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RecruitingPhase 2

A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)

A Phase II Study Investigating Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests fruquintinib with FOLFIRI, a mix of chemotherapy drugs, for colon or rectal cancer that has spread to other parts of the body. It is for adults who have already had one treatment plan for this cancer. The study will check how well the drugs work together and how safe they are.

This is an open-label multicenter, single-arm Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC). The main goals of this study are to: * Evaluate the efficacy of the combination of fruquintinib + FOLFIRI in the 2nd-line mCRC setting * Evaluate the safety of the combination of fruquintinib + FOLFIRI

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old.
  • A tissue test confirms adenocarcinoma, a type of colon or rectal cancer, that has spread. At least one tumor can be measured.
  • Your cancer does not have the genetic changes called MSI-H or BRAF V600. Other genetic changes are allowed.
  • You completed at least 2 cycles of your first treatment for cancer that has spread. It must have included oxaliplatin, a fluoropyrimidine, and a BEV-based drug.
  • The listing says prior treatment plans called FOLFOXIRI, BEV, and SOX/BEV are not allowed.
  • You can care for yourself and are out of bed or a chair for at least half the day, even if you cannot work (ECOG score 0–2).

Who can't join

  • You had other cancer treatment within 21 days before starting study treatment, more than one prior whole-body treatment plan for cancer that has spread, or any prior FOLFIRI or irinotecan-based treatment.
  • You had major surgery within 4 weeks before the planned first study dose.
  • Before your cancer spread, you received oxaliplatin and a fluoropyrimidine before or after surgery, and the cancer worsened within 6 months. The listing excludes this because you did not receive BEV.
  • You have cancer in the brain that causes symptoms or is not controlled, pressure on the spinal cord, or cancer in the lining around the brain and spinal cord that needs treatment at the same time.
  • You have uncontrolled stomach or bowel disease that causes symptoms, uncontrolled high blood pressure, or major heart electrical test (ECG) changes that matter to your health.
  • You are pregnant, breastfeeding, or plan to become pregnant during the study or for at least 6 months after the last study chemotherapy dose.
  • You are a man who plans to father a child during the study or for at least 6 months after the last study chemotherapy dose.
  • You had another active cancer that grows into nearby tissue within the 5 years before screening.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: * Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v1. * Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600 * Participants must have received first-line therapy for mCRC that included oxaliplatin, a fluoropyrimidine, and a BEV-based agent. FOLFOXIRI, BEV, and SOX/BEV regimes are not permitted. A minimum of 2 cycles of first line of therapy must have been completed. * At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF) * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2 Key Exclusion Criteria: * Current treatment with other anticancer treatments within 21 days of the first dose of study treatment * Major surgery within 4 weeks of the first planned dose of study treatment * More than one prior systemic treatment for mCRC or any prior systemic treatment including FOLFIRI or irinotecan-based therapy. * Participants who received oxaliplatin and fluoropyrimidine in the first line neoadjuvant or adjuvant setting (prior to Metastatic diagnosis) and progressed within 6 months are not eligible due to lack of BEV exposure. * Uncontrolled, symptomatic brain metastases * Uncontrolled, symptomatic gastrointestinal disease * Participants with uncontrolled hypertension * Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 6 months after the last administration of study chemotherapy * Men who plan to father a child while in the study and for at least 6 months after the last administration of study chemotherapy * Documented major electrocardiogram (ECG) abnormalities which are clinically significant. * Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment * Presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening

Study sites (14)

CO

IL

MD

MN

MO

OR

PA

TN

TX

VA