ARQ 197 in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
Primary Purpose
Metastatic Colorectal Cancer
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Tivantinib
Placebo
Cetuximab
Irinotecan
Sponsored by

About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Colorectal cancer, wild-type KRAS, irinotecan, cetuximab, second-line therapy
Eligibility Criteria
Inclusion Criteria:
- Participants with surgically unresectable locally advanced or metastatic disease who have received one prior line of chemotherapy. (The Phase 1 portion of the study will be open for enrollment for subjects who received 1 or more prior therapies). Both relapsed and refractory CRC are allowed.
- All participants must express the wild-type form of the gene KRAS.
- Measurable disease according to RECIST (Response Evaluation Criteria In Solid Tumors) criteria, Version 1.1.
- Male or female >= to 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, Version 4.0, grade <= to 1.
Adequate bone marrow, liver, and renal functions, defined as:
- Hemoglobin >= to 9.0 g/dL (transfusion and/or growth factor support allowed).
- Absolute neutrophil count (ANC) >= to 1.5 x 10^9/L.
- Platelet count >= to 75 x 10^9/L.
- Serum creatinine <= to 1.5 x upper limit of normal (ULN) or creatinine clearance >= to 60 mL/min.
- Alanine transaminase (ALT), aspartate transaminase (AST), and alkaline phosphatase <= to 2.5 x ULN in subjects with no liver metastasis and <= to 5.0 x ULN in participants with liver metastasis.
- Total bilirubin <= to 1.5 x ULN (<= to 4 x ULN and direct bilirubin <= to 1.5 x ULN is acceptable for subjects with Gilbert's syndrome).
- Male and female participants of child-bearing potential must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last investigational drug dose received.
- All female participants of childbearing potential must each have a negative pregnancy test (serum or urine) result before initiating study treatment.
- Participants must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an Independent Ethics Committee (IEC) or Institutional Review Board (IRB)-approved informed consent form (ICF) (including HIPAA authorization, if applicable) before performance of any study specific procedures or tests.
Exclusion Criteria:
- Prior therapy with an Epidermal Growth Factor Receptor (EGFR) inhibitor.
- History of malignancy other than CRC, unless there is an exception that the malignancy has been cured and no tumor-specific treatment for the malignancy has been administered within the 5 years prior to initiation of study treatment (participants with a history of basal cell carcinoma or benign tumor of cervix can be enrolled if diagnosis and treatment occurred less than 3 years prior to randomization).
- Anticipation of need for a major surgical procedure or radiation therapy (RT) during the study.
- Treatment with chemotherapy, radiotherapy, surgery, immunotherapy, biological therapy, or any other investigational anticancer agent within 4 weeks prior to start of study treatment.
History of cardiac disease:
- Congestive heart failure defined as Class II to IV per New York Heart Association (NYHA) classification.
- Active coronary artery disease (CAD).
- Previously diagnosed bradycardia or other cardiac arrhythmia defined as Grade 2 or higher according to NCI CTCAE, version 4.0, or uncontrolled hypertension.
- Myocardial infarction that occurred within 6 months prior to start of study treatment (myocardial infarction that occurred greater than 6 months before the start of study treatment is permitted).
- Malabsorption syndrome, chronic diarrhea (lasting greater than 4 weeks), inflammatory bowel disease, or partial bowel obstruction.
- Known metastatic brain or meningeal tumors, unless the participant is greater than 6 months from definitive therapy, has a negative imaging study within 4 weeks of first dose of study treatment, and is clinically stable (no concomitant therapy, including supportive therapy with steroids or anticonvulsant medications) with respect to the tumor at the time of first dose of study treatment.
- Uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis.
- Pericardial or pleural effusion (eg, requiring drainage) or pericardial involvement with the tumor. Participants with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor.
- Clinically significant active infection that requires antibiotic therapy.
- Previous administration of ARQ 197.
- Substance abuse or medical, psychological or social conditions that may, in the opinion of the Investigator, interfere with the participant's participation in the clinical trial or evaluation of the clinical trial results.
- Any condition that is unstable or that could jeopardize the safety of the subject and the participant's protocol compliance including known human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
- Inability to swallow oral medications.
- Pregnant or nursing females.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
Phase 2: Tivantinib, cetuximab, irinotecan
Phase 2: Placebo, cetuximab, irinotecan
Phase 1: Tivantinib, cetuximab, irinotecan
Arm Description
Tivantinib in combination with irinotecan and cetuximab.
Placebo in combination with irinotecan and cetuximab
Tivantinib in combination with irinotecan and cetuximab.
