Phase 2
N=11
Panitumumab Combination Study With Rilotumumab or Ganitumab in Wild-type Kirsten Rat Sarcoma Virus Oncogene Homolog (KRAS) Metastatic Colorectal Cancer (mCRC)
Colon Cancer · Colorectal Cancer · Gastrointestinal Cancer · Metastatic Colorectal Cancer · Rectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00788957 ↗Enrolled (actual)
11
Serious AEs
23.7%
Results posted
Jul 2015
Primary outcome: Primary: Part 1: Number of Participants With Dose-limiting Toxicities (DLT) — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Panitumumab (Drug); Ganitumab (Drug); Rilotumumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NantBioScience, Inc.
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Number of Participants With Dose-limiting Toxicities (DLT) |
— | — |
| PRIMARY Part 2: Percentage of Participants With an Objective Response |
21; 31; 22 | — |
| SECONDARY Duration of Response - Part 2 |
3.7; 5.1; 3.7 | — |
| SECONDARY Time to Response - Part 2 |
1.8; 1.6; 1.7 | — |
| SECONDARY Disease Control Rate - Part 2 |
56; 71; 61 | — |
| SECONDARY Progression-free Survival (PFS) - Part 2 |
3.7; 5.2; 5.3 | — |
| SECONDARY On-treatment Progression-free Survival (PFS) - Part 2 |
3.8; 5.3; 5.3 | — |
| SECONDARY Overall Survival - Part 2 |
NA; NA; NA | — |
| SECONDARY Cmin, Cmax of Panitumumab |
42.5; 223 | — |
| SECONDARY Cmin, Cmax, for Rilotumumab |
120; 306 | — |
| SECONDARY Cmin for Panitumumab - Part 2 |
19.8; 22.8; 17.2; 34.8; 37.9; 29.8 | — |
| SECONDARY Cmax for Panitumumab - Part 2 |
114; 124; 118; 149; 154; 139 | — |
| SECONDARY Cmin for Rilotumumab - Part 2 |
70.1; 119; 143; 186; 181 | — |
| SECONDARY Cmax for Rilotumumab - Part 2 |
239; 316; 357; 397; 453; 421 | — |
| SECONDARY Cmin for Ganitumab - Part 2 |
19.8; 24.4; 28.9; 38.8; 39.7 | — |
| SECONDARY Cmax for Ganitumab - Part 2 |
218; 240; 244; 279; 274; 276 | — |
| SECONDARY Total Anti-Panitumumab Antibody Incidence - Part 2 |
6.3; 18.8; 17.4 | — |
| SECONDARY Total Anti-AMG 102 Antibody Incidence - Part 2 |
6.3 | — |
| SECONDARY Total Anti-AMG 479 Antibody Incidence - Part 2 |
17.4 | — |
| SECONDARY AUC for Rilotumumab |
2300 | — |
| SECONDARY AUC for Panitumumab |
1200 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00788957). 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.