Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Ramucirumab

Angiogenesis Inhibitors

Growth Inhibitors

Patients randomized to arm A will receive ramucirumab 8 mg/kg iv over 60 min on d1+15, q4w and TAS102 35mg/m2 p.o. twice daily (BID) d1-5 and 8-12, q4w until progression or intolerance or completion of 6 cycles.

Patients randomized to arm B will receive TAS102 35mg/m2 p.o. twice daily (BID) d1-5 and 8-12, q4w until progression, intolerance or completion of 6 cycles.

35mg/m2 p.o. twice daily (BID) d1-5 and d8-12, q4w

TAS 102

Salah-Eddin Al-Batran, Prof. Dr.

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.

This is an 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 and evaluate safety and tolerability.

Patients with advanced metastatic and inoperable, colorectal cancer who have progressed on/after or did not tolerate: fluoropyrimidines, oxaliplatin, irinotecan, anti-angiogenic therapies (bevacizumab, aflibercept, regorafenib or ramucirumab) and when indicated anti-EGFR (epidermal growth factor receptor) antibodies (cetuximab or panitumumab) will be included in this trial.

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). Concurrent use of other chemotherapy is not allowed.

Two interim safety analyses will be conducted when 10 and 40 patients are fully documented in arm A after receiving 2 cycles (one 4-week cycle comprises ramucirumab 8mg/kg administered at d1 and d15 and TAS102 35mg/m2 p.o. twice daily administered on d1-5 and d8-12). The analysis will be reviewed by the lead coordinating investigator (Prof. Dr. Kasper) and members of the steering committee and then by the data safety monitoring board. It is not planned to discontinue recruitment for the interim safety analyses.

Arm A (ramucirumab/TAS102) Patients randomized to arm A will receive ramucirumab 8 mg/kg iv over 60 min on d1+15, q4w and TAS102 35mg/m2 p.o. twice daily (BID) d1-5 and 8-12, q4w until progression or intolerance or completion of 6 cycles.

Arm B (TAS102) Patients randomized to arm B will receive TAS102 35mg/m2 p.o. twice daily (BID) d1-5 and 8-12, q4w until progression, intolerance or completion of 6 cycles.

In both arms, tumor assessments (CT or MRI) are performed before enrollment/randomization and then every 8 weeks (every 2nd cycle) during therapy and every 12 weeks during follow-up until progression/relapse, death or end of follow-up. A change from CT into MRI in the follow-up period is possible at any time.

During treatment, clinical visits (blood cell counts, detection of toxicity) will be performed prior to every treatment dose of ramucirumab or every two weeks in arm B or if ramucirumab was discontinued in arm A. Safety of TAS102 +/- ramucirumab will be monitored continuously by careful monitoring of all adverse events (AEs) and serious adverse events (SAEs) reported. Every 4 weeks during therapy Quality of life (QoL) will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30) and the EuroQol 5 dimensions 5-level version (EQ-5D-5L).

RAMucirumab in Combination Wth TAS102 vs. TAS102 Alone in Chemotherapy Refractory Metastatic Colorectal Cancer Patients

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

ORR according to gene expression, mutational profiles, plasma biomarkers and radiologic analysis

OS according to gene expression, mutational profiles, plasma biomarkers and radiologic analysis

PFS according to gene expression, mutational profiles, plasma biomarkers and radiologic analysis

Overall survival according to Kaplan-Meier

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

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

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

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

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

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

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

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

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

Eli Lilly and Company

Trium Analysis Online GmbH

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Symptoms and General Pathology

Rare Diseases

Nasopharyngeal Carcinoma

Recurrence

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Patients with EBER positive nasopharyngeal carcinoma with recurrent or metastatic disease

Eligible patients who consent to participate will receive oral TAS-102 bid for days 1-5 and 8-12 of a 28 day cycle.

TAS-102

Boon Cher Goh

This is a single-arm, non-randomised study including patients with EBER positive nasopharyngeal carcinoma with recurrent or metastatic disease not amenable to curative treatment, who have received at least 1 regimen of platinum containing chemotherapy.

HYPOTHESIS

Given the favourable activity of fluoropyrimidines (5Fluorouracil) which inhibit thymidylate synthase (TS) in nasopharyngeal carcinoma, the investigators hypothesized that TAS-102 may demonstrate efficacy in NPC through targeting TS as well as an additional mechanism of incorporating trifluridine triphosphate into DNA.

OBJECTIVES OF TRIAL

1. To determine the clinical efficacy of TAS-102 in recurrent and metastatic NPC
2. To assess the safety and tolerability of TAS-102 in the study population of R/M NPC
3. To study the pharmacokinetics of TAS-102 in the study population of R/M NPC
4. To study potential predictive biomarkers for clinical benefit from TAS-102

Eligible patients who consent to participate will receive oral TAS-102 for days 1-5 and 8-12 of a 28 day cycle.

A Trial of LONSURF in Recurrent/Metastatic Nasopharyngeal Carcinoma

A Phase 2 Trial of TAS 102 in Recurrent/Metastatic Nasopharyngeal Carcinoma

As defined by complete response (CR) + partial response (PR) + stable disease (SD) at 12 weeks of assessment using RECIST 1.1.

as defined as the time from initiation of treatment to radiological progression, clinical deterioration or death.

