MSC2015103B in Solid Tumors

NCT ID: NCT01453387

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-07-31

Brief Summary

The main purpose of this study is to test the experimental drug, MSC2015103B at different dose levels and on different treatment schedules, to see whether it is safe and can be tolerated when given to subjects once a day one day per week over a 21-day period or once a day three times per week over a 21-day period. The investigators would also like to find out how MSC2015103B is broken down by the body.

Additional purposes of the trial are to assess side effects of MSC2015103B and to find out whether MSC2015103B has anti-cancer effects. In addition, the investigators would like to explore pharmacokinetics.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1 - MSC2015103B (Schedule 1)

Group Type: EXPERIMENTAL

MSC2015103B

Intervention Type: DRUG

Schedule 1: MSC2015103B will be administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD establishment. Starting dose will be 150 microgram (mcg), which will be escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.

Part 1 - MSC2015103B (Schedule 2)

Group Type: EXPERIMENTAL

MSC2015103B

Intervention Type: DRUG

Schedule 2: MSC2015103B will be administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose will be 150 mcg, and will be escalated to 200 mcg subsequently.

Interventions

MSC2015103B

Schedule 1: MSC2015103B will be administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD establishment. Starting dose will be 150 microgram (mcg), which will be escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.

Intervention Type: DRUG

MSC2015103B

Schedule 2: MSC2015103B will be administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose will be 150 mcg, and will be escalated to 200 mcg subsequently.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Pathologically confirmed solid tumor preferably, but not exclusively, including pancreatic, thyroid, colorectal, non-small cell lung, endometrial, renal, breast, ovarian carcinoma, or melanoma which is locally advanced or metastatic, and either refractory after standard therapy for the disease or for which no effective standard therapy is available
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (<=) 1
• Has read and understands the informed consent form and is willing and able to give informed consent. Fully understands requirements of and willing to comply with all trial visits and assessments
• Evidence of measurable disease at trial entry as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.0.
• Willing to provide archival tissue samples for molecular analysis

Exclusion Criteria

• Bone marrow impairment as evidenced by hemoglobin less than (<) 9.0 gram per deciliter (g/dL), neutrophil count < 1.5 x 10^9 per liter (/L), and/or platelets <100 x 10^9/L per liter (/L)
• Renal impairment as evidenced by serum creatinine greater than (>) 1.5 x upper limit of normal (ULN) and/or calculated creatinine clearance < 50 milliliter per minute (mL/min) (Cockcroft-Gault formula)
• Liver function and liver cell integrity abnormality as defined by total bilirubin > 1.5 x ULN, or aspartate aminotransferase/alanine aminotransferase (AST/ALT) > 2.5 x ULN, for subjects with liver involvement AST/ALT > 5 x ULN. Subjects with albumin < 2.5 g/dL are also excluded
• History of central nervous system (CNS) metastases.
• History of difficulty of swallowing, malabsorption, or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the tested product.
• Chronic diarrhea that is >= Grade 2 in severity
• Clinically significant cardiac conduction abnormalities
• A left ventricular ejection fraction of < 45%
• A history of stroke or myocardial infarction within the past year
• A history of uveitis and scleritis
• Retinal pathology beyond normal age-related processes
• Evidence of a retinal vein occlusion on fluorescein angiogram or a history of retinal vein occlusion
• Subjects are also excluded if their ophthalmologist finds that their optic disc is at risk for a central retinal vein occlusion
• History of glaucoma
• Subjects requiring daily and/or chronic systemic steroids

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMD Serono

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck Serono, a division of Merck KGaA, Darmstadt, Germany

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Countries

United States

Other Identifiers

EMR 200064-001

Identifier Type: -

Identifier Source: org_study_id