Phase 2
Completed N=12
Open Label Extension Study of Conatumumab and Ganitumab (AMG 479)
Solid Tumors · Carcinoid · Colorectal Cancer · Locally Advanced
Source: ClinicalTrials.gov NCT01327612 ↗
Enrolled (actual)
12
Serious AEs
66.7%
Results posted
Feb 2021
Primary outcomePrimary: Number of Participants With Adverse Events — 2; 1; 1; 1 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
2; 1; 1; 1; 2; 3 | — |
| PRIMARY Number of Participants With Serious Adverse Events |
1; 0; 1; 0; 1; 3 | — |
| SECONDARY Maximum Change From Baseline in Blood Pressure |
5.5; 7.0; 54.0; 37.0; 42.0; 26.0 | — |
| SECONDARY Minimum Change From Baseline in Blood Pressure |
-28.5; -45.0; -20.0; -21.0; -22.5; -29.0 | — |
| SECONDARY Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities |
0; 0; 1; 0; 2; 2 | — |
| SECONDARY Best Overall Response |
0; 1; 0; 1; 1; 0 | — |
| SECONDARY Number of Participants With Disease Progression or Death Due to Disease Progression |
1; 1; 1; 0; 2; 2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01327612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.