Clinical trial · Interventional
Open Label Extension Study of Conatumumab and Ganitumab (AMG 479)
A Phase 2 Open Label Extension Study of Conatumumab and AMG 479
NCT01327612CI-TRIAL-00050226completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this protocol is to allow continued treatment with conatumumab and/or ganitumab, with or without chemotherapy, to participants who completed a separate Amgen-sponsored conatumumab or ganitumab study without disease progression whose previous studies were closed.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Carcinoid | Neuroendocrine Tumor | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Locally Advanced | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Biological | Bevacizumab | ALIAS |
| Conatumumab | Biological | Conatumumab | ALIAS |
| Ganitumab | Biological | Ganitumab | ALIAS |
| Modified FOLFOX6 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Conatumumab Monotherapy
- description
- Participants will continue to receive conatumumab every 2 weeks (Q2W) or every 3 weeks (Q3W) at the same dose and regimen as at the conclusion of the parent study.
- interventionNames
- Biological: Conatumumab
- type
- EXPERIMENTAL
- label
- Conatumumab + Ganitumab
- description
- Participants will receive conatumumab and ganitumab by intravenous infusion at the same dose and regimen as at the conclusion of the parent study.
- interventionNames
- Biological: Conatumumab
- Biological: Ganitumab
- type
- EXPERIMENTAL
- label
- Ganitumab Monotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * To be enrolled in this study, subjects must be currently enrolled in a prior Amgen-sponsored conatumumab or AMG 479 study and are eligible according to the parent study to receive their next dose of conatumumab (with or without co-therapy), or AMG 479 alone. Subjects must have their eligibility assessed for this study and be enrolled within 30 days of their last treatment on the parent protocol Exclusion Criteria: * Discontinued from a conatumumab study due to an adverse event considered by the investigator to be related to conatumumab treatment, including intolerance to conatumumab * Subjects determined to have disease progression during their participation in the parent Amgen study * Woman or man with partner of childbearing potential not consenting to use adequate contraceptive precautions ie, double barrier contraceptive methods (eg, diaphragm plus condom), or abstinence during the course of the study and for 6 months after the last dose of protocol-specified therapy administration * Subject is pregnant or breast feeding, or planning to become pregnant within 6 months after the last dose of protocol-specified therapy administration * Male subject with a pregnant partner who is not willing to use a condom during treatment and for an additional 6 months after the last dose of protocol-specified therapy administration * Subject has previously entered this study * Subject will not be available for protocol required study visits, to the best of the subject and investigator's knowledge * Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures
References
Publications (0)
Data not yet available
No reference posted for this study.