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Panitumumab+ TAS-102

Phase 1

Colorectal Cancer | Small molecule | Oncology |Takeda Pharmaceutical Company Limited|Last Updated: Jul 31, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

Panitumumab+ TAS-102 · 1 trial · 1 indication

Phase 1 1
NCT02613221A Phase I/II Study for the Safety and Efficacy of Panitumumab in Combination With TAS-102 for Patients With Colorectal CancerColorectal Cancer
COMPLETED56 Analytics
PHASE1COMPLETED
A Phase I/II Study for the Safety and Efficacy of Panitumumab in Combination With TAS-102 for Patients With Colorectal Cancer
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Dose Limiting Toxicity (DLT) With Panitumumab Plus TAS-102 Combination Therapy
Up to approximately 1 month

DLT was evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 and was defined as any of the following events: 1. Grade 4 neutropenia for more than 7 days under maximum supportive therapy; 2. Febrile neutropenia; 3. Platelet counts decreased of Grade 3 requiring platelet transfusion or blood platelet decreased of Grade 4; 4. If Course 2 was not initiated within 14 days due to AE related to the protocol treatment; 5. Grade 3 or higher non-hematologic toxicity that was considered clinically significant, except the following cases, Grade 3 gastrointestinal symptoms that could be controlled with supportive therapy (eg, appropriate use of antiemetics, antidiarrheals), and Grade 3 or higher electrolyte abnormalities that were not deemed clinically significant.

Progression Free Survival (PFS) Rate at 6 Months
Up to 6 months

PFS rate at 6 months was defined as the crude rate of surviving participants who survived or were not determined as progressive at 6 months from the day of enrollment. Although the subjects who had no imaging data on progression at 6 months after enrollment or the subjects who had lost to follow-up were included in the denominator, these subjects were not handled as progression-free. Progression included both progression disease (PD) based on diagnostic imaging assessed according to response evaluation criteria in solid tumors (RECIST) ver 1.1 and primary disease progression that cannot be confirmed by diagnostic imaging (clinical progression). PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

Secondary Endpoints

Overall Survival (OS)
From date of enrollment until the death, assessed up to approximately 29 months
Progression Free Survival (PFS)
From date of enrollment until the date of progression or death, assessed up to approximately 29 months
Response Rate (RR)
From date of enrollment until the end of follow-up period, assessed up to approximately 29 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
panitumumab + TAS-102 combination therapyEXPERIMENTALPanitumumab 6 mg/kg every 2 weeks, plus TAS-102 35 mg/m² given orally twice a day in 5 days followed by a 2-day rest period for 2-week cycle, and then a 14-day rest period (28 days per 1 course).

Interventions

NameTypeDescription
Panitumumab + TAS-102DRUGpanitumumab + TAS-102 combination therapy
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Eligibility Criteria

Age Range20 Years to 74 Years
SexALL
Healthy VolunteersNo
Study Sites32

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...

Countries:Japan
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Frequently asked questions about Panitumumab+ TAS-102

What is Panitumumab + TAS-102 used for in colorectal cancer?

Panitumumab + TAS-102 is an investigational combination being studied for the treatment of colorectal cancer. It combines panitumumab, a monoclonal antibody, with TAS-102, a small molecule. The combination is being evaluated in a Phase 1 clinical trial to assess its safety and efficacy in patients with colorectal cancer.

Who is developing Panitumumab + TAS-102?

Panitumumab + TAS-102 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical research on this combination for colorectal cancer, with a completed Phase 1 trial in Japan.

What phase is Panitumumab + TAS-102 in?

Panitumumab + TAS-102 is in Phase 1 clinical development. The Phase 1 trial, which has been completed, was designed to evaluate the safety and efficacy of the combination in patients with colorectal cancer. The drug is investigational and not yet approved for any use.

What clinical trials is Panitumumab + TAS-102 in?

Panitumumab + TAS-102 has one completed clinical trial, identified as NCT02613221. This Phase 1 study, titled 'A Phase I/II Study for the Safety and Efficacy of Panitumumab in Combination With TAS-102 for Patients With Colorectal Cancer,' enrolled 56 participants in Japan and included patients aged 20 years and older.

Is Panitumumab + TAS-102 the same as TAS-102 alone?

Panitumumab + TAS-102 is a combination regimen that includes TAS-102, a small molecule, plus panitumumab, a monoclonal antibody. It is not the same as TAS-102 alone, as the combination adds panitumumab to the treatment. The combination is being studied for colorectal cancer.