Trial · NCT01214642
A Dose-Escalation Study for Patients With Advanced Cancer
NCT01214642, 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 Dose-Escalation Study for Patients With Advanced Cancer. Trials, record NCT01214642. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01214642
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose-Escalation Study for Patients With Advanced Cancer
- NCT number
- NCT01214642
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 63 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Advanced Cancer
- Interventions
- pegfilgrastim, LY2523355
- 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 and Schedule for Phase 2 Studies | Cycle 1 (21 days): Day 1, 5 and 9, any AE reported | The recommended dose and schedule for Phase 2 studies is defined as the maximum tolerated dose (MTD). MTD is defined as the dose level at which no more than 2 dose limiting toxicities (DLTs), no more than 3 dose reductions (DR) or dose omissions (DO) and no more than 1 DLT plus 2 DR/DO occurred. DLT is defined as an adverse event (AE) occurring in Cycle 1 with the following criteria according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0: Any ≥Grade 3 nonhematological toxicity (except nausea/vomiting or diarrhea controlled with treatment or fatigue); ≥Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia with bleeding; Grade 4 hematological toxicity of \>5 days duration, excluding thrombocytopenia; febrile neutropenia. |
| Secondary | Number of Participants With Clinically Significant Effects | Baseline to Cycle 38 (21-day cycles): daily for AEs | Clinically significant effects were defined as serious and other non-serious adverse events (AEs). A summary of serious and other non-serious AEs is located in the Reported Adverse Events module. |
| Secondary | Pharmacokinetics Maximum Concentration (Cmax), Single Dose | Cycle 1 Day 1 of 21-day cycle: Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose | Plasma Cmax following a single dose of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG). |
| Secondary | Pharmacokinetics Maximum Concentration (Cmax), Multiple Dose | Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose | Plasma Cmax following multiple doses of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG). |
| Secondary | Pharmacokinetics Area Under the Concentration-time Curve (AUC), Single Dose | Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose | Plasma AUC from time zero to infinity \[AUC(0-∞)\] and AUC from time zero to 24 hours post-dose \[AUC(0-24)\] following a single dose of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG). |
| Secondary | Pharmacokinetic Areas Under the Concentration Time Curve (AUC), Multiple Dose | Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose | Plasma AUC from time zero to infinity (0-∞) and AUC from time zero to 24 hours (0-24) post-dose following multiple doses of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG). |
| Secondary | Number of Participants With Tumor Response | Baseline to measured disease progression or discontinuation up to Cycle 38 (21-day cycles) | Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria and the Revised International Working Group (IWG) lymphoma response criteria for lymphoma patients. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. Tumor response is CR + PR. |
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 and Schedule for Phase 2 Studies | Cycle 1 (21 days): Day 1, 5 and 9, any AE reported | All participants who received at least 1 dose of LY2523355. | mg/m^2/day | NUMBER |
| SECONDARY | Number of Participants With Clinically Significant Effects | Baseline to Cycle 38 (21-day cycles): daily for AEs | All participants who had at least 1 dose of LY2523355. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetics Maximum Concentration (Cmax), Single Dose | Cycle 1 Day 1 of 21-day cycle: Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose | All participants who received 1 dose of LY2523355 and had Cmax samples collected on Day 1 of Cycle 1. | nanograms/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics Maximum Concentration (Cmax), Multiple Dose | Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose | All participants who received 2 doses of study drug and had a Cmax sample collected on Days 4, 5, 8 or 9 of Cycle 1 (based on schedule of administration) after multiple dose administration of LY2523355. | nanograms/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics Area Under the Concentration-time Curve (AUC), Single Dose | Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose | All participants who received 1 dose of LY2523355 and had pharmacokinetic samples collected on Day 1 of Cycle 1 to enable calculation of AUC(0-∞) and AUC(0-24). | nanograms*hour/milliter (ng*hr/mL) | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetic Areas Under the Concentration Time Curve (AUC), Multiple Dose | Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose | All participants who received 2 doses of study drug and had pharmacokinetic samples collected on Day 4, 5, 8, or 9 of Cycle 1 (based on schedule of administration) to enable calculation of AUC(0-∞) and AUC(0-24) after multiple dose administration of LY2523355. | nanograms*hour/milliliter (ng*hr/mL) | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Tumor Response | Baseline to measured disease progression or discontinuation up to Cycle 38 (21-day cycles) | All participants who received 1 dose of LY2523355. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group85
