Trial · NCT00318370
Effectiveness of MORAb-003 in Women With Ovarian Cancer Who Have Relapsed After Platinum-Based Chemotherapy
NCT00318370, Phase 2, Completed, Morphotek; results first posted 2012-02-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effectiveness of MORAb-003 in Women With Ovarian Cancer Who Have Relapsed After Platinum-Based Chemotherapy. Trials, record NCT00318370. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00318370
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness of MORAb-003 in Women With Ovarian Cancer Who Have Relapsed After Platinum-Based Chemotherapy
- NCT number
- NCT00318370
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 58 participants, actual
- Lead sponsor
- Morphotek
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms
- Interventions
- Farletuzumab, Chemo Plus Far
- First posted
- 2006-04-26
- Last updated
- 2015-09-09
- Results first posted
- 2012-02-15
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Serologic Response (Change in CA125 Level) | Baseline to response (up to 30 weeks) | Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who achieved a 50% response = \>50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L). |
| Primary | Serologic Response (Change in Cancer Antigen [CA-125] Level) | Baseline to response (up to 27 weeks) | Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who had a 50% response = \>50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L). |
| Secondary | Time to Serologic Response (Change in CA-125 Level) | Baseline to response (up to 27 weeks) | Time to Serologic Response is defined as the time (weeks) from the date of first farletuzumab infusion to first documentation of 50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and at least twice the upper limit of normal) and then confirmed after 21 days. |
| Secondary | Duration of Serologic Response (CA-125) | Baseline to response (up to 44 months) | Calculated as the time from the first documentation of 50% or greater reduction in CA-125 to the first documentation of serologic progression or death due to any cause. Serologic progression was defined as the first date of the CA-125 level being \>2 X ULN on two occasions. |
| Secondary | Overall Response Rate | Baseline to response (up to 44 months) | The Overall Response Rate (ORR) will be determined by applying standard RECIST criteria to objective measures of disease, such as CT or MRI scans. Participants will be assigned to one of the categories of change in disease status, namely, "complete response" (CR), "partial response" (PR), "stable disease" (SD), or "progressive disease" (PD). ORR is defined as the percentage of participants with objective evidence of CR or PR. |
| Secondary | Progression-free Survival (PFS) | Baseline to response (up to 44 months) | PFS is defined for participants treated in Chemo Plus Far as the time (in months) from date of first dose in Chemo Plus Far until date of the first observation of progression based on first date of the CA-125 \>2 X ULN on two occasions, or date of death, whatever the cause. If progression or death is not observed for a participant, the PFS time is censored at the later date of last tumor assessment or CA125 assessment without evidence of progression prior to the date of initiation of further anti-tumor treatment. |
| Secondary | Percentage of Participants Who Had a Prolongation of Remission | Baseline to response (up to 44 months) | Percentage of participants whose second remission was longer than their first remission. The length of remission will be determined for participants who attain CR or PR (or SD and investigator's assessment of clinical benefit). Prolongation of remission will be defined as a length of remission occurring on this study that is ≥ 1 day longer than the length of remission to the original therapy. The length of remission on this study (second remission) will be defined as the amount of time from the date of first CR or PR to the end of this remission. |
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 | Serologic Response (Change in CA125 Level) | Baseline to response (up to 30 weeks) | All participants enrolled to initial farletuzumab only. | participants | NUMBER |
| PRIMARY | Serologic Response (Change in Cancer Antigen [CA-125] Level) | Baseline to response (up to 27 weeks) | All participants enrolled to chemotherapy plus farletuzumab. | participants | NUMBER |
