Clinical trial · Interventional
An Open Label Extension Study of the Efficacy of MORAb-003
An Open Label Extension Study of the Efficacy of MORAb-003 in Subjects With Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse
NCT01018563CI-TRIAL-00055421terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was terminated by sponsor due to futile results in NCT00849667 study.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MORAb-003 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MORAb-003
- description
- Maintenance infusions of MORAb-003 every 3 weeks
- interventionNames
- Drug: MORAb-003
Primary outcomes (1)
- measure
- Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response
- timeFrame
- 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)
- description
- 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 outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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. Exclusion Criteria: • Subjects that discontinued the MORAb-003-002 study for any reason.
References
Publications (0)
Data not yet available
No reference posted for this study.