Trial · NCT00738699
An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer
NCT00738699, Phase 2, Terminated, Morphotek; results first posted 2017-03-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer. Trials, record NCT00738699. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00738699
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer
- NCT number
- NCT00738699
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 415 participants, actual
- Lead sponsor
- Morphotek
- Conditions
- Ovarian Cancer
- Interventions
- MORAb-003 (farletuzumab), 0.9% Saline, Paclitaxel
- First posted
- 2008-08-20
- Last updated
- 2017-03-30
- Results first posted
- 2017-03-30
- Limitations and caveats
- This study was prematurely terminated by the sponsor following results of the preplanned futility analysis showing the study was unlikely to meet its statistically-defined coprimary endpoints.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | Date of Randomization to date of disease progression or death (whichever came first), assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months | PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression as determined by modified Response Evaluation Criteria in Solid Tumors (RECIST), or death regardless of cause. If progression or death was not observed, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier). |
| Primary | Overall Survival (OS) | Date of Randomization to date of death, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months | OS was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier. |
| Secondary | Best Overall Response | Date of first study drug to disease progression/recurrence, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months | BOR was defined as the percentage of participants having either a confirmed complete response (CR) or confirmed partial response (PR) using modified RECIST criteria by independent radiologist review. RECIST criteria was adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Tumor assessments performed up to the initiation of further antitumor treatment were considered. Target lesions selected for response assessment were measured using computed tomography (CT) or magnetic resonance imaging (MRI) scans then graded according to the modified RECIST criteria, adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Participants were assigned to one of the categories of change in disease state; CR, PR, progressive disease (PD), stable disease ( S)D, or not evaluable (NE). |
| Secondary | Time to Tumor Response (TTR) | Date of Randomization to the first documentation of objective TR, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months | TTR was derived for those participants with objective evidence of CR or PR, and was defined as the time (in months) from the date of randomization to the first documentation of object tumor response (TR). Analysis was based on the Kaplan-Meier estimated percentage of responders. This statistical analysis method measures the effect of study drug on tumor response over a period of time. |
| Other | Progression Free Survival Based on Gynecologic Cancer InterGroup (GCIG) | Length of study | Due to termination of the study, data were not collected and the outcome measure for PFS based on GCIG was not analyzed. |
| Other | Serologic Response Rate | Length of study | Due to termination of the study, data were not collected and the outcome measure for Serologic Response Rate was not analyzed. |
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 | Progression-Free Survival (PFS) | Date of Randomization to date of disease progression or death (whichever came first), assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months | Intent-To-Treat (ITT) population included all participants who were randomly assigned to study drug, analyzed by treatment assignment. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) | Date of Randomization to date of death, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months | ITT population included all participants who were randomly assigned to study drug and analyzed by the treatment assigned. | Months | MEDIAN |
| SECONDARY | Best Overall Response | Date of first study drug to disease progression/recurrence, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months | ITT population included all participants who were randomly assigned to study drug and analyzed by the treatment assigned. | Percentage of participants | NUMBER |
| SECONDARY | Time to Tumor Response (TTR) | Date of Randomization to the first documentation of objective TR, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months | ITT population (Responders only) included all participants who were randomly assigned to study drug and analyzed by the treatment assigned. | Months | MEDIAN |
