Loading clinical trials...

A Phase I/II Study for the Safety and Efficacy of Panitumumab in Combination With TAS-102 for Patients With Colorectal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Phase I/II Study for the Safety and Efficacy of Panitumumab in Combination With TAS-102 for Patients With Colorectal Cancer

A Phase I/II Study for the Safety and Efficacy of Panitumumab in Combination With TAS-102 for Patients With RAS (KRAS, NRAS) Wild-type, Unresectable, Advanced/Recurrent Colorectal Cancer

NCT02613221•Takeda

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the combination of panitumumab and Triflridine/Tipiracil (FTD/TPI; TAS-102) in patients with RAS wild-type metastatic colorectal cancer (CRC) refractory to standard chemotherapy (oxaliplatin, fluoropyrimidines, irinotecan and angiogenesis inhibitors).

Detailed Description

The purpose of this study is to evaluate the combination of panitumumab and TAS-102 in patients with RAS wild-type metastatic colorectal cancer (CRC) refractory to standard chemotherapy (oxaliplatin, fluoropyrimidines, irinotecan and angiogenesis inhibitors). Patients who are judged eligible for the study based on the inclusion and exclusion criteria will be received panitumumab (6 mg/kg) every 2 weeks and TAS-102 (35 mg/m² given orally twice a day in a 28-day) in 2-week cycle of 5 days of treatment followed by a 2-day rest period, and then a 14-day rest period. A maximum of 58 participants will be enrolled.

Eligibility

Age

20 - 74 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Investigator and subinvestigator judge a candidate is understand clinical trial and comply this protocol.
•2. Participants who have given written consent to take part in the study after detailed explanation of the study prior to enrollment
•3. Aged ≥20 to \<75 years at the time of informed consent
•4. Participants with unresectable adenocarcinoma originating in the large intestine (excluding carcinoma of the appendix and anal canal cancer)
•5. Participants with lesion(s) that can be evaluated. It is essential to be evaluated the tumor according to the Response Evaluation Criteria in Solid Tumors (RECIST) ver. 1.1.
•6. Participants who have received chemotherapies for metastatic colorectal cancer and are refractory to or failing those chemotherapies\* including; fluoropyrimidines, irinotecan, oxaliplatin, and an angiogenesis inhibitors.
•\*: Refractory to or failing those chemotherapies are defied as following;
•* If recurrence is observed by imaging during neoadjuvant/adjuvant therapy, or within 6 months of the completion of adjuvant therapy.
•* If imaging or clinical progression is observed during or within 3 months of the last dose of chemotherapy for advanced cancer.
•* When it is determined that the drugs (ie, fluropyrimidines, oxaliplatin, irinotecan, and angiogenesis inhibitors) are not allowed to be resume due to intolerable AE toxicities (eg, serious allergic reaction and accumulative neuropathy).
+15 more criteria

Exclusion Criteria

•1. Has received anti-EGFR antibodies (cetuximab or panitumumab), regorafenib, or TAS-102.
•2. Has had treatment with radiotherapy and/or chemotherapy within 2 weeks (14 days) prior to study drug administration (except for limited field radiation in order to rescue of pain).
•3. Known brain metastasis or strongly suspected of brain metastasis
•4. Synchronous cancers or metachronous cancers with a disease-free period of ≥ 5 years (excluding colorectal cancer) excluding mucosal cancers cured or be possibly cured by regional resection (esophageal, stomach, and cervical cancer, non-melanoma skin cancer, bladder cancer, etc.).
•5. Body cavity fluid that requires treatment (pleural effusion, ascites, pericardial effusion, etc.)
•6. Participants who do not want to use contraception to prevent pregnancy, and women who are pregnant or breast-feeding, or test positive for pregnancy
•7. Any investigational agent received within prior 4 weeks (28 days).
•8. Disease requiring systemic steroids for treatment (excluding topical steroids)
•9. History or obvious and extensive CT findings of interstitial pulmonary disease (interstitial pneumonia, pulmonary fibrosis, etc.)
•10. Intestinal paralysis, gastrointestinal obstruction, or uncontrollable diarrhea (incapacitating symptoms despite adequate treatment.
+8 more criteria

Locations (32)

Nagoya, Aichi-ken, Japan

Kashiwa, Chiba, Japan

Matsuyama, Ehime, Japan

Kitakyushu, Fukuoka, Japan

Kurume, Fukuoka, Japan

Hakodate, Hokkaido, Japan

Kushiro, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Amagasaki, Hyōgo, Japan

Kobe, Hyōgo, Japan

Key Dates

Start Date

December 7, 2015

Primary Completion Date

October 6, 2017

Completion Date

March 30, 2018

Last Updated

July 31, 2019

Enrollment

ACTUAL participants

Conditions

Colorectal Cancer

Interventions

Panitumumab + TAS-102

DRUG

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

NCT04704661

Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

View study

RECRUITINGPHASE1

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

NCT06696768

Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase I/II Study for the Safety and Efficacy of Panitumumab in Combination With TAS-102 for Patients With Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors