycle): End of infusion (EOI), Day 2: Predose, EOI, Day 3: Predose, EOI, between 1-2 hour EOI, Day 4: anytime, Day 8:anytime, Day 9: anytime, Day 10: anytime | All enrolled participants who received 1 dose of LY2523355 on Day 1 of Cycle 1 with evaluable pharmacokinetic data to enable calculation of the LY2523355 AUC(0-∞) on Day 1 of Cycle 1. | nanograms*hour/milliliter (ng*h/mL) | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics: AUC(0-∞) of LY2523355 Following Multiple Doses | Cycle 1, Day 3(21-day cycle): End of infusion | All enrolled participants who received more than 1 dose of LY2523355 and had evaluable pharmacokinetic data to enable calculation of the LY2523355 AUC(0-∞) on Day 3 of Cycle 1. | ng*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Tumor Response | Baseline to measured disease progression or discontinuation up to 617 days | All enrolled participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Recommended Dose for Phase 2 Studies | LY2523355 | 4.0 | mg/m²/day | ||
| Recommended Dose for Phase 2 Studies | LY2523355 + Pegfilgrastim | 6.0 | mg/m²/day | ||
| Number of Participants With Clinically Significant Effects | 0.125 mg/m²/Day LY | SAEs | 0 | Participants | |
| Number of Participants With Clinically Significant Effects | 0.25 mg/m²/Day LY | SAEs | 0 | Participants | |
| Number of Participants With Clinically Significant Effects | 0.5 mg/m²/Day LY | SAEs | 0 | Participants | |
| Number of Participants With Clinically Significant Effects | 1.0 mg/m²/Day LY | SAEs | 1 | Participants | |
| Number of Participants With Clinically Significant Effects | 2.0 mg/m²/Day LY | SAEs | 0 | Participants | |
| Number of Participants With Clinically Significant Effects | 4.0 mg/m²/Day LY | SAEs | 5 | Participants | |
| Number of Participants With Clinically Significant Effects | 5.0 mg/m²/Day LY | SAEs | 3 | Participants | |
| Number of Participants With Clinically Significant Effects | 6.0 mg/m²/Day LY | SAEs | 3 | Participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow44
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.125 mg/m²/Day LY | 1 | |
| Overall Study | STARTED | 0.25 mg/m²/Day LY | 1 | |
| Overall Study | STARTED | 0.5 mg/m²/Day LY | 1 | |
| Overall Study | STARTED | 1.0 mg/m²/Day LY | 3 | |
| Overall Study | STARTED | 2.0 mg/m²/Day LY | 3 | |
| Overall Study | STARTED | 4.0 mg/m²/Day LY | 13 | |
| Overall Study | STARTED | 5.0 mg/m²/Day LY | 5 | |
| Overall Study | STARTED | 6.0 mg/m²/Day LY | 3 | |
| Overall Study | STARTED | 4.0 mg/m²/Day LY + 6 mg PEG | 3 | |
| Overall Study | STARTED | 6.0 mg/m²/Day LY + 6 mg PEG | 18 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 participant flowAdverse events2,277
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 | 0.125 mg/m²/Day LY | 0 | 1 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 0.25 mg/m²/Day LY | 0 | 1 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 0.5 mg/m²/Day LY | 0 | 1 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 1.0 mg/m²/Day LY | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 2.0 mg/m²/Day LY | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 4.0 mg/m²/Day LY | 5 | 13 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | 4.0 mg/m²/Day LY + 6 mg PEG | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 5.0 mg/m²/Day LY | 2 | 5 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | 6.0 mg/m²/Day LY | 1 | 3 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | 6.0 mg/m²/Day LY + 6 mg PEG | 6 | 18 | 7 |
1 to 10 of 2,277Source ClinicalTrials.gov
See all 2,277 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.125 mg/m²/Day LY | ||
| Total, all-cause mortality | 0.25 mg/m²/Day LY | ||
| Total, all-cause mortality | 0.5 mg/m²/Day LY | ||
| Total, all-cause mortality | 1.0 mg/m²/Day LY | ||
| Total, all-cause mortality | 2.0 mg/m²/Day LY | ||
| Total, all-cause mortality | 4.0 mg/m²/Day LY | ||
| Total, all-cause mortality | 4.0 mg/m²/Day LY + 6 mg PEG | ||
| Total, all-cause mortality | 5.0 mg/m²/Day LY | ||
| Total, all-cause mortality | 6.0 mg/m²/Day LY | ||
| Total, all-cause mortality | 6.0 mg/m²/Day LY + 6 mg PEG |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01214629
GET https://conductscience.org/api/trials/v1/NCT01214629/results?page=2