Epithelial Ovarian Cancer
Conditions
Keywords
Extension study, Epithelial ovarian cancer
Brief summary
An open label extension of the MORAb-003-002 study in order to continue the active patients in the MORAb-003-002 study on maintenance MORAb-003 infusions after the main study is closed.
Interventions
DRUGMORAb-003
Dose group to be determined by dose assigned in main study and patient's weight. Intravenous infusions are given every 3 weeks.
Sponsors
Morphotek
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of Informed consent. * Subjects must have been enrolled in and have met the inclusion/
Exclusion criteria
of the MORAb-003-002 study. * Subjects must have achieved a normalization of CA 125 levels and/or CR or PR (or stable disease and an investigator's assessment of a clinical benefit) after MORAb-003 in combination with standard chemotherapy and have not yet met the criteria for disease progression during participation in the MORAb-003-002 study. * Subjects must be currently receiving single-agent MORAb-003 maintenance therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany, United States
Participant flow
Recruitment details
Participants participated and received single-agent farletuzumab maintenance therapy in MORAb-003-002 study (NCT00318370), achieved normalization of cancer antigen 125 levels and/or tumor assessment of complete/partial response(or stable disease and an investigator's assessment of a clinical benefit) after receiving farletuzumab plus chemotherapy to enter study.
Pre-assignment details
Study enrolled 3 participants who participated in the MORAb-003-002 study (NCT00318370), achieved a normalization of CA 125 levels and/or complete response or partial response after MORAb-003 in combination with standard chemotherapy, and received single-agent MORAb-003 maintenance therapy.
Participants by arm
| Arm | Count |
|---|---|
| Farletuzumab- All Participants Participants received farletuzumab 62.5 or 100 mg/m\^2, intravenous infusion once weekly at the same dose level which participants received in the MORAb-003-002 (NCT00318370) parent study for up to 37.7 months in this study. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Termination of the study by Sponsor | 2 | 1 |
Baseline characteristics
| Characteristic | Farletuzumab- All Participants |
|---|---|
| Age, Continuous | 58.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 2 / 2 | 1 / 1 |
| serious Total, serious adverse events | 1 / 2 | 1 / 1 |
Outcome results
Primary
Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Farletuzumab 62.5 mg/m^2 | Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response | Participant 1 (dose group: 62.5 mg/m^2)-C | 77.2 months |
| Farletuzumab 62.5 mg/m^2 | Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response | Participant 2 (dose group: 62.5 mg/m^2)-C | 73.3 months |
| Farletuzumab 100 mg/m^2 | Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response | Participant 3 (dose group: 100 mg/m^2) | 18.0 months |
Secondary
Duration of Second Remission
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Farletuzumab 62.5 mg/m^2 | Duration of Second Remission | Participant 1 (dose group: 62.5 mg/m^2) | 41.0 months |
| Farletuzumab 62.5 mg/m^2 | Duration of Second Remission | Participant 2 (dose group: 62.5 mg/m^2)-C | 74.2 months |
| Farletuzumab 100 mg/m^2 | Duration of Second Remission | Participant 3 (dose group: 100 mg/m^2) | 29.5 months |
Secondary
Duration of Third Remission
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Farletuzumab 62.5 mg/m^2 | Duration of Third Remission | 37.3 months |
| Farletuzumab 100 mg/m^2 | Duration of Third Remission | 25.0 months |
Secondary
Overall Survival (OS)
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Farletuzumab 62.5 mg/m^2 | Overall Survival (OS) | Participant 1 (dose group: 62.5 mg/m^2)-C | 78.3 months |
| Farletuzumab 62.5 mg/m^2 | Overall Survival (OS) | Participant 2 (dose group: 62.5 mg/m^2)-C | 76.7 months |
| Farletuzumab 100 mg/m^2 | Overall Survival (OS) | Participant 3 (dose group: 100 mg/m^2) | 59.5 months |
Secondary
Progression-Free Survival (PFS) by GCIG
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Farletuzumab 62.5 mg/m^2 | Progression-Free Survival (PFS) by GCIG | Participant 1 (dose group: 62.5 mg/m^2)-C: GCIG | 77.8 months |
| Farletuzumab 62.5 mg/m^2 | Progression-Free Survival (PFS) by GCIG | Participant 2 (dose group: 62.5 mg/m^2)-C: GCIG | 75.8 months |
| Farletuzumab 100 mg/m^2 | Progression-Free Survival (PFS) by GCIG | Participant 3 (dose group: 100 mg/m^2): GCIG | 25.1 months |
Other Pre-specified
Number of Participants With Best Overall Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.0 Criteria
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.
Time frame: From the start of the treatment until disease progression/recurrence (up to approximately 37.7 months)
Population: Intent-to-treat population included all 3 participants who were enrolled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Farletuzumab 62.5 mg/m^2 | Number of Participants With Best Overall Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.0 Criteria | CR | 1 Participants |
| Farletuzumab 62.5 mg/m^2 | Number of Participants With Best Overall Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.0 Criteria | SD | 1 Participants |
| Farletuzumab 100 mg/m^2 | Number of Participants With Best Overall Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.0 Criteria | CR | 1 Participants |
| Farletuzumab 100 mg/m^2 | Number of Participants With Best Overall Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.0 Criteria | SD | 0 Participants |