Clinical trial · Interventional
Panitumumab Combination Study With Rilotumumab or Ganitumab in Wild-type Kirsten Rat Sarcoma Virus Oncogene Homolog (KRAS) Metastatic Colorectal Cancer (mCRC)
A Randomized, Phase 1b/2 Trial of AMG 102 or AMG 479 in Combination With Panitumumab Versus Panitumumab Alone in Subject With Wild-Type KRAS Metastatic Colorectal Cancer
NCT00788957CI-TRIAL-00079533completedPhase 1 / Phase 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)
This study is a global, multicenter, open-label phase 1b and randomized, double-blinded, 2 part, phase 2 study designed to evaluate the safety and efficacy of rilotumumab or ganitumab in combination with panitumumab versus panitumumab alone in patients with metastatic colorectal cancer whose tumors are wild-type KRAS status.
Conditions
Conditions (5)
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 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ganitumab | Drug | Ganitumab | ALIAS |
| Panitumumab | Drug | Panitumumab | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Rilotumumab | Drug | Rilotumumab | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Part 1: Panitumumab + Rilotumumab
- description
- Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
- interventionNames
- Drug: Panitumumab
- Drug: Rilotumumab
- type
- ACTIVE_COMPARATOR
- label
- Part 2: Panitumumab Alone
- description
- Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
- interventionNames
- Drug: Panitumumab
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * metastatic adenocarcinoma of the colon or rectum * wild-type KRAS tumor status * radiographic evidence of disease progression during or following treatment with irinotecan and/or oxaliplatin containing chemotherapy for mCRC * measurable disease \>/= 20 mm per Response Evaluation Criteria In Solid Tumors (RECIST) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * adequate laboratory values Exclusion Criteria: * history of central nervous system (CNS) metastases * history of another primary cancer, unless: * curatively resected non-melanomatous skin cancer * curatively treated cervical carcinoma in situ * other primary solid tumor treated with curative intent and no known active disease present for \>/= 5 years * prior treatment with an anti-epithelial growth factor receptor (EGFR), hepatocyte growth factor receptor (HGFR, c-MET), and/or insulin-like growth factor receptor (IGFR) inhibitor * prior treatment with AMG 102 or AMG 479 * prior treatment with chemotherapy or radiotherapy \</= 21 days * prior treatment with targeted therapy \</= 30 days * known allergy or hypersensitivity to panitumumab, AMG 102, or AMG 479 * history of interstitial lung disease * clinically significant cardiovascular disease \</= 1 year * active inflammatory bowel disease * known human immunodeficiency virus (HIV), hepatitis C, or hepatitis B infection * any co-morbid disease or condition that could increase the risk of toxicity * serious or non-healing wound \</= 35 days * any uncontrolled concurrent illness or history of any medical condition that could interfere with the interpretation of the study results * major surgical procedure \</= 35 days or minor surgical procedure \</= 14 days * other investigational procedures or drugs \</= 30 days
References
Publications (2)
- BACKGROUNDVan Cutsem E, Eng C, Nowara E, Swieboda-Sadlej A, Tebbutt NC, Mitchell E, Davidenko I, Stephenson J, Elez E, Prenen H, Deng H, Tang R, McCaffery I, Oliner KS, Chen L, Gansert J, Loh E, Smethurst D, Tabernero J. Randomized phase Ib/II trial of rilotumumab or ganitumab with panitumumab versus panitumumab alone in patients with wild-type KRAS metastatic colorectal cancer. Clin Cancer Res. 2014 Aug 15;20(16):4240-50. doi: 10.1158/1078-0432.CCR-13-2752. Epub 2014 Jun 11. PMID 24919569
- DERIVEDPeeters M, Kafatos G, Taylor A, Gastanaga VM, Oliner KS, Hechmati G, Terwey JH, van Krieken JH. Prevalence of RAS mutations and individual variation patterns among patients with metastatic colorectal cancer: A pooled analysis of randomised controlled trials. Eur J Cancer. 2015 Sep;51(13):1704-13. doi: 10.1016/j.ejca.2015.05.017. Epub 2015 Jun 3. PMID 26049686