Outcomes
Primary Outcome Measures
Progression-Free Survival (PFS) Following Treatment With Tivantinib (ARQ 197) in Combination With Irinotecan and Cetuximab in Participants With Metastatic Colorectal Cancer With Wild-Type K-ras Oncogene (KRAS) Who Have Received Front-Line Systemic Therapy
Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause (as of data cutoff 12 Oct 2012).
Progression-Free Survival (PFS) Using Computed Best Response Following Treatment With Tivantinib (ARQ 197) in Combination With Irinotecan and Cetuximab in Participants With Metastatic Colorectal Cancer Who Have Received Front-Line Systemic Therapy
Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause (as of data cutoff 12 Oct 2012).
Secondary Outcome Measures
Best Overall Tumor Response and Objective Response Rate Following Treatment With Tivantinib (ARQ 197) in Combination With Irinotecan and Cetuximab in Subjects With Metastatic Colorectal Cancer Who Have Received Front-Line Systemic Therapy
Best overall tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria included complete response (CR) defined as the disappearance of all target lesions; partial response (PR) defined as a ≥30% decrease in the longest diameter of target lesions; stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Objective response was defined as CR+PR.
Overall Survival (OS) Following Treatment With Tivantinib (ARQ 197) in Combination With Irinotecan and Cetuximab in Participants With Metastatic Colorectal Cancer With Wild-Type K-ras Oncogene (KRAS) Who Have Received Front-Line Systemic Therapy
Overall survival is defined as the time from randomization date to the date of death.
Duration of Response and Stable Disease Following Treatment With Tivantinib (ARQ 197) in Combination With Irinotecan and Cetuximab in Participants With Metastatic Colorectal Cancer With Wild-Type KRAS Who Have Received Front-Line Systemic Therapy
Duration of response was defined for participants with complete response (CR)/partial response (PR) as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progressive disease. Duration of stable disease (SD) was defined for participants whose best response was SD at the time from the randomization date to the date of the first documentation of progressive disease. Based on Response Evaluation Criteria in Solid Tumors version 1.1, CR is defined as a disappearance of all target lesions, PR is defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Treatment-Emergent Adverse Events Reported in ≥ 10% of Participants Following Treatment With Tivantinib (ARQ 197) in Combination With Irinotecan and Cetuximab in Subjects With Metastatic Colorectal Cancer Who Have Received Front-Line Systemic Therapy
A treatment-emergent adverse event (TEAE) was defined as an AE that had an onset date on or after the first dose of study drug, cetuximab, or irinotecan up to and including 30 days after the last dose of any study drug and worsened in severity after the first dose of study drug relative to the pre-treatment state.
Treatment-Emergent Infection and Infestation Adverse Events Following Treatment With Tivantinib (ARQ 197) in Combination With Irinotecan and Cetuximab in Participants With Metastatic Colorectal Cancer Who Have Received Front-Line Systemic Therapy
A treatment-emergent adverse event (TEAE) was defined as an AE that had an onset date on or after the first dose of study drug, cetuximab, or irinotecan up to and including 30 days after the last dose of any study drug and worsened in severity after the first dose of study drug relative to the pre-treatment state.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01075048
Brief Title
ARQ 197 in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
Official Title
A Randomized, Placebo-Controlled, Phase 1/2 Study Of ARQ 197 in Combination With Irinotecan and Cetuximab in Subjects With Metastatic Colorectal Cancer With Wild-type KRAS Who Have Received Front-Line Systemic Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 26, 2010 (Actual)
Primary Completion Date
October 12, 2012 (Actual)
Study Completion Date
February 20, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
ARQ 197 or placebo in combination with irinotecan and cetuximab in participants with metastatic colorectal cancer (CRC), in participants with wild-type KRAS alleles who have failed front-line systemic therapy, to evaluate the safety, tolerability, and efficacy of ARQ 197, define the recommended dose for Phase 2.
After the recommended dose is determined for Phase 2, participants receive study drug or placebo with irinotecan and cetuximab.
Detailed Description
Phase 1/2 Multicenter study:
Phase 1 portion is open-label to evaluate the safety of ARQ 197 administered in combination with irinotecan and cetuximab.
Phase 2 portion is designed as a randomized, double-blind placebo-controlled study to assess the efficacy and safety of ARQ 197 or matching placebo administered in combination with irinotecan and cetuximab.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Colorectal cancer, wild-type KRAS, irinotecan, cetuximab, second-line therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Phase 1 is single group open label with one arm. Phase 2 is parallel, double-blind design with two arms.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase 2: Tivantinib, cetuximab, irinotecan
Arm Type
Experimental
Arm Description
Tivantinib in combination with irinotecan and cetuximab.
