Trial · NCT01059643
A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck
NCT01059643, Phase 2, Completed, Eli Lilly and Company; results first posted 2017-12-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck. Trials, record NCT01059643. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01059643
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck
- NCT number
- NCT01059643
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 103 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Ovarian Cancer, Non Small Cell Lung Cancer, Prostate Cancer, Colorectal Cancer, Gastric Cancer, Esophageal Cancer, Cancer of Head and Neck
- Interventions
- LY2523355, pegfilgrastim
- First posted
- 2010-02-01
- Last updated
- 2019-09-18
- Results first posted
- 2017-12-04
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | Baseline until progressive disease up to 36 weeks post-baseline | The percentage of participants who achieved a best response of either CR or PR, as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. 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. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. 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. Percentage is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100. |
| Secondary | Progression Free Survival (PFS) | Date of enrollment to progressive disease or death due to any cause up to 36 weeks post-enrollment | PFS defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 millimeter (mm) increase over nadir. For participants who were not known to have died or to have progressed as of the data inclusion cutoff date, PFS were censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy. |
| Secondary | Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) | Baseline until progressive disease up to 36 weeks post-baseline | Response using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria. 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. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. 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. SD was defined as small changes that did not meet above criteria. |
| Secondary | Tumor Marker Values as Relevant to Specific Tumor Types at Baseline | Baseline | The number of participants with colorectal cancer (CRC), gastroesophageal cancer (GE), non-small cell lung cancer (NSCLC), ovarian cancer, prostate cancer or squamous cell carcinoma of head and neck (SCCHN) who had marker/molecular diagnostics performed prior to study entry to determine the mutation status of cancer genes: APC, BRAF, BRCA1, BRCA2, HRAS and KRAS and the presence of Human Papillovirus (HPV) and Epstein Barr viruses (EBV). Mutation/virus status was defined as: positive (mutation/virus present), negative (mutation/virus not present), unknown (mutation/virus status unknown), or not done (mutation/virus status was not done). |
| Secondary | Change in Tumor Size at Smallest Size (Best Response) | Baseline until cycle with maximum change from baseline up to 36 weeks | The percent change in tumor size at its smallest size. The sum of diameters of target lesions was determined at each tumor assessment. The percent change is the smallest post-baseline sum divided by the baseline (pre-treatment) sum, multiplied by 100. |
| Secondary | Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 and Metabolite LSN2546307 | Day 3 of Cycle 1 (21-day cycle) | Plasma Cmax following daily doses of LY2523355 on Days 1, 2, and 3 of Cycle 1 (21-day cycle). |
| Secondary | Pharmacokinetics, Intracycle Accumulation Ratio (Ra) of LY2523355 | Day 1 and Day 3 of Cycle 1 (21-day cycle) | Intracycle Ra of LY2523355 is the ratio of LY2523355 maximum plasma concentration (Cmax) on Day 3 of Cycle 1 to the Cmax of LY2523355 on Day 1 of Cycle 1 following daily doses of LY2523355 on Days 1, 2 and 3 of Cycle 1 (21-day cycle) at each dose level. |
| Other | Number of Participants Who Died Due to Unknown Causes During the 30-Day Post-Study Treatment Follow-Up | End of study treatment up to 30-days post-study treatment discontinuation |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | Baseline until progressive disease up to 36 weeks post-baseline | All enrolled participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | Date of enrollment to progressive disease or death due to any cause up to 36 weeks post-enrollment | All enrolled participants who received at least 1 dose of study drug. Percentage (%) of participants censored were colorectal cancer 5.9%; gastroesophageal cancer 0.0%, non-small cell lung cancer 3.4%, ovarian cancer 15.4%, prostate cancer 16.7%, and squamous cell carcinoma of the head and neck 15.4%. | months | MEDIAN |
