Trial · NCT00721162
Study of Ramucirumab in Ovarian Cancer
NCT00721162, Phase 2, Completed, Eli Lilly and Company; results first posted 2014-06-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Ramucirumab in Ovarian Cancer. Trials, record NCT00721162. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00721162
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Ramucirumab in Ovarian Cancer
- NCT number
- NCT00721162
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- Interventions
- Ramucirumab
- First posted
- 2008-07-23
- Last updated
- 2019-09-26
- Other registries' IDs
- eudract:2007-006717-17
- Results first posted
- 2014-06-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Progression-Free Survival at 6 Months (PFS-6) | First Dose to 6 Months | Data presented are the percentage of participants without progressive disease (PD) or death from any cause at 6 month after first dose. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. |
| Primary | Objective Response Rate (ORR): Percentage of Participants With Complete Response (CR) and Partial Response (PR) | First dose to date of objective progressive disease /death or new anti-cancer therapy up to 34.6 months | Objective response is confirmed complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression/recurrence or the start of new therapeutic anticancer treatment, whichever occurred first, divided by the total number of participants treated, then multiplied by 100. |
| Secondary | Progression-Free Survival (PFS) | First dose to measured progressive disease or death due to any cause up to 34.6 months | Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment. |
| Secondary | Overall Survival at 1 Year (OS-1) | First dose to 12 months | Data presented are the percentage of participants surviving at least 12 months after first dose based on Kaplan Meier Method. |
| Secondary | Overall Survival (OS) | First dose to death due to any cause up to 43.9 months | Overall survival is defined as the time from first dose to the date of death due to any cause. For participants who were alive or were lost to follow-up, overall survival was censored on the last date the participant was known to be alive. |
| Secondary | Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events | First dose to 30 months | Data presented are the number of participants who experienced treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or 4 TEAE, or adverse events (AE) leading to discontinuation of treatment that were considered to be related to ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section. |
Source ClinicalTrials.gov
Outcomes6
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 Progression-Free Survival at 6 Months (PFS-6) | First Dose to 6 Months | All participants who received any amount of study drug. | percentage of participants | NUMBER |
| PRIMARY | Objective Response Rate (ORR): Percentage of Participants With Complete Response (CR) and Partial Response (PR) | First dose to date of objective progressive disease /death or new anti-cancer therapy up to 34.6 months | All participants who received any amount of study drug. | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | First dose to measured progressive disease or death due to any cause up to 34.6 months | All participants who received any amount of study drug. The number of participants censored was 11. | months | MEDIAN |
| SECONDARY | Overall Survival at 1 Year (OS-1) | First dose to 12 months | All participants who received any amount of study drug. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | First dose to death due to any cause up to 43.9 months | All participants who received any amount of study drug. The number of participants censored was 12. | months | MEDIAN |
| SECONDARY | Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events | First dose to 30 months | All participants who received any amount of study drug. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
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 Progression-Free Survival at 6 Months (PFS-6) | Ramucirumab | 25.0 | 95% Confidence Interval 14.7 to 37.9 | percentage of participants | |
| Objective Response Rate (ORR): Percentage of Participants With Complete Response (CR) and Partial Response (PR) | Ramucirumab | 5.0 | 95% Confidence Interval 1.0 to 13.9 | percentage of participants | |
| Progression-Free Survival (PFS) | Ramucirumab | 3.5 | 95% Confidence Interval 2.3 to 5.3 | months | |
| Overall Survival at 1 Year (OS-1) | Ramucirumab | 48.0 | 95% Confidence Interval 34.9 to 59.9 | percentage of participants | |
| Overall Survival (OS) | Ramucirumab | 11.1 | 95% Confidence Interval 8.3 to 17.0 | months | |
| Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events | Ramucirumab | Related TEAE | 56 | participants | |
| Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events | Ramucirumab | Related SAE | 10 | participants | |
| Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events | Ramucirumab | Related Grade 3 or 4 TEAE | 21 | participants | |
| Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events | Ramucirumab | Related AE leading to discontinuation | 4 | participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ramucirumab | 60 | |
| Overall Study | Received Any Amount of Study Drug | Ramucirumab | 60 | |
| Overall Study | COMPLETED | Ramucirumab | 60 | |
| Overall Study | NOT COMPLETED | Ramucirumab | 0 |
Source ClinicalTrials.gov
Adverse events79
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 | Ramucirumab | 11 | 60 | 21 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ramucirumab | 6 | 60 | 20 |
| other | Abdominal discomfort | Gastrointestinal disorders | Ramucirumab | 4 | 60 | 4 |
| other | Abdominal distension | Gastrointestinal disorders | Ramucirumab | 7 | 60 | 7 |
| other | Abdominal pain | Gastrointestinal disorders | Ramucirumab | 12 | 60 | 14 |
| other | Abdominal pain lower | Gastrointestinal disorders | Ramucirumab | 5 | 60 | 5 |
| other | Constipation | Gastrointestinal disorders | Ramucirumab | 13 | 60 | 15 |
| other | Diarrhoea | Gastrointestinal disorders | Ramucirumab | 21 | 60 | 41 |
| other | Dyspepsia | Gastrointestinal disorders | Ramucirumab | 6 | 60 | 8 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Ramucirumab | 4 | 60 | 4 |
1 to 10 of 79Source ClinicalTrials.gov
See all 79 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ramucirumab | ||
| Total, other adverse events | Ramucirumab | 58 | 60 |
| Total, serious adverse events | Ramucirumab | 22 | 60 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25016924 | DERIVED |
Source PubMed
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/NCT00721162
GET https://conductscience.org/api/trials/v1/NCT00721162/events?page=2