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Tests treatment safety and results for Metastatic Colorectal Cancer (mCRC)
Official title Efficacy And Safety Of Hydroxychloroquine Combined With Methotrexate, Capecitabine And Bevacizumab Vs. Regorafenib In Participants With Refractory Metastatic Colorectal Cancer With Mutations In RAS Genes
ClinicalTrials.gov ID: NCT06949982
What this study is testing
What is experimental group x-MAP?
experimental group x-MAP is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic colorectal cancer (mcrc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate efficacy and safety of hydroxychloroquine combined with methotrexate, capecitabine and bevacizumab versus regorafenib in participants with refractory metastatic colorectal cancer with mutations in KRAS or NRAS genes. The hypotheses of this study are that a combination of hydroxychloroquine, methotrexate, capecitabine, and bevacizumab (compared to regorafenib) prolongs progression-free survival and overall survival, and also increases rates of objective responses and disease control.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Provide written informed consent
- Age ≥ 18 years
- Histologically confirmed diagnosis of colorectal cancer (CRC) with distant metastases.
- Presence of mutations in the KRAS or NRAS gene.
You likely can't join if
- Presence of clinically significant cardiovascular disease: severe or unstable ischemic heart disease, history of myocardial infarction, New York...
- Stroke and/or transient ischemic attack within 6 months prior to screening;
- Uncontrolled hypertension
- History of previous malignancies except non-melanoma skin cancers, or in situ cervical or breast cancer unless a complete remission was achieved at...
- Patients with CNS metastases are eligible only if the metastases are adequately treated.
- Absolute neutrophil count (ANC) \<1.5×109/L, platelet count \<100×109/L, or hemoglobin \<9.0 g/dL.
See the full eligibility criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Provide written informed consent
- Age ≥ 18 years
- Histologically confirmed diagnosis of colorectal cancer (CRC) with distant metastases.
- Presence of mutations in the KRAS or NRAS gene.
- Participants must have previously treated for metastatic colorectal cancer and experienced disease progression during receiving at least 2 lines of systemic chemotherapy in combination with antiangiogenic agents.
- Patient has previously received oxaliplatin- and irinotecan-containing regimens and developed resistance to these chemotherapeutic agents.
- Presence of clinically significant cardiovascular disease: severe or unstable ischemic heart disease, history of myocardial infarction, New York Heart Association Class III/IV congestive heart failure, ventricular...
- Stroke and/or transient ischemic attack within 6 months prior to screening;
- Uncontrolled hypertension
- History of previous malignancies except non-melanoma skin cancers, or in situ cervical or breast cancer unless a complete remission was achieved at least 2 years prior to randomization AND no additional therapy is...
- Patients with CNS metastases are eligible only if the metastases are adequately treated.
- Absolute neutrophil count (ANC) \<1.5×109/L, platelet count \<100×109/L, or hemoglobin \<9.0 g/dL.
- Serum total bilirubin \>1.5 × the upper limit of normal (ULN). Participants with Gilbert syndrome, bilirubin \<2 X ULN, and normal AST/ALT are eligible;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 × ULN;
- Serum creatinine \>1.5 × ULN.
- History of a thromboembolic event
- Presence of any allergic reactions to components of the study drugs
- Concomitant medications with a known risk of causing QT prolongation and/or Torsades de Pointes.
- Any anti-cancer systemic therapy, radiation therapy
- Women who are pregnant or lactating;
- Presence of unresolved adverse events of grade 2 or higher toxicity, according to CTCAE v5.0 criteria, from prior therapy (except for alopecia or neurotoxicity grade≤2).
- Any other serious or uncontrolled medical disorder, active infection, physical examination finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would...
The study team makes the final eligibility decision.
Where it's taking place
- Saint Petersburg, Sankt-Peterburg, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Petersburg, Sankt-Peterburg, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.