A double-blind, randomized, comparative, multicenter, exploratory, and placebo-controlled Phase II trial of FOLFIRI plus MSC1936369B or placebo with a safety run-in part as second-line treatment of metastatic K Ras mutated colorectal cancer subjects

Merck Serona S.A., Geneva, Switzerland0 sites196 target enrollmentJanuary 13, 2010

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Merck Serona S.A., Geneva, Switzerland
Enrollment: 196
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 13, 2010

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Serona S.A., Geneva, Switzerland

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed KRAS mutated colon/rectum cancer.
•Subject’s disease must have progressed during or after a first\-line treatment for metastatic disease with oxaliplatin and fluoropyrimidins based chemotherapy with or without bevacizumab.
•Evidence of metastatic measurable disease at trial entry as per Response Evaluation Criteria in Solid Tumors \[RECIST v1\.0] (at least one measurable lesion). Complete tumor assessment performed within 14 days prior to first trial drug administration.
•Age of subjects at least 18 years.
•Subject has read, understood and given informed consent, fully understands requirements of the trial, and is willing to comply with all trial visits and assessments.
•Women of childbearing potential must have a negative blood pregnancy test at the screening visit. For the purposes of this trial, women of childbearing potential are defined as: All female subjects after puberty unless they are post\-menopausal for at least two years, are surgically sterile or are sexually inactive.”
•Female subjects of childbearing potential and male subjects with female partners of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 2 weeks prior to screening, during and four weeks after the last dose of trial medication. Adequate contraception is defined as two barrier methods, or one barrier method with a spermicide, or intrauterine device. The use of
•hormonal contraceptives should be avoided in female subjects
•of childbearing potential due to possible drug\-drug
•interaction.

Exclusion Criteria

•Bone marrow impairment as evidenced by hemoglobin \< 9\.0 g/dL, neutrophil count \< 1\.5 x 10^9/L, and/or platelets \< 100 x 10^9/L.
•Renal impairment as evidenced by serum creatinine \> 1\.5 x ULN (upper limit of normal) and/or calculated creatinine clearance \< 50 mL/min.
•Liver function and liver cell integrity abnormality as defined by total bilirubin \> 1\.5 x ULN, or AST/ALT \> 2\.5 x ULN, for subjects with liver involvement AST/ALT \> 5 x ULN.
•History of central nervous system (CNS) metastases, unless subject has been previously treated for CNS metastases, is stable by CT scan without evidence of cerebral edema, and has no requirements for corticosteroids or anticonvulsants.
•History of difficulty of swallowing, malabsorption or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the tested product.
•Eastern Cooperative Oncology Group Performance Status (ECOG PS) greater than 1\.
•Known HIV positivity, active hepatitis C, or active hepatitis B.
•Has received extensive prior radiotherapy on more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation. Prior radiation for local disease management is allowed if last fraction was completed at least 4 weeks prior to trial entry.
•Has received chemotherapy or any investigational drug in the 4 weeks prior to trial first drug administration.
•Has a history of any other significant medical disease such as major gastric or small bowel surgery, or has a psychiatric condition that might impair the subject’s well being or preclude full participation in the trial.