Clinical trial · Interventional
Safety of AMG 706 Plus Panitumumab Plus Chemotherapy in the Treatment of Subjects With Metastatic Colorectal Cancer
An Open-Label, Dose-Finding Study to Evaluate the Safety of AMG 706 Plus Panitumumab Plus Chemotherapy in the Treatment of Subjects With Metastatic Colorectal Cancer
NCT00101894CI-TRIAL-00008030completedPhase 1ClinicalTrials.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 study is to characterize the safety and tolerability of AMG 706 plus panitumumab when administered with either FOLFIRI or FOLFOX4 chemotherapy regimens. This is a Phase 1b clinical study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 706 | Drug | Motesanib | ALIAS |
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
| FOLFOX-4 | Drug | FOLFOX Regimen | ALIAS |
| Panitumumab (Part 1a only) | Biological | Panitumumab | ALIAS |
Design
Arms and outcomes
Arms (14)
- type
- EXPERIMENTAL
- label
- Part 2 AMG 706 (MTD) + FOLFOX-4
- description
- Maximum Tolerated Dose of AMG 706 established in Part 1b + FOLFOX-4
- interventionNames
- Drug: FOLFOX-4
- Drug: AMG 706
- type
- EXPERIMENTAL
- label
- 125 mg QD AMG 706 + FOLFOX-4
- description
- 125 mg QD AMG 706 + FOLFOX-4
- interventionNames
- Drug: FOLFOX-4
- Drug: AMG 706
- type
- EXPERIMENTAL
- label
- 50 mg QD AMG706 + panitumumab + FOLFIRI
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For complete inclusion and exclusion criteria, please refer to the investigator. Inclusion Criteria 1. Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form 2. Diagnosis of metastatic colorectal adenocarcinoma (may have received 1 prior chemotherapy regimen for metastatic CRC) 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Adequate hematological function 5. Adequate renal function 6. Adequate hepatic function 7. Life expectancy of greater than or equal to 3 months as documented by the investigator Exclusion Criteria: 1. More than 1 prior chemotherapy regimen for metastatic CRC 2. Central nervous system (CNS) metastases 3. History of venous thrombosis 4. Myocardial infarction, cerebrovascular accident, transient ischemic attack, grade 2 or greater peripheral vascular disease, congestive heart failure, ongoing arrhythmias requiring medication, or unstable angina within 1 year before study enrollment 5. History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on screening chest computed tomograph (CT) scan 6. Average systolic blood pressure \> 150mm Hg or average diastolic blood pressure of \> 90mm Hg 7. Radiotherapy within 28 days of study enrollment or within 14 days of study enrollment for peripheral lesions 8. Prior AMG 706, oral inhibitors of AMG706, panitumumab, or another anti-EGFr monoclonal antibody (mAb) (e.g., cetuximab \[Erbitux®\] or EMD 72000) 9. Systemic chemotherapy within 28 days before study enrollment 10. Major surgery within 28 days or minor surgery within 7days of study enrollment 11. History of life threatening ventricular arrhythmia (eg, sustained ventricular tachycardia) 12. Female and male subjects of childbearing potential not using adequate contraceptive precautions 13. Participation in therapeutic clinical trials within 30 days before study enrollment 14. Not recovered from all previous therapies 15. Clinically significant open would, ulcer or fracture 16. Any co-morbid medical condition that would increase the risk of toxicity
References
Publications (1)
- DERIVEDTebbutt N, Kotasek D, Burris HA, Schwartzberg LS, Hurwitz H, Stephenson J, Warner DJ, Chen L, Hsu CP, Goldstein D. Motesanib with or without panitumumab plus FOLFIRI or FOLFOX for the treatment of metastatic colorectal cancer. Cancer Chemother Pharmacol. 2015 May;75(5):993-1004. doi: 10.1007/s00280-015-2694-y. Epub 2015 Mar 15. PMID 25772756