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FFCD 1605- OPTIPRIME: A phase II study evaluating FOLFOX + panitumumab according to a ‘stop-and-go’ strategy with a reintroduction loop after progression on fluoropyrimidine as maintenance treatment, as the first line in patients with metastatic colorectal adenocarcinoma without a RAS mutation
EU CTIS ID: 2024-518740-20-00
What this study is testing
Evaluate the disease control duration
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically proven colorectal adenocarcinoma without RAS mutation
- PT > 60%, albumin ≥ 25 g/L
- Life expectancy ≥ 3 months
- Patient affiliated to a social security scheme
- Patient informed and informed consent form signed
- Confirmed, non-resectable metastatic disease (Stage IV)
You likely can't join if
- Presence of brain metastases unless controlled
- Any known specific contraindication or allergy to the medicinal products used in the study (see SmPC Annex 7)
- Association with the yellow fever vaccine
- Patient simultaneously included in another clinical trial involving an investigational drug
- High blood pressure not controlled by medical treatment (PAS > 160 mmHg and/or PAD >90 mmHg)
- Any progressive disease not stabilised over the past 6 months: hepatic failure, renal failure, respiratory failure
See the full eligibility criteria
Who can join
- Histologically proven colorectal adenocarcinoma without RAS mutation
- PT > 60%, albumin ≥ 25 g/L
- Life expectancy ≥ 3 months
- Patient affiliated to a social security scheme
- Patient informed and informed consent form signed
- Confirmed, non-resectable metastatic disease (Stage IV)
- No prior chemotherapy except perioperative or adjuvant chemotherapy discontinued for more than 12 months
- At least one measurable metastasis according to the RECIST v1.1 criteria
- Age ≥ 18 years
- WHO ≤ 2
- Neutrophils > 1,500 /mm3, platelets > 100,000/mm3, Hb > 9 g/dL
- Creatinine clearance > 50 mL/min according to the Cockcroft & Gault formula, 24h proteinuria < 1 g
- Serum bilirubin < 25 µmol/L, AST, ALT, Alk Phos < 2.5 x ULN or < 5 x ULN in case of liver metastases
What rules you out
- Presence of brain metastases unless controlled
- Any known specific contraindication or allergy to the medicinal products used in the study (see SmPC Annex 7)
- Association with the yellow fever vaccine
- Patient simultaneously included in another clinical trial involving an investigational drug
- High blood pressure not controlled by medical treatment (PAS > 160 mmHg and/or PAD >90 mmHg)
- Any progressive disease not stabilised over the past 6 months: hepatic failure, renal failure, respiratory failure
- The following conditions in the 6 months prior to inclusion: myocardial infarction, severe/unstable angina, coronary artery bypass surgery, congestive heart failure NYHA class II, III or IV, stroke or transient ischaemic attack
- Patient who has received a transplant, is seropositive for HIV, hepatitis B or hepatitis C or has other immunodeficiency syndromes
- History of malignant diseases during the past 5 years except basal cell carcinoma of the skin or cervical carcinoma in situ, properly treated
- QT/QTc interval > 450 msec for men and > 470 msec for women
- K+ < LLN, Mg2+ < LLN, Ca2+ < LLN
- RAS mutation (KRAS or NRAS mutation) or BRAF mutation
- Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women, women of childbearing age who have not had a pregnancy test. Women of childbearing potential should agree to use a method of contraception during treatment of the trial and at least 4 months after discontinuation of oxaliplatin therapy, at least 2 months after discontinuation of panitumumab therapy and at least 30 days after discontinuation of 5-fluorouracil or capecitabine. Men must agree to use a method of contraception during treatment and at least 6 months after stopping oxaliplatin therapy and at least 3 months after stopping 5-fluorouracil or capecitabine.
- Persons in custody or under wardship
- Impossibility of undergoing medical monitoring during the trial for geographical, social or psychological reasons
- Patient taking warfarin. If treated with an anticoagulant at the indicated effective dose, this must be replaced with low molecular weight heparin before inclusion
- Partial or complete DihydroPyrimidine Dehydrogenase (DPD) deficiency (defined as uracilemia ≥16 ng/ml)
- Peripheral neuropathy > 1 (NCI CTCAE v4.0)
- Patient with interstitial pneumonitis or pulmonary fibrosis
- History of chronic diarrhoea or inflammatory disease of the colon or rectum, or obstruction or sub-obstruction during symptomatic treatment
- Chronic skin disease poorly controlled
- Treatment with sorivudine or its chemically related analogues such as brivudine
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.