Arm Title
Phase 2: Placebo, cetuximab, irinotecan
Arm Type
Placebo Comparator
Arm Description
Placebo in combination with irinotecan and cetuximab
Arm Title
Phase 1: Tivantinib, cetuximab, irinotecan
Arm Type
Experimental
Arm Description
Tivantinib in combination with irinotecan and cetuximab.
Intervention Type
Drug
Intervention Name(s)
Tivantinib
Other Intervention Name(s)
ARQ 197
Intervention Description
ARQ 197 is supplied as a 120-mg capsule, administered twice daily at the dose determined in the Phase 1 portion of the study. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match ARQ 197, administered twice daily. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met.
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Cetuximab 500 mg/ m^2 intravenous infusion over 120 minutes at the first cycle, then over 60-minutes at subsequent cycles. Administered on Day 1 and Day 15 of each 28 day cycle. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met.
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
60 minutes after cetuximab, Irinotecan 180 mg/m^2 intravenous infusion over 30 - 90 minutes. Administered on Day 1 and Day 15 of each 28 day cycle. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) Following Treatment With Tivantinib (ARQ 197) in Combination With Irinotecan and Cetuximab in Participants With Metastatic Colorectal Cancer With Wild-Type K-ras Oncogene (KRAS) Who Have Received Front-Line Systemic Therapy
Description
Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause (as of data cutoff 12 Oct 2012).
Time Frame
Baseline up to 80 weeks postdose
Title
Progression-Free Survival (PFS) Using Computed Best Response Following Treatment With Tivantinib (ARQ 197) in Combination With Irinotecan and Cetuximab in Participants With Metastatic Colorectal Cancer Who Have Received Front-Line Systemic Therapy
Description
Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause (as of data cutoff 12 Oct 2012).
Time Frame
Baseline up to 80 weeks postdose
Secondary Outcome Measure Information:
Title
Best Overall Tumor Response and Objective Response Rate Following Treatment With Tivantinib (ARQ 197) in Combination With Irinotecan and Cetuximab in Subjects With Metastatic Colorectal Cancer Who Have Received Front-Line Systemic Therapy
Description
Best overall tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria included complete response (CR) defined as the disappearance of all target lesions; partial response (PR) defined as a ≥30% decrease in the longest diameter of target lesions; stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Objective response was defined as CR+PR.
Time Frame
Baseline up to 2 years 10 months postdose
Title
Overall Survival (OS) Following Treatment With Tivantinib (ARQ 197) in Combination With Irinotecan and Cetuximab in Participants With Metastatic Colorectal Cancer With Wild-Type K-ras Oncogene (KRAS) Who Have Received Front-Line Systemic Therapy
Description
Overall survival is defined as the time from randomization date to the date of death.
Time Frame
Baseline up to 5 years 1 month postdose
Title
Duration of Response and Stable Disease Following Treatment With Tivantinib (ARQ 197) in Combination With Irinotecan and Cetuximab in Participants With Metastatic Colorectal Cancer With Wild-Type KRAS Who Have Received Front-Line Systemic Therapy
Description
Duration of response was defined for participants with complete response (CR)/partial response (PR) as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progressive disease. Duration of stable disease (SD) was defined for participants whose best response was SD at the time from the randomization date to the date of the first documentation of progressive disease. Based on Response Evaluation Criteria in Solid Tumors version 1.1, CR is defined as a disappearance of all target lesions, PR is defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Time Frame
Baseline up to 80 weeks postdose
Title
Treatment-Emergent Adverse Events Reported in ≥ 10% of Participants Following Treatment With Tivantinib (ARQ 197) in Combination With Irinotecan and Cetuximab in Subjects With Metastatic Colorectal Cancer Who Have Received Front-Line Systemic Therapy
Description
A treatment-emergent adverse event (TEAE) was defined as an AE that had an onset date on or after the first dose of study drug, cetuximab, or irinotecan up to and including 30 days after the last dose of any study drug and worsened in severity after the first dose of study drug relative to the pre-treatment state.
Time Frame
Baseline up to 30 days after last dose, up to 5 years 1 month
Title
Treatment-Emergent Infection and Infestation Adverse Events Following Treatment With Tivantinib (ARQ 197) in Combination With Irinotecan and Cetuximab in Participants With Metastatic Colorectal Cancer Who Have Received Front-Line Systemic Therapy
Description
A treatment-emergent adverse event (TEAE) was defined as an AE that had an onset date on or after the first dose of study drug, cetuximab, or irinotecan up to and including 30 days after the last dose of any study drug and worsened in severity after the first dose of study drug relative to the pre-treatment state.