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Recommended Dose and Schedule for Phase 2 Studies | LY2523355 / LY2523355 +PEG | 8 | mg/m^2/day | ||
| Number of Participants With Clinically Significant Effects | Part A - Days 1, 5, 9 - 2 mg/m^2/Day | Serious AEs | 1 | Participants | |
| Number of Participants With Clinically Significant Effects | Part A - Days 1, 5, 9 - 4 mg/m^2/Day | Serious AEs | 2 | Participants | |
| Number of Participants With Clinically Significant Effects | Part A - Days 1, 5, 9 - 8 mg/m^2/Day | Serious AEs | 2 | Participants | |
| Number of Participants With Clinically Significant Effects | Part A - Days 1, 5, 9 - 7 mg/m^2/Day | Serious AEs | 2 | Participants | |
| Number of Participants With Clinically Significant Effects | Part A - Days 1, 5, 9 - 6 mg/m^2/Day | Serious AEs | 1 | Participants | |
| Number of Participants With Clinically Significant Effects | Part A - Days 1, 5, 9 - 5 mg/m^2/Day | Serious AEs | 0 | Participants | |
| Number of Participants With Clinically Significant Effects | Part A - Days 1, 8 - 8 mg/m^2/Day | Serious AEs | 1 | Participants | |
| Number of Participants With Clinically Significant Effects | Part A - Days 1, 5+PEG - 8 mg/m2/Day | Serious AEs | 0 | Participants | |
| Number of Participants With Clinically Significant Effects | Part A - Days 1, 5+PEG - 12 mg/m^2/Day | Serious AEs | 0 | Participants |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A - Days 1, 5, 9 - 2 mg/m^2/Day | 3 | |
| Overall Study | STARTED | Part A - Days 1, 5, 9 - 4 mg/m^2/Day | 3 | |
| Overall Study | STARTED | Part A - Days 1, 5, 9 - 8 mg/m^2/Day | 6 | |
| Overall Study | STARTED | Part A - Days 1, 5, 9 - 7 mg/m^2/Day | 6 | |
| Overall Study | STARTED | Part A - Days 1, 5, 9 - 6 mg/m^2/Day | 6 | |
| Overall Study | STARTED | Part A - Days 1, 5, 9 - 5 mg/m^2/Day | 3 | |
| Overall Study | STARTED | Part A - Days 1, 8 - 8 mg/m^2/Day | 6 | |
| Overall Study | STARTED | Part A - Days 1, 5+PEG - 8 mg/m^2/Day | 3 | |
| Overall Study | STARTED | Part A and B- Days 1, 5+PEG - 12 mg/m^2/Day | 13 | |
| Overall Study | STARTED | Part A - Days 1, 5+PEG - 16 mg/m^2/Day | 4 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events2,574
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 - Days 1, 5, 9 - 2 mg/m^2/Day | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part A - Days 1, 5, 9 - 4 mg/m^2/Day | 1 | 3 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Part A - Days 1, 5, 9 - 8 mg/m^2/Day | 1 | 6 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Part A - Days 1, 5, 9 - 7 mg/m^2/Day | 1 | 6 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Part A - Days 1, 5, 9 - 6 mg/m^2/Day | 2 | 6 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Part A - Days 1, 5, 9 - 5 mg/m^2/Day | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part A - Days 1, 8 - 8 mg/m^2/Day | 0 | 6 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part A - Days 1, 5+PEG - 8 mg/m^2/Day | 2 | 3 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Part A - Days 1, 5+PEG - 12 mg/m^2/Day | 2 | 3 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Part A - Days 1, 5+PEG - 16 mg/m^2/Day | 1 | 4 | 1 |
1 to 10 of 2,574Source ClinicalTrials.gov
See all 2,574 adverse eventsAdverse event totals39
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A - Days 1, 5, 9 - 2 mg/m^2/Day | ||
| Total, all-cause mortality | Part A - Days 1, 5, 9 - 4 mg/m^2/Day | ||
| Total, all-cause mortality | Part A - Days 1, 5, 9 - 8 mg/m^2/Day | ||
| Total, all-cause mortality | Part A - Days 1, 5, 9 - 7 mg/m^2/Day | ||
| Total, all-cause mortality | Part A - Days 1, 5, 9 - 6 mg/m^2/Day | ||
| Total, all-cause mortality | Part A - Days 1, 5, 9 - 5 mg/m^2/Day | ||
| Total, all-cause mortality | Part A - Days 1, 8 - 8 mg/m^2/Day | ||
| Total, all-cause mortality | Part A - Days 1, 5+PEG - 8 mg/m^2/Day | ||
| Total, all-cause mortality | Part A - Days 1, 5+PEG - 12 mg/m^2/Day | ||
| Total, all-cause mortality | Part A - Days 1, 5+PEG - 16 mg/m^2/Day |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 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.
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