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Monoclonal Antibodies
MEN1611 + Cetuximab for Colorectal Cancer (C-PRECISE-01 Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by Menarini Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
N-K-RAS (exons 2, 3 and 4) and BRAF wild-type and PIK3CA mutated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
C-PRECISE-01 Trial Summary
This trial is testing a new drug, MEN1611, to see if it is effective and safe to treat patients with metastatic colorectal cancer.
Who is the study for?
This trial is for adults with metastatic colorectal cancer that has progressed after treatment with certain chemotherapy and anti-EGFR drugs. Participants must have a specific gene mutation (PIK3CA), no prior PI3K inhibitor treatments, stable heart and lung function, controlled diabetes, and no active severe infections or brain metastases.Check my eligibility
What is being tested?
The study is testing the combination of MEN1611, a new drug, with Cetuximab in patients whose tumors have a particular genetic change. It's an open-label Phase Ib/II trial which means everyone gets the experimental treatment and researchers track its effectiveness and safety.See study design
What are the potential side effects?
Potential side effects may include reactions to medication infusions, gastrointestinal issues like diarrhea, changes in blood sugar levels or blood pressure, skin reactions due to Cetuximab, fatigue, and increased risk of infection.
C-PRECISE-01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
My cancer is N-K-RAS and BRAF wild-type but has a PIK3CA mutation.
Select...
My cancer returned or worsened after treatment with specific chemotherapy drugs.
Select...
My last cancer treatment with anti-EGFR showed partial improvement or stability for 4+ months.
Select...
My cancer is a type of colon or rectal cancer.
C-PRECISE-01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best overall response rate (ORR) according to RECIST v.1.1
Determination of recommended phase II dose (RP2D)
Secondary outcome measures
Therapeutic procedure
Side effects data
From 2013 Phase 2 trial • 86 Patients • NCT0125638575%
Fatigue
65%
Anemia
48%
Hyperglycemia
43%
Lymphocyte count decreased
38%
Anorexia
35%
Platelet count decreased
35%
Constipation
35%
Cough
35%
Nausea
30%
Pain
30%
Mucositis oral
28%
Dyspnea
28%
White blood cell decreased
28%
Hypoalbuminemia
25%
Alanine aminotransferase increased
25%
Cholesterol high
25%
Hypertriglyceridemia
23%
Dysphagia
20%
Depression
20%
Fever
20%
Hypophosphatemia
20%
Weight loss
18%
Non-cardiac chest pain
18%
Alkaline phosphatase increased
18%
Aspartate aminotransferase increased
18%
Insomnia
18%
Headache
18%
Hyponatremia
18%
Hypocalcemia
18%
Hypokalemia
15%
Edema face
15%
Vomiting
15%
Creatinine increased
15%
Neck pain
15%
Peripheral sensory neuropathy
13%
Infections and infestations - Other
13%
Diarrhea
13%
Dysgeusia
13%
Rash acneiform
13%
Rash maculo-papular
10%
Neutrophil count decreased
10%
Dizziness
10%
Arthralgia
10%
Edema limbs
8%
Anxiety
8%
Oral dysesthesia
8%
Respiratory failure
8%
Pneumonitis
8%
Pruritus
8%
Facial pain
8%
Back pain
8%
Dry mouth
8%
Dry skin
8%
Hypertension
8%
INR increased
8%
Neck edema
5%
Allergic rhinitis
5%
Pleural effusion
5%
General disorders and administration site conditions - Other
5%
Hypernatremia
5%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
5%
Skin infection
5%
Dyspepsia
5%
Ear pain
5%
Epistaxis
5%
Gastroesophageal reflux disease
5%
Generalized muscle weakness
5%
Hypomagnesemia
5%
Leukocytosis
5%
Lung infection
5%
Lymphedema
5%
Sore throat
5%
Tumor pain
5%
Urinary frequency
5%
Hearing impaired
5%
Sinusitis
5%
Chills
5%
Dehydration
5%
Hypercalcemia
5%
Hyperkalemia
5%
Myalgia
5%
Papulopustular rash
3%
Tracheostomy site bleeding
3%
Vertigo
3%
Alopecia
3%
Oral pain
3%
Pharyngeal hemorrhage
3%
Laryngeal obstruction
3%
Anorectal infection
3%
Hypoxia
3%
Pleural infection
3%
Pleuritic pain
3%
Pneumothorax
3%
Respiratory, thoracic and mediastinal disorders - Other
3%
Stridor
3%
Postnasal drip
3%
Skin and subcutaneous tissue disorders - Other
3%
Skin ulceration
3%
Eye disorders - Other
3%
Heart failure
3%
Tracheal hemorrhage
3%
Blurred vision
3%
Hypotension
3%
Palmar-plantar erythrodysesthesia syndrome
3%
Peripheral motor neuropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Temsirolimus)
Arm A (Cetuximab and Temsirolimus)
C-PRECISE-01 Trial Design
1Treatment groups
Experimental Treatment
Group I: MEN1611Experimental Treatment2 Interventions
MEN1611 + Cetuximab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
2011
Completed Phase 3
~2480
Find a Location
Who is running the clinical trial?
Menarini GroupLead Sponsor
42 Previous Clinical Trials
11,797 Total Patients Enrolled
Josep Tabernero, MD PhDStudy ChairVall d' Hebron Institute of Oncology (VHIO), Barcelona, Spain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with a PI3K inhibitor before.My diabetes is not under control, with high HbA1c and fasting glucose levels.I am fully active or can carry out light work.My cancer is N-K-RAS and BRAF wild-type but has a PIK3CA mutation.My cancer returned or worsened after treatment with specific chemotherapy drugs.My brain metastases were treated over 4 weeks ago, are stable, and I'm not on steroids.I have a history of HIV or active hepatitis B or C.My last cancer treatment with anti-EGFR showed partial improvement or stability for 4+ months.I have a history of serious heart problems that are not under control.I have ongoing lung problems that are not under control.My cancer is a type of colon or rectal cancer.I have moderate to severe diarrhea.I am currently on long-term steroids or other drugs that weaken my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: MEN1611
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent has MEN1611 been explored in medical research?
"The MEN1611 study was initiated at Royal Bournemouth Hospital in 2007, and has since had 372 completed trials. There are presently 121 studies actively seeking participants with a significant proportion of these occurring in Tacoma, Washington."
Answered by AI
Are there vacancies available for those interested in participating in this experiment?
"Per the information on clinicaltrials.gov, recruitment is still in progress for this trial which was first published July 20th 2020 and subsequently modified February 14th 2022."
Answered by AI
How many participants are being enrolled for this clinical trial?
"Menarini Group, the protocol sponsor for this clinical trial, is seeking 42 participants that meet the inclusion criteria to participate in the study. The sites of operation include MultiCare Health System Institute for Research and Innovation located in Tacoma, Washington as well as The Oncology Institute of Hope and Innovation found in Anaheim, California."
Answered by AI
In what medical situations is MEN1611 typically utilized?
"MEN1611 is widely prescribed for pharmacotherapy, but can also be utilized to manage regionally advanced squamous cell carcinoma of the head and neck, metastatic hnscc (Head and Neck Squamous Cell Carcinoma), as well as general squamous cell carcinoma."
Answered by AI
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