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Report for Clinical Trial NCT03520946

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase IIb Study of RAMucirumab in Combination With TAS102 vs. TAS102 Monotherapy in Chemotherapy Refractory Metastatic Colorectal Cancer Patients

Interventional, prospective, randomized (1:1), controlled, open label, multicenter phase IIb study in patients with advanced metastatic colorectal cancer. The scope of the trial is to evaluate overall survival of either regimen (TAS102 +/- Ramucirumab) and evaluate safety and tolerability.

NCT03520946 Colorectal Cancer
MeSH:Colorectal Neoplasms
HPO:Neoplasm of the large intestine

2 Interventions

Name: Ramucirumab

Description: 8 mg/kg iv over 60 min on d1+15, q4w
Type: Drug
Group Labels: 1

Arm A (ramucirumab + TAS102)

Name: TAS 102

Description: 35mg/m2 p.o. twice daily (BID) d1-5 and d8-12, q4w
Type: Drug
Group Labels: 2

Arm A (ramucirumab + TAS102) Arm B (TAS102 only)


Primary Outcomes

Description: Overall survival according to Kaplan-Meier

Measure: Overall survival

Time: Up to 3 years

Secondary Outcomes

Description: ORR defined as the proportion of patients with complete or partial remission according to RECIST 1.1

Measure: Overall response rate (ORR)

Time: Up to 3 years

Description: DCR defined as the proportion of patients with complete or partial remission and stable disease according to RECIST 1.1

Measure: Disease control rate (DCR)

Time: Up to 3 years

Description: PFS, defined as the time from enrollment/randomization to the first occurrence of progression, as determined by the investigator using CT criteria, or death from any cause

Measure: Progression-free survival (PFS)

Time: Up to 3 years

Description: OS rate at 6 and 12 months, defined as patients who are alive after at 6 and 12 months, respectively

Measure: Overall survival (OS) at different time points

Time: 6 months and 1 year

Description: Efficacy (ORR) in patients who develop neutropenia grade ≥2 (ANC ≤1500/μl) in cycle 1

Measure: Efficacy (ORR)

Time: Up to 3 years

Description: Efficacy (PFS) in patients who develop neutropenia grade ≥2 (ANC ≤1500/μl) in cycle 1

Measure: Efficacy (PFS)

Time: Up to 3 years

Description: Efficacy (OS) in patients who develop neutropenia grade ≥2 (ANC ≤1500/μl) in cycle 1

Measure: Efficacy (OS)

Time: Up to 3 years

Description: Quality of life (QoL) as measured by EORTC-QLQ-C30 at d1 of each cycle and on EOT (end of treatment).

Measure: Quality of life I (QoL)

Time: Up to 1 year

Description: Quality of life (QoL) as measured by EQ-5D-5L at d1 of each cycle and on EOT.

Measure: Quality of life II (QoL)

Time: Up to 1 year

Other Outcomes

Description: ORR according to gene expression, mutational profiles and plasma biomarkers

Measure: Explorative: Overall response rate (ORR)

Time: Up to 3 years

Description: OS according to gene expression, mutational profiles and plasma biomarkers

Measure: Explorative: Overall survival (OS)

Time: Up to 3 years

Description: PFS according to gene expression, mutational profiles and plasma biomarkers

Measure: Explorative: Progression-free survival (PFS)

Time: Up to 3 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

Intolerance is defined as a permanent discontinuation of the respective treatment resulting from toxicity 2. Signed informed consent before start of specific protocol procedure 3. Histologically or cytologically documented diagnosis of adenocarcinoma of the colon or rectum 4. Presence of at least one measurable site of disease following RECIST 1.1 criteria 5. ECOG (Eastern Cooperative Oncology Group) performance 0-1 6. Known RAS and BRAF V600E mutational status 7. Life expectancy of at least 3 months 8. Adequate hematological, hepatic and renal function parameters: 1. Leukocytes ≥3000/mm³, platelets ≥100,000/mm³, neutrophil count (ANC) ≥1500/μL, hemoglobin ≥9 g/dL (5.58 mmol/L) 2. Adequate coagulation function as defined by International Normalized Ratio (INR) ≤1.5, and a partial thromboplastin time (PTT) ≤5 seconds above the ULN (upper limit of normal) (unless receiving anticoagulation therapy). --- V600E ---

Patients will be stratified by the duration of previous anti-angiogenic therapy ≥ or <12 months in total, BRAF V600E mutation status (mutation vs. wildtype), RAS mutation status (mutation vs. wildtype), and randomized 1:1 to receive either ramucirumab/TAS102 (arm A) or TAS102 (arm B). --- V600E ---



HPO Nodes


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