Can a targeted drug shrink tumors when only some cells carry the mutation?
NCT ID NCT04034173
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether adding panitumumab to standard chemotherapy can shrink tumors in people with metastatic colorectal cancer that has low-frequency RAS mutations. The idea is that even if a small number of cancer cells have the mutation, most cells may still respond to the drug. Researchers will measure how many patients see their tumors shrink and how long they live without the disease progressing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Panitumumab combined with irinotecan, folinic acid, and 5-FU chemotherapy
- What this could lead to
- If it works, this could offer a treatment option for people with metastatic colorectal cancer who have low-frequency RAS mutations, potentially improving response rates.
- What could go wrong
- This is a small, early-phase trial. The benefit may be short-lived because resistant cancer cells could grow back quickly, and the treatment may not improve overall survival.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
3 people
The number who actually took part.
- Started
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Jul 2019
- Finished
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Jun 2021
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed, UICC stage IV metastatic adenocarcinoma of the colon or rectum * Primarily non-resectable metastases or surgical resection refused by the patient * RAS mutation determined by the local pathology * Age ≥18 * ECOG performance status 0-2 * Patients suitable for chemotherapy administration * Patient's written declaration of consent obtained * Estimated life expectancy \> 3 months * Presence of at least one measurable reference lesion according to the RECIST 1.1 criteria * Primary tumor tissue available and patient consents to storage and molecular and genetic profiling of tumor material. Molecular profiling of blood samples is optionally performed. * Adequate bone marrow function: * Leukocytes ≥ 3.0 x 109/L with neutrophils ≥ 1.5 x 109/L * Thrombocytes ≥ 100 x 109/L * Haemoglobin ≥ 5.6 mmol/L (equivalent to 9 g/dL) * Adequate hepatic function: * Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) * ALAT and ASAT ≤ 2.5 x ULN (in the presence of hepatic metastases, ALAT and ASAT ≤ 5 x ULN) * Adequate renal function: ▫ Creatinine clearance (calculated according to Cockcroft and Gault) ≥ 50 mL/min * No previous chemotherapy for metastatic disease. Patient with need of immediate treatment (high tumor load, symptoms) may have received one application of FOLFIRI prior to study treatment. Exclusion Criteria: * Previous chemotherapy for metastatic disease with the exception of one cycle of FOLFIRI (e.g. while waiting for the result of RAS mutation frequency). * Patients planned to be treated with FOLFOX or another oxaliplatin-based regimen as first-line treatment * Primarily resectable metastases and the patient agrees to resection * Grade III or IV heart failure (NYHA classification) * Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study * Previous chemotherapy for the colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before entering the study * Participation in an investigational clinical study or experimental drug treatment within 30 days prior to study inclusion or within a period of 5 half-lives of the substances administered in the investigational clinical study or during an experimental drug treatment prior to inclusion in the study, depending on which period is longest * Known hypersensitivity or allergic reaction to any of the following substances: 5-fluorouracil, folinic acid, panitumumab, irinotecan, and chemically related substances and/or hypersensitivity to any of the excipients of any of the aforementioned substances including known hypersensitivity reactions to monoclonal antibodies NCI CTCAE Grade ≥ 3. * Known hypersensitivity to Chinese hamster ovary cell (CHO) - cellular products or other recombinant human or humanised monoclonal antibodies * History of uncontrolled bronchial asthma * Patients with interstitial pneumonitis or pulmonary fibrosis * Patients with known brain metastasis * History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea * Symptomatic peritoneal carcinomatosis * Severe, non-healing wounds, ulcers or bone fractures * Patients with acute or chronic infection requiring systemic therapy * Known history of positive testing for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) * Active or chronic Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive; serologic tests required in patients who receive study treatment). * Known DPD deficiency (specific screening not required) * Known glucuronidation deficiency (Gilbert's syndrome);(specific screening not required * Treatment with sorivudine or brivudine within 28 days before study enrollment or requirement for concomitant antiviral treatment with sorivudine or brivudine * History of a second primary malignancy during the past 5 years before inclusion in the study or during participation in the study, with the exception of a basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ, if these were treated curatively. * Known previous or ongoing alcohol or drug abuse * Pregnant or breast-feeding patients * Any other severe concomitant disease or disorder which, in the investigator's opinion, could influence the patient's ability to participate in the study or influence his/her safety during the study or interfere with interpretation of study results * Both, absent and restricted legal capacity
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ludwigs Maximialians University
Munich, 81377, Germany
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