| SECONDARY | Time to Serologic Response (Change in CA-125 Level) | Baseline to response (up to 27 weeks) | All participants enrolled to intial chemotherapy plus farletuzumab. | Weeks | MEDIAN |
| SECONDARY | Duration of Serologic Response (CA-125) | Baseline to response (up to 44 months) | All participants enrolled to initial chemotherapy plus farletuzumab. | Months | MEDIAN |
| SECONDARY | Overall Response Rate | Baseline to response (up to 44 months) | percentage of participants | NUMBER | |
| SECONDARY | Progression-free Survival (PFS) | Baseline to response (up to 44 months) | All participants who received chemotherapy plus farletuzumab as well as those who continued on maintenance farletuzumab. | Months | MEDIAN |
| SECONDARY | Percentage of Participants Who Had a Prolongation of Remission | Baseline to response (up to 44 months) | All participants who received chemotherapy plus farletuzumab as well as those who continued on maintenance farletuzumab. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Serologic Response (Change in CA125 Level) | Far Only | 2 | 95% Confidence Interval 0.9 to 23.5 | participants | |
| Serologic Response (Change in Cancer Antigen [CA-125] Level) | Chemo Plus Far | 41 | 74.3 to 95.2 | participants | |
| Time to Serologic Response (Change in CA-125 Level) | Chemo Plus Far | 3.3 | 95% Confidence Interval 3.1 to 6.1 | Weeks | |
| Duration of Serologic Response (CA-125) | Chemo Plus Far | NA | 95% Confidence Interval 9.9 to NA | Months | |
| Overall Response Rate | Chemo Plus Far | Complete Response | 6.8 | percentage of participants | |
| Overall Response Rate | Chemo Plus Far | Partial Response | 63.6 | percentage of participants | |
| Overall Response Rate | Chemo Plus Far | Stable Disease | 20.5 | percentage of participants | |
| Overall Response Rate | Chemo Plus Far | Progressive Disease | 4.5 | percentage of participants | |
| Overall Response Rate | Chemo Plus Far | Not Evaluable | 6.8 | percentage of participants | |
| Progression-free Survival (PFS) | Chemo Plus Far Plus Maintenance Far Only | 10.2 | 95% Confidence Interval 7.4 to 13.1 | Months |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Far Only | 28 | |
| Period 1 | STARTED | Chemo Plus Far | 0 | |
| Period 1 | STARTED | Maintenance Far Only | 0 | |
| Period 1 | COMPLETED | Far Only | 21 | |
| Period 1 | COMPLETED | Chemo Plus Far | 0 | |
| Period 1 | COMPLETED | Maintenance Far Only | 0 | |
| Period 1 | NOT COMPLETED | Far Only | 7 | |
| Period 1 | NOT COMPLETED | Chemo Plus Far | 0 | |
| Period 1 | NOT COMPLETED | Maintenance Far Only | 0 | |
| Period 2 | STARTED | Far Only | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events148
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 | Nausea | Gastrointestinal disorders | Far Only and Chemo Plus Far and Maintenance Far Only | 35 | 54 | |
| other | Constipation | Gastrointestinal disorders | Far Only and Chemo Plus Far and Maintenance Far Only | 33 | 54 | |
| other | Diarrhoea | Gastrointestinal disorders | Far Only and Chemo Plus Far and Maintenance Far Only | 26 | 54 | |
| other | Vomiting | Gastrointestinal disorders | Far Only and Chemo Plus Far and Maintenance Far Only | 25 | 54 | |
| other | Abdominal Pain | Gastrointestinal disorders | Far Only and Chemo Plus Far and Maintenance Far Only | 24 | 54 | |
| other | Abdominal distension | Gastrointestinal disorders | Far Only and Chemo Plus Far and Maintenance Far Only | 13 | 54 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Far Only and Chemo Plus Far and Maintenance Far Only | 8 | 54 | |
| other | Dyspepsia | Gastrointestinal disorders | Far Only and Chemo Plus Far and Maintenance Far Only | 8 | 54 | |
| other | Oral pain | Gastrointestinal disorders | Far Only and Chemo Plus Far and Maintenance Far Only | 7 | 54 | |
| other | Ascites | Gastrointestinal disorders | Far Only and Chemo Plus Far and Maintenance Far Only | 5 | 54 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Far Only and Chemo Plus Far and Maintenance Far Only | ||
| Total, other adverse events | Far Only and Chemo Plus Far and Maintenance Far Only | 54 | 54 |
| Total, serious adverse events | Far Only and Chemo Plus Far and Maintenance Far Only | 20 | 54 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23474348 | 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/NCT00318370
GET https://conductscience.org/api/trials/v1/NCT00318370/flow?page=2