| SECONDARY | Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) | Baseline until progressive disease up to 36 weeks post-baseline | All enrolled participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Tumor Marker Values as Relevant to Specific Tumor Types at Baseline | Baseline | All enrolled participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Tumor Size at Smallest Size (Best Response) | Baseline until cycle with maximum change from baseline up to 36 weeks | All enrolled participants who received at least 1 dose of study drug with results at baseline and at time of best response. | percentage of change | MEAN |
| SECONDARY | Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 and Metabolite LSN2546307 | Day 3 of Cycle 1 (21-day cycle) | All enrolled participants who received at least 1 dose of study drug with Cmax measure. | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics, Intracycle Accumulation Ratio (Ra) of LY2523355 | Day 1 and Day 3 of Cycle 1 (21-day cycle) | All enrolled participants who received at least 1 dose of study drug with Ra measure. | ratio | GEOMETRIC_MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants Who Died Due to Unknown Causes During the 30-Day Post-Study Treatment Follow-Up | End of study treatment up to 30-days post-study treatment discontinuation | All enrolled participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group49
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | LY2523355 | Colorectal Cancer | 0 | 90% Confidence Interval 0.0 to 17.1 | percentage of participants |
| Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | LY2523355 | Gastroesophageal Cancer | 0 | 90% Confidence Interval 0.0 to 22.1 | percentage of participants |
| Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | LY2523355 | Non-Small Cell Lung Cancer | 0 | 90% Confidence Interval 0.0 to 10.9 | percentage of participants |
| Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | LY2523355 | Ovarian Cancer | 0 | 90% Confidence Interval 0.0 to 20.6 | percentage of participants |
| Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | LY2523355 | Prostate Cancer | 0 | 90% Confidence Interval 0.0 to 16.2 | percentage of participants |
| Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | LY2523355 | Squamous Cell Carcinoma of Head and Neck | 0 | 90% Confidence Interval 0.0 to 25.9 | percentage of participants |
| Progression Free Survival (PFS) | LY2523355 | Colorectal Cancer | 1.30 | 90% Confidence Interval 1.28 to 2.69 | months |
| Progression Free Survival (PFS) | LY2523355 | Gastroesophageal Cancer | 1.25 | 90% Confidence Interval 0.62 to 1.51 | months |
| Progression Free Survival (PFS) | LY2523355 | Non-Small Cell Lung Cancer | 1.31 | 90% Confidence Interval 1.28 to 1.91 | months |
| Progression Free Survival (PFS) | LY2523355 | Ovarian Cancer | 1.31 | 90% Confidence Interval 1.18 to 2.10 | months |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LY2523355 | 103 | |
| Overall Study | Received at Least 1 Dose of Study Drug | LY2523355 | 103 | |
| Overall Study | COMPLETED | LY2523355 | 97 | |
| Overall Study | NOT COMPLETED | LY2523355 | 6 |
Source ClinicalTrials.gov
Adverse events90
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 | LY2523355 | 33 | 103 | 52 |
| other | Neutropenia | Blood and lymphatic system disorders | LY2523355 | 21 | 103 | 21 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | LY2523355 | 13 | 103 | 18 |
| other | Abdominal pain | Gastrointestinal disorders | LY2523355 | 11 | 103 | 12 |
| other | Constipation | Gastrointestinal disorders | LY2523355 | 24 | 103 | 25 |
| other | Diarrhoea | Gastrointestinal disorders | LY2523355 | 18 | 103 | 22 |
| other | Dysphagia | Gastrointestinal disorders | LY2523355 | 6 | 103 | 6 |
| other | Nausea | Gastrointestinal disorders | LY2523355 | 35 | 103 | 38 |
| other | Oral pain | Gastrointestinal disorders | LY2523355 | 7 | 103 | 7 |
| other | Stomatitis | Gastrointestinal disorders | LY2523355 | 14 | 103 | 15 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LY2523355 | ||
| Total, other adverse events | LY2523355 | 102 | 103 |
| Total, serious adverse events | LY2523355 | 39 | 103 |
Source ClinicalTrials.gov
Papers0
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/NCT01059643
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