Colorectal CancerNCT06195514
Expanded Access to TAK-113 for Adults With Metastatic Colorectal Cancer (mCRC)
A study testing TAK-113 in people with Colorectal Cancer, run by Takeda.
Trial summary
The expanded access program allows people to gain access to an unlicensed treatment on compassionate grounds. This expanded access program provides adults with refractory metastatic colorectal cancer (mCRC) and who cannot neither adequately be treated by current standard of care nor participate in a clinical study… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- TAK-113
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) physical status of 0-2.
- Histologically and/or cytologically documented metastatic colorectal adenocarcinoma.
- Received all locally available and appropriate prior standard therapies and no other satisfactory treatment option is available for this condition. Participants may have received either prior TAS-102 or regorafenib. Must have progressed on or intolerant to fluoropyrimidine-, oxaliplatin-, and irinotecan- based chemotherapies, anti-vascular endothelial growth factor (VEGF) therapy, and, if rat sarcoma (RAS) wild-type, an anti- epidermal growth factor receptor (EGFR) therapy if available locally for this condition.
- Adequate bone marrow and organ function as defined by the following:
- Absolute neutrophil count of ≥1.5×10^9 per liter, platelet count of ≥75×10^9 per liter, and hemoglobin ≥8 grams per deciliter (g/dL).
- Serum total bilirubin ≤1.5 times the upper limit of normal (ULN)
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- Urine dipstick ≤1+ for proteinuria or ≤30 milligrams per deciliter (mg/dL) in urinalysis, unless quantitative protein is <1000 milligram (mg) in a 24-hour urine sample or urine protein: creatinine ratio on spot urine testing is ≤1.9.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase levels ≤2.5 times the ULN (participants with liver metastases must have ALT and AST levels ≤5 times the ULN).
- Serum creatinine ≤1.5 times the ULN or creatinine clearance ≥60 milliliters per minute (mL/min).
- Ineligible for other clinical trials of investigational drugs for refractory mCRC, if available.
Who cannot join
- Received systemic anticancer therapies [including chemotherapy, tyrosine-kinase inhibitors (TKIs) and endocrine therapy] within 2 weeks prior to the first dose of study drug.
- NOTE: If participant is currently receiving TAK-113 outside of a clinical trial and benefitting from treatment, they may still be considered provided they meet all other criteria.
- Uncontrolled hypertension as defined per local institution.
- Any unresolved toxicities from a previous antitumor treatment greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 grade 1 (except for alopecia or neurotoxicity grade≤2).
- Major surgery within the last 60 days or have had any other minor surgery or invasive procedure within the last 4 weeks.
- Any thromboembolic events (including deep vein thrombosis, and pulmonary embolism) within the past 6 months, or history of stroke and/or transient ischemic attack within the last 12 months.
About this study
Official title: Expanded Access Program: Fruquintinib for Patients With Metastatic Colorectal Cancer Who Progressed After Standard Therapy
The expanded access program allows people to gain access to an unlicensed treatment on compassionate grounds. This expanded access program provides adults with refractory metastatic colorectal cancer (mCRC) and who cannot neither adequately be treated by current standard of care nor participate in a clinical study access to TAK-113 until TAK-113 becomes commercially available in the respective country or the adult does no longer seem to benefit from treatment with TAK-113.
Read the detailed description
This is an expanded access program in which the drug being given is called TAK-113. This study will provide early access to TAK-113 until commercial availability in the respective country, for eligible participants with refractory mCRC who cannot adequately be treated by current standard of care and who cannot enter a clinical trial.
All participants will receive TAK-113 5 mg oral capsules in a 3 weeks on/1 week off schedule for each 4-week cycle.
As a part of the expanded access program, there will be a voluntary non-interventional real-world data collection of information.
This is a multi-center international program. Participants will continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, the treatment becomes commercially available, or halting of product development.
- Conditions
- Colorectal Cancer
- Being tested
- TAK-113
- Keywords
- Drug Therapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-113Drug
Also called Fruquintinib, HMPL-013
Description: TAK-113 5 mg capsules, orally, once daily, in a 3 weeks on/1 week off schedule for each 4-week cycle per treatment guidelines.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195514
- Sponsor's protocol ID
- TAK-113 EAP
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2023
- Last updated
- 30 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program: Fruquintinib for Patients With Metastatic Colorectal Cancer Who Progressed After Standard Therapy
- ClinicalTrials.gov ID
- NCT06195514
- Acronym / sponsor ID
- TAK-113 EAP
- Conditions
- Colorectal Cancer
- Keywords
- Drug Therapy
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The expanded access program allows people to gain access to an unlicensed treatment on compassionate grounds. This expanded access program provides adults with refractory metastatic colorectal cancer (mCRC) and who cannot neither adequately be treated by current standard of care nor participate in a clinical study access to TAK-113 until TAK-113 becomes commercially available in the respective country or the adult does no longer seem to benefit from treatment with TAK-113.
Detailed description
This is an expanded access program in which the drug being given is called TAK-113. This study will provide early access to TAK-113 until commercial availability in the respective country, for eligible participants with refractory mCRC who cannot adequately be treated by current standard of care and who cannot enter a clinical trial.
All participants will receive TAK-113 5 mg oral capsules in a 3 weeks on/1 week off schedule for each 4-week cycle.
As a part of the expanded access program, there will be a voluntary non-interventional real-world data collection of information.
This is a multi-center international program. Participants will continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, the treatment becomes commercially available, or halting of product development.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Eastern Cooperative Oncology Group (ECOG) physical status of 0-2.
- Histologically and/or cytologically documented metastatic colorectal adenocarcinoma.
- Received all locally available and appropriate prior standard therapies and no other satisfactory treatment option is available for this condition. Participants may have received either prior TAS-102 or regorafenib. Must have progressed on or intolerant to fluoropyrimidine-, oxaliplatin-, and irinotecan- based chemotherapies, anti-vascular endothelial growth factor (VEGF) therapy, and, if rat sarcoma (RAS) wild-type, an anti- epidermal growth factor receptor (EGFR) therapy if available locally for this condition.
- Adequate bone marrow and organ function as defined by the following:
- Ineligible for other clinical trials of investigational drugs for refractory mCRC, if available.
Key exclusion criteria (6 listed)
- Received systemic anticancer therapies [including chemotherapy, tyrosine-kinase inhibitors (TKIs) and endocrine therapy] within 2 weeks prior to the first dose of study drug.
- NOTE: If participant is currently receiving TAK-113 outside of a clinical trial and benefitting from treatment, they may still be considered provided they meet all other criteria.
- Uncontrolled hypertension as defined per local institution.
- Any unresolved toxicities from a previous antitumor treatment greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 grade 1 (except for alopecia or neurotoxicity grade≤2).
- Major surgery within the last 60 days or have had any other minor surgery or invasive procedure within the last 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-113Also: Fruquintinib, HMPL-013Description: TAK-113 5 mg capsules, orally, once daily, in a 3 weeks on/1 week off schedule for each 4-week cycle per treatment guidelines. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- To obtain more information on the study, click this link.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
Questions about this trial
What is this clinical trial studying?
A study testing TAK-113 in people with Colorectal Cancer, run by Takeda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.