Trial · NCT01018563
An Open Label Extension Study of the Efficacy of MORAb-003
NCT01018563, Phase 2, Terminated, Morphotek; results first posted 2021-12-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Open Label Extension Study of the Efficacy of MORAb-003. Trials, record NCT01018563. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01018563
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open Label Extension Study of the Efficacy of MORAb-003
- NCT number
- NCT01018563
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Morphotek
- Conditions
- Epithelial Ovarian Cancer
- Interventions
- MORAb-003
- First posted
- 2009-11-23
- Last updated
- 2021-12-08
- Other registries' IDs
- eudract:2009-015825-36
- Results first posted
- 2021-12-08
- Limitations and caveats
- Study was terminated by sponsor due to futile results in the NCT00849667 (MORAb003-004) study.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response | From screening of parent study (NCT00318370) until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only) | The duration of CA125 response, was defined the time from the date of the initial CA125 response (i.e., prior to enrollment in the parent study, was the starting point for assessment) to the first documentation of progressive disease (PD) by either Gynecologic Cancer Inter Group (GCIG) criteria for CA125 level or by the date of death due to any cause, whichever occurred first. Disease progression per CA125 was defined as the first of 2 consecutive CA125 values greater than (\>) twice the upper limit of normal (ULN) (i.e. 35 kilo unit per liter \[kU/L\]) on two occasions. C= data censored at earlier non-PD assessment if PD did not occur. |
| Secondary | Progression-Free Survival (PFS) by GCIG | From the first dose of study medication in the parent study (NCT00318370) until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only) | PFS was defined as the time from the date of first dose of study medication during the parent study MORAb-003-002 (NCT00318370) to the date of disease progression (either by GCIG for CA125 criteria or standard RECIST v.1.0 criteria) or to the date of death due to any cause in this study. PD per CA125 was defined as the first of 2 consecutive CA125 values \>2\*ULN (35 kU/L) on two occasions. Participants who were alive with no disease progression were censored at either the date of last CA125 assessment or date of last objective tumor evaluation, whichever was later. PFS was also censored if a participant received a non-study anticancer therapy or procedure, with censoring occurring at the date of the last RECIST or CA125 assessment prior to the start of a non-study anticancer therapy or procedure (whichever was earlier). C= data censored at earlier non-PD assessment if PD did not occur. |
| Secondary | Overall Survival (OS) | From Baseline (Day 1) in the parent study (NCT00318370) until date of death from any cause in this study, or until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only) | OS was defined from the date of first dose of farletuzumab during the parent study MORAb-003-002 (NCT00318370) to date of death due to any cause. Participants who were alive had their OS time censored at the date they were last known to be alive. C= data censored at date participant was last known to be alive. |
| Secondary | Duration of Second Remission | From Baseline (Day 1) in the parent study (NCT00318370) until date of death from any cause in this study, or until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only) | The prolongation of second and subsequent responses to chemotherapy plus farletuzumab relative to initial remission was assessed. Length of first remission was determined in the parent study MORAb-003-002 (NCT00318370). The length of second remission (i.e., the first remission in this study) was calculated using the following formula: '(carboplatin/taxane start date in this study - carboplatin/taxane start date in NCT00318370 +1/30.4'. The length of second remission was censored at the date of study discontinuation if the participant did not receive any carboplatin/taxane therapy during this study. C = censored data. |
| Secondary | Duration of Third Remission | From Baseline (Day 1) of this study until date of death from any cause, or until the study was terminated (up to a maximum of 37.7 months) | The length of third remission (i.e., second remission in this study) was calculated using the following formula: '(subsequent carboplatin/taxane start date in this study - carboplatin/taxane start date in NCT00318370 +1)/30.4'. The length of third remission was censored at the date of study discontinuation if the participant did not receive subsequent chemotherapy (carboplatin/taxane) during this study. Censored data is reported for all participants. |
| Other | Number of Participants With Best Overall Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.0 Criteria | From the start of the treatment until disease progression/recurrence (up to approximately 37.7 months) | Best overall response was the best response recorded from the start of treatment until disease progression/recurrence. Participants were assigned to one of the following categories of change in disease status: complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). CR was defined as CR in both target and non-target lesions with no new lesions. PR was defined as CR in target lesions and incomplete response or SD in non-target lesions with no new lesions, or PR in target lesions and non-PD in non-target lesions with no new lesions. SD was defined as SD in target lesions and non-PD in non-target lesions with no new lesions. PD was defined as PD in target lesions, any non-target lesions with either absence or presence of new lesions, or any target lesions, PD in non-target lesions with either absence or presence of new lesions, or any target or non-target lesions with new lesions. |