Time Frame
Baseline up to 30 days after last dose, up to 5 years 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants with surgically unresectable locally advanced or metastatic disease who have received one prior line of chemotherapy. (The Phase 1 portion of the study will be open for enrollment for subjects who received 1 or more prior therapies). Both relapsed and refractory CRC are allowed.
All participants must express the wild-type form of the gene KRAS.
Measurable disease according to RECIST (Response Evaluation Criteria In Solid Tumors) criteria, Version 1.1.
Male or female >= to 18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, Version 4.0, grade <= to 1.
Adequate bone marrow, liver, and renal functions, defined as:
Hemoglobin >= to 9.0 g/dL (transfusion and/or growth factor support allowed).
Absolute neutrophil count (ANC) >= to 1.5 x 10^9/L.
Platelet count >= to 75 x 10^9/L.
Serum creatinine <= to 1.5 x upper limit of normal (ULN) or creatinine clearance >= to 60 mL/min.
Alanine transaminase (ALT), aspartate transaminase (AST), and alkaline phosphatase <= to 2.5 x ULN in subjects with no liver metastasis and <= to 5.0 x ULN in participants with liver metastasis.
Total bilirubin <= to 1.5 x ULN (<= to 4 x ULN and direct bilirubin <= to 1.5 x ULN is acceptable for subjects with Gilbert's syndrome).
Male and female participants of child-bearing potential must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last investigational drug dose received.
All female participants of childbearing potential must each have a negative pregnancy test (serum or urine) result before initiating study treatment.
Participants must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an Independent Ethics Committee (IEC) or Institutional Review Board (IRB)-approved informed consent form (ICF) (including HIPAA authorization, if applicable) before performance of any study specific procedures or tests.
Exclusion Criteria:
Prior therapy with an Epidermal Growth Factor Receptor (EGFR) inhibitor.
History of malignancy other than CRC, unless there is an exception that the malignancy has been cured and no tumor-specific treatment for the malignancy has been administered within the 5 years prior to initiation of study treatment (participants with a history of basal cell carcinoma or benign tumor of cervix can be enrolled if diagnosis and treatment occurred less than 3 years prior to randomization).
Anticipation of need for a major surgical procedure or radiation therapy (RT) during the study.
Treatment with chemotherapy, radiotherapy, surgery, immunotherapy, biological therapy, or any other investigational anticancer agent within 4 weeks prior to start of study treatment.
History of cardiac disease:
Congestive heart failure defined as Class II to IV per New York Heart Association (NYHA) classification.
Active coronary artery disease (CAD).
Previously diagnosed bradycardia or other cardiac arrhythmia defined as Grade 2 or higher according to NCI CTCAE, version 4.0, or uncontrolled hypertension.
Myocardial infarction that occurred within 6 months prior to start of study treatment (myocardial infarction that occurred greater than 6 months before the start of study treatment is permitted).
Malabsorption syndrome, chronic diarrhea (lasting greater than 4 weeks), inflammatory bowel disease, or partial bowel obstruction.
Known metastatic brain or meningeal tumors, unless the participant is greater than 6 months from definitive therapy, has a negative imaging study within 4 weeks of first dose of study treatment, and is clinically stable (no concomitant therapy, including supportive therapy with steroids or anticonvulsant medications) with respect to the tumor at the time of first dose of study treatment.
Uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis.
Pericardial or pleural effusion (eg, requiring drainage) or pericardial involvement with the tumor. Participants with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor.
Clinically significant active infection that requires antibiotic therapy.
Previous administration of ARQ 197.
Substance abuse or medical, psychological or social conditions that may, in the opinion of the Investigator, interfere with the participant's participation in the clinical trial or evaluation of the clinical trial results.
Any condition that is unstable or that could jeopardize the safety of the subject and the participant's protocol compliance including known human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
Inability to swallow oral medications.
Pregnant or nursing females.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Study Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211-1850
Country
United States
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32836
Country
United States
City
Centralia
State/Province
Illinois
ZIP/Postal Code
62801
Country
United States
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
372203
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
City
Bayonne
ZIP/Postal Code
64100
Country
France
City
Lille cedex
ZIP/Postal Code
59020
Country
France
City
Marseille cedex
ZIP/Postal Code
13285
Country
France
City
Halle
Country
Germany
City
Leer
ZIP/Postal Code
26789
Country
Germany
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
City
Munchen
ZIP/Postal Code
81675
Country
Germany
City
Milano
ZIP/Postal Code
20089
Country
Italy
City
Reggio-Emilia
ZIP/Postal Code
42100
Country
Italy
City
Treviglio
ZIP/Postal Code
24047
Country
Italy
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
City
Kursk
ZIP/Postal Code
305035
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
City
Saint-Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
City
Samara
ZIP/Postal Code
443031
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ARQ 197 in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
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