Know Cancer

or
forgot password

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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colon Cancer, Colorectal Cancer, Gastrointestinal Cancer, Metastatic Colorectal Cancer, Rectal Cancer

Thank you

Trial Information

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


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 RECIST

- ECOG 0 or 1

- adequate laboratory values

Exclusion Criteria:

- history of 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-EGFR, c-MET, and/or IGFR inhibitor

- prior treatment with AMG 102 or AMG 479

- prior treatment with chemotherapy or radiotherapy
- prior treatment with targeted therapy
- known allergy or hypersensitivity to panitumumab, AMG 102, or AMG 479

- history of interstitial lung disease

- clinically significant cardiovascular disease
- active inflammatory bowel disease

- known 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
- any uncontrolled concurrent illness or history of any medical condition that could
interfere with the interpretation of the study results

- major surgical procedure
- other investigational procedures or drugs

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Phase 1: subject incidence of selected adverse events and laboratory abnormalities

Outcome Time Frame:

Phase 1: after ~6 subjects enrolled + 1-2 months after the 6th subject is enrolled

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Canada: Health Canada

Study ID:

20060447

NCT ID:

NCT00788957

Start Date:

November 2008

Completion Date:

September 2012

Related Keywords:

  • Colon Cancer
  • Colorectal Cancer
  • Gastrointestinal Cancer
  • Metastatic Colorectal Cancer
  • Rectal Cancer
  • panitumumab
  • vectibix
  • AMG 102
  • AMG 479
  • colon cancer
  • rectal cancer
  • colorectal cancer
  • metastatic colorectal cancer
  • EGFR inhibitor
  • IGF inhibitor
  • c-MET inhibitor
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Gastrointestinal Neoplasms

Name

Location