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An Uncontrolled, Open-label, Phase II Study in Subjects With Metastatic Adenocarcinoma of the Colon or Rectum Who Are Receiving First Line Chemotherapy With mFOLFOX6 (Oxaliplatin/ Folinic Acid/5-fluorouracil [5-FU]) in Combination With Regorafenib


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Neoplasms

Thank you

Trial Information

An Uncontrolled, Open-label, Phase II Study in Subjects With Metastatic Adenocarcinoma of the Colon or Rectum Who Are Receiving First Line Chemotherapy With mFOLFOX6 (Oxaliplatin/ Folinic Acid/5-fluorouracil [5-FU]) in Combination With Regorafenib


Inclusion Criteria:



- Male or female subjects aged ≥ 18 years

- Histological or cytological documentation of adenocarcinoma of the colon or rectum

- Suitable to receive mFOLFOX6 regimen as first line metastatic treatment

- At least 1 measurable lesion as per RECIST version 1.1

- Unresectable or unlikely becoming resectable metastatic disease

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Life expectancy of at least 3 months

- Adequate bone marrow, liver, and renal function

Exclusion Criteria:

- Prior systemic anticancer therapy for metastatic colorectal cancer (CRC). Adjuvant
chemotherapy for CRC (Stage I, II, III) is permitted, if the adjuvant therapy ended >
6 months before screening and recurrent disease was documented.

- Prior treatment with antivascular endothelial growth factor (anti-VEGF) agents and
any signal transduction inhibitors (STIs)

- Uncontrolled hypertension

- Subjects with symptoms, signs, or history of brain metastases

- Any hemorrhage or bleeding event ≥ Common Terminology Criteria for Adverse Events
(CTCAE) Grade 3 within 4 weeks of start of study treatment

- Sensory neuropathy (> CTCAE Grade 1), unresolved toxicity > CTCAE Grade 1 attributed
to any prior therapy/procedure excluding alopecia

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Outcome Time Frame:

6 months after last patient first treatment

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

11728

NCT ID:

NCT01289821

Start Date:

February 2011

Completion Date:

October 2013

Related Keywords:

  • Colorectal Neoplasms
  • Neoplasms
  • Colorectal Neoplasms

Name

Location

Hinsdale, Illinois  60521