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 | Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response | From screening of parent study (NCT00318370) until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only) | Intent-to-treat population included all 3 participants who were enrolled. Data reported includes combined data from the parent study MORAb-003-002 (NCT00318370) and the current study MORAb-003-002A. | months | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) by GCIG | From the first dose of study medication in the parent study (NCT00318370) until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only) | Intent-to-treat population included all 3 participants who were enrolled. Data reported includes combined data from the parent study MORAb-003-002 (NCT00318370) and the current study MORAb-003-002A. | months | NUMBER |
| SECONDARY | Overall Survival (OS) | From Baseline (Day 1) in the parent study (NCT00318370) until date of death from any cause in this study, or until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only) | Intent-to-treat population included all 3 participants who were enrolled. Data reported includes combined data from the parent study MORAb-003-002 (NCT00318370) and the current study MORAb-003-002A. | months | NUMBER |
| SECONDARY | Duration of Second Remission | From Baseline (Day 1) in the parent study (NCT00318370) until date of death from any cause in this study, or until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only) | Intent-to-treat population included all 3 participants who were enrolled. Data reported includes combined data from the parent study MORAb-003-002 (NCT00318370) and the current study MORAb-003-002A. | months | NUMBER |
| SECONDARY | Duration of Third Remission | From Baseline (Day 1) of this study until date of death from any cause, or until the study was terminated (up to a maximum of 37.7 months) | Intent-to-treat population included all 3 participants who were enrolled. Here overall number of participants analyzed are participants who were available for this outcome measure. | months | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Best Overall Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.0 Criteria | From the start of the treatment until disease progression/recurrence (up to approximately 37.7 months) | Intent-to-treat population included all 3 participants who were enrolled. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response | Farletuzumab 62.5 mg/m^2 | Participant 1 (dose group: 62.5 mg/m^2)-C | 77.2 | months | |
| Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response | Farletuzumab 62.5 mg/m^2 | Participant 2 (dose group: 62.5 mg/m^2)-C | 73.3 | months | |
| Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response | Farletuzumab 100 mg/m^2 | Participant 3 (dose group: 100 mg/m^2) | 18.0 | months | |
| Progression-Free Survival (PFS) by GCIG | Farletuzumab 62.5 mg/m^2 | Participant 1 (dose group: 62.5 mg/m^2)-C: GCIG | 77.8 | months | |
| Progression-Free Survival (PFS) by GCIG | Farletuzumab 62.5 mg/m^2 | Participant 2 (dose group: 62.5 mg/m^2)-C: GCIG | 75.8 | months | |
| Progression-Free Survival (PFS) by GCIG | Farletuzumab 100 mg/m^2 | Participant 3 (dose group: 100 mg/m^2): GCIG | 25.1 | months | |
| Overall Survival (OS) | Farletuzumab 62.5 mg/m^2 | Participant 1 (dose group: 62.5 mg/m^2)-C | 78.3 | months | |
| Overall Survival (OS) | Farletuzumab 62.5 mg/m^2 | Participant 2 (dose group: 62.5 mg/m^2)-C | 76.7 | months | |
| Overall Survival (OS) | Farletuzumab 100 mg/m^2 | Participant 3 (dose group: 100 mg/m^2) | 59.5 | months | |
| Duration of Second Remission | Farletuzumab 62.5 mg/m^2 | Participant 1 (dose group: 62.5 mg/m^2) | 41.0 | months |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Farletuzumab 62.5 mg/m^2 | 2 | |
| Overall Study | STARTED | Farletuzumab 100 mg/m^2 | 1 | |
| Overall Study | COMPLETED | Farletuzumab 62.5 mg/m^2 | 0 | |
| Overall Study | COMPLETED | Farletuzumab 100 mg/m^2 | 0 | |
| Overall Study | NOT COMPLETED | Farletuzumab 62.5 mg/m^2 | 2 | |
| Overall Study | NOT COMPLETED | Farletuzumab 100 mg/m^2 | 1 |
Source ClinicalTrials.gov
Adverse events132
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 | Hypertension | Vascular disorders | Farletuzumab 62.5 mg/m^2 | 0 | 2 | 0 |
| other | Hypertension | Vascular disorders | Farletuzumab 100 mg/m^2 | 1 | 1 | 5 |
| other | Hypotension | Vascular disorders | Farletuzumab 62.5 mg/m^2 | 0 | 2 | 0 |
| other | Hypotension | Vascular disorders | Farletuzumab 100 mg/m^2 | 1 | 1 | 1 |
| other | Tooth extraction | Surgical and medical procedures | Farletuzumab 62.5 mg/m^2 | 1 | 2 | 1 |
| other | Tooth extraction | Surgical and medical procedures | Farletuzumab 100 mg/m^2 | 0 | 1 | 0 |
| other | Fatigue | General disorders | Farletuzumab 62.5 mg/m^2 | 1 | 2 | 2 |
| other | Fatigue | General disorders | Farletuzumab 100 mg/m^2 | 1 | 1 | 11 |
| other | Asthenia | General disorders | Farletuzumab 62.5 mg/m^2 | 1 | 2 | 1 |
| other | Asthenia | General disorders | Farletuzumab 100 mg/m^2 | 0 | 1 | 0 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Farletuzumab 62.5 mg/m^2 | 0 | 2 |
| Total, all-cause mortality | Farletuzumab 100 mg/m^2 | 0 | 1 |
| Total, other adverse events | Farletuzumab 62.5 mg/m^2 | 2 | 2 |
| Total, other adverse events | Farletuzumab 100 mg/m^2 | 1 | 1 |
| Total, serious adverse events | Farletuzumab 62.5 mg/m^2 | 1 | 2 |
| Total, serious adverse events | Farletuzumab 100 mg/m^2 | 1 | 1 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Farletuzumab 62.5 mg/m^2 vs Farletuzumab 100 mg/m^2: deaths from any cause | Trial comparisons |
| Farletuzumab 62.5 mg/m^2 vs Farletuzumab 100 mg/m^2: serious adverse events | 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/NCT01018563
GET https://conductscience.org/api/trials/v1/NCT01018563/events?page=2