| OTHER_PRE_SPECIFIED | Progression Free Survival Based on Gynecologic Cancer InterGroup (GCIG) | Length of study | Due to termination of the study, data were not collected and the outcome measure for PFS based on GCIG was not analyzed. | ||
| OTHER_PRE_SPECIFIED | Serologic Response Rate | Length of study | Due to termination of the study, data were not collected and the outcome measure for Serologic Response Rate was not analyzed. |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | MORAb-003 (Farletuzumab) Plus Paclitaxel | 3.5 | 95% Confidence Interval 3.3 to 3.9 | Months | |
| Progression-Free Survival (PFS) | Placebo (Normal Saline) Plus Paclitaxel | 3.7 | 95% Confidence Interval 3.3 to 5.2 | Months | |
| Overall Survival (OS) | MORAb-003 (Farletuzumab) Plus Paclitaxel | 11.3 | 95% Confidence Interval 10.3 to 12.7 | Months | |
| Overall Survival (OS) | Placebo (Normal Saline) Plus Paclitaxel | 13.1 | 95% Confidence Interval 10.3 to 16.7 | Months | |
| Best Overall Response | MORAb-003 (Farletuzumab) Plus Paclitaxel | Complete response (CR) | 0.4 | Percentage of participants | |
| Best Overall Response | Placebo (Normal Saline) Plus Paclitaxel | Complete response (CR) | 0 | Percentage of participants | |
| Best Overall Response | MORAb-003 (Farletuzumab) Plus Paclitaxel | Partial response (PR) | 7.3 | Percentage of participants | |
| Best Overall Response | Placebo (Normal Saline) Plus Paclitaxel | Partial response (PR) | 15.0 | Percentage of participants | |
| Time to Tumor Response (TTR) | MORAb-003 (Farletuzumab) Plus Paclitaxel | 2.0 | 95% Confidence Interval 1.6 to 3.5 | Months | |
| Time to Tumor Response (TTR) | Placebo (Normal Saline) Plus Paclitaxel | 1.7 | 95% Confidence Interval 1.6 to 3.3 | Months |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MORAb-003 (Farletuzumab) Plus Paclitaxel | 275 | |
| Overall Study | STARTED | Placebo (Normal Saline) Plus Paclitaxel | 140 | |
| Overall Study | Participants Not Treated | MORAb-003 (Farletuzumab) Plus Paclitaxel | 2 | |
| Overall Study | Participants Not Treated | Placebo (Normal Saline) Plus Paclitaxel | 1 | |
| Overall Study | Participants Treated | MORAb-003 (Farletuzumab) Plus Paclitaxel | 273 | |
| Overall Study | Participants Treated | Placebo (Normal Saline) Plus Paclitaxel | 139 | |
| Overall Study | COMPLETED | MORAb-003 (Farletuzumab) Plus Paclitaxel | 0 | |
| Overall Study | COMPLETED | Placebo (Normal Saline) Plus Paclitaxel | 0 | |
| Overall Study | NOT COMPLETED | MORAb-003 (Farletuzumab) Plus Paclitaxel | 275 | |
| Overall Study | NOT COMPLETED | Placebo (Normal Saline) Plus Paclitaxel | 140 |
Source ClinicalTrials.gov
Adverse events412
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 | MORAb-003 (Farletuzumab) Plus Paclitaxel | 132 | 279 | |
| other | Nausea | Gastrointestinal disorders | Placebo (Normal Saline) Plus Paclitaxel | 66 | 133 | |
| other | Diarrhoea | Gastrointestinal disorders | MORAb-003 (Farletuzumab) Plus Paclitaxel | 119 | 279 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo (Normal Saline) Plus Paclitaxel | 53 | 133 | |
| other | Constipation | Gastrointestinal disorders | MORAb-003 (Farletuzumab) Plus Paclitaxel | 96 | 279 | |
| other | Constipation | Gastrointestinal disorders | Placebo (Normal Saline) Plus Paclitaxel | 53 | 133 | |
| other | Abdominal pain | Gastrointestinal disorders | MORAb-003 (Farletuzumab) Plus Paclitaxel | 88 | 279 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo (Normal Saline) Plus Paclitaxel | 34 | 133 | |
| other | Vomiting | Gastrointestinal disorders | MORAb-003 (Farletuzumab) Plus Paclitaxel | 84 | 279 | |
| other | Vomiting | Gastrointestinal disorders | Placebo (Normal Saline) Plus Paclitaxel | 37 | 133 |
1 to 10 of 412Source ClinicalTrials.gov
See all 412 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MORAb-003 (Farletuzumab) Plus Paclitaxel | ||
| Total, all-cause mortality | Placebo (Normal Saline) Plus Paclitaxel | ||
| Total, other adverse events | MORAb-003 (Farletuzumab) Plus Paclitaxel | 278 | 279 |
| Total, other adverse events | Placebo (Normal Saline) Plus Paclitaxel | 133 | 133 |
| Total, serious adverse events | MORAb-003 (Farletuzumab) Plus Paclitaxel | 127 | 279 |
| Total, serious adverse events | Placebo (Normal Saline) Plus Paclitaxel | 55 | 133 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| MORAb-003 (Farletuzumab) Plus Paclitaxel vs Placebo (Normal Saline) Plus Paclitaxel: serious adverse events |
Source Trial comparisons
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/NCT00738699
GET https://conductscience.org/api/trials/v1/NCT00738699/events?page=2