National University Hospital, Singapore

Bevacizumab

Irinotecan

Antineoplastic Agents, Immunological

Topoisomerase I Inhibitors

Enzyme Inhibitors

Male and females aged 18 years and older with histologically confirmed metastatic or unresectable (not amenable to curative therapy) colorectal cancer.

Liposomal irinotecan

TAS102

Cancer Connect

Dustin Deming, MD

This study is being done to see if combining liposomal irinotecan with TAS102 and bevacizumab confers clinical benefit for patients with treatment refractory metastatic colorectal cancer.

This prospective phase II, single arm, single site trial will evaluate the efficacy of the combination of liposomal irinotecan (nal-IRI), TAS102, and bevacizumab for the treatment of patients with mismatch repair proficient, metastatic or unresectable colorectal cancer that has previously been treated with 5-fluorouracil, oxaliplatin, irinotecan and if RAS wild-type an anti-EGFR agent. A total of 25 patients will be accrued at UW Carbone Cancer Center. Subject enrollment will occur over 12 months with the total duration of the trial expected to be 3 years.

Primary Objective

* To determine the progression free survival (PFS) of patients with metastatic colorectal cancer treated in the treatment refractory setting with liposomal irinotecan in combination with TAS102 and bevacizumab.

Secondary Objectives

* To evaluate the objective response rate (ORR) of liposomal irinotecan in combination with bevacizumab and TAS102.
* To assess the safety and tolerability of these regimens in this setting.
* To determine the impact of the timing of irinotecan use in prior lines of therapy on the ORR and PFS observed with these nal-IRI containing treatment regimens

This is a nonrandomized, single arm, open-label study of the combination of liposomal irinotecan with TAS102 and bevacizumab in patients with treatment refractory metastatic colorectal cancer.

Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer

Phase II Study of Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer

PFS is defined as the time from D1 of treatment with the study combination until the criteria for disease progression is met as defined by RECIST 1.1 criteria or death as a result of any cause.

ORR will include confirmed complete response (CR) + confirmed partial response (PR) per RECIST 1.1 divided by the number of patients receiving at least one dose of proposed combination.

Grade 3 and 4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (version 5.0) (CTCAE v5.0)

PFS will be compared between those subjects who were treated in the last 4 months with an irinotecan containing regimen versus those who were not

Ipsen

University of Wisconsin, Madison

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Fruquintinib 4mg d1-21, q4w TAS102 35mg/m2，bid，d1-5，d15-19，q4w

Fruquintinib, TAS102

Ting Deng, MD

Jiayu Zhang, MD

This is a prospective, single-center, open, single-arm clinical study to observe and evaluate the efficacy and safety of Fruquintinib combined with TAS102 for second-line treatment of advanced gastric cancer.

A prospective study of Fruquintinib combined with TAS-102 for the posterior line treatment of advanced colorectal cancer is ongoing (NCT05004831). Both Fuquinitinib and TAS-102 are oral drugs, which are convenient to use and avoid the burden of frequent hospitalization. Whether this combination has considerable efficacy in gastric cancer is not clear.

Fruquintinib Combined With TAS102 for Advanced Gastric Cancer

Phase II Clinical Study of Fruquintinib Combined TAS102 for Second-line Treatment of Advanced Gastric Cancer

Time from the start of treatment to the progression of the disease

Time from the start of treatment to the occurrence of death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
RAMucirumab in Combination Wth TAS102 vs. TAS102 Alone in Chemotherapy Refractory Metastatic Colorectal Cancer Patients	NCT03520946	Colorectal Canc...	Ramucirumab TAS 102	18 Years -	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
A Trial of LONSURF in Recurrent/Metastatic Nasopharyngeal Carcinoma	NCT04627961	Metastatic Naso... Recurrent Nasop...	TAS-102	21 Years - 99 Years	National University Hospital, Singapore
A Trial of LONSURF in Recurrent/Metastatic Nasopharyngeal Carcinoma	NCT04627961	Metastatic Naso... Recurrent Nasop...	TAS-102	21 Years - 99 Years	National University Hospital, Singapore
Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer	NCT05854498	Metastatic Colo...	Liposomal irino... TAS102 Bevacizumab	18 Years -	University of Wisconsin, Madison
Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer	NCT05854498	Metastatic Colo...	Liposomal irino... TAS102 Bevacizumab	18 Years -	University of Wisconsin, Madison
RAMucirumab in Combination Wth TAS102 vs. TAS102 Alone in Chemotherapy Refractory Metastatic Colorectal Cancer Patients	NCT03520946	Colorectal Canc...	Ramucirumab TAS 102	18 Years -	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Fruquintinib Combined With TAS102 for Advanced Gastric Cancer	NCT06102785	Gastric Cancer	Fruquintinib, T...	18 Years -	Tianjin Medical University Cancer Institute and Hospital
Fruquintinib Combined With TAS102 for Advanced Gastric Cancer	NCT06102785	Gastric Cancer	Fruquintinib, T...	18 Years -	Tianjin Medical University Cancer Institute and Hospital

Spots Global Cancer Trial Database for tas102

Every month we try and update this database with for tas102 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tas102

Every month we try and update this database with for tas102 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tas102 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.