Your session is about to expire
← Back to Search
Anti-metabolites
LCL161 + Chemotherapy for Pancreatic Cancer
Phase 1
Waitlist Available
Led By Carlos H. Becerra, MD
Research Sponsored by US Oncology Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically documented measureable metastatic (Stage IV) pancreatic cancer with disease by computed tomography scan as defined by RECIST Version 1.1
Age 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.6 years
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see what dose is safe and how well it works with other existing cancer drugs.
Who is the study for?
Adults with measurable metastatic pancreatic cancer who haven't had Stage IV treatment can join. They must be able to take oral meds, have certain blood and organ function levels, and not have severe medical conditions or heart issues. Pregnant women, those on specific drugs, or with GI absorption problems are excluded.Check my eligibility
What is being tested?
The trial is testing the highest dose of LCL161 that patients can tolerate when given with gemcitabine and nab-paclitaxel for metastatic pancreatic cancer. It aims to find out what side effects occur at this maximum dose.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system's response to the drug combination, potential impact on blood counts and liver function tests due to chemotherapy agents like gemcitabine and nab-paclitaxel.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pancreatic cancer is at stage IV and can be measured by CT scans.
Select...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
Select...
I can swallow and keep down pills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1.6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose of LCL161
Percentage of patients with Dose-Limiting Toxicities
Secondary outcome measures
Objective Response Rate
Side effects data
From 2014 Phase 2 trial • 209 Patients • NCT0161766872%
Diarrhoea
68%
Alopecia
45%
Fatigue
42%
Pyrexia
42%
Rash
42%
Nausea
33%
Headache
31%
Neutropenia
28%
Cough
26%
Pruritus
25%
Anaemia
25%
Stomatitis
24%
Peripheral sensory neuropathy
23%
Dysgeusia
23%
Dyspnoea
23%
Constipation
22%
Myalgia
21%
Insomnia
20%
Vomiting
20%
Arthralgia
16%
Hot flush
15%
Asthenia
15%
Oropharyngeal pain
14%
Alanine aminotransferase increased
14%
Epistaxis
12%
Neuropathy peripheral
12%
Aspartate aminotransferase increased
11%
Decreased appetite
11%
Dizziness
11%
Dyspepsia
11%
Oedema peripheral
11%
Chills
10%
Musculoskeletal pain
10%
Pain in extremity
10%
Abdominal pain
10%
Neurotoxicity
9%
Dry mouth
9%
Back pain
9%
Neutrophil count decreased
9%
Pneumonitis
9%
Urinary tract infection
9%
Erythema
8%
Haemoglobin decreased
8%
Paraesthesia
8%
Drug hypersensitivity
8%
White blood cell count decreased
8%
Breast pain
8%
Palmar-Plantar erythrodysaesthesia syndrome
8%
Anxiety
7%
Vision blurred
7%
Procedural pain
7%
Abdominal pain upper
7%
Hypersensitivity
6%
Influenza like illness
6%
Flushing
6%
Hyperglycaemia
5%
Nail disorder
4%
Pneumonia
4%
Pneumocystis jirovecii pneumonia
3%
Atypical pneumonia
3%
Hypertension
2%
Hypoaesthesia
2%
Hypotension
2%
Pulmonary embolism
2%
Hyponatraemia
1%
Pleural effusion
1%
Anaphylactic reaction
1%
Cytokine release syndrome
1%
Febrile neutropenia
1%
Interstitial lung disease
1%
Dermatitis
1%
Anaphylactic shock
1%
Blood creatinine increased
1%
Infection
1%
Lower respiratory tract infection
1%
Lymph node pain
1%
Disseminated intravascular coagulation
1%
Feeling cold
1%
Febrile infection
1%
Herpes zoster
1%
Sinus tachycardia
1%
Polyarthritis
1%
Hyperkalaemia
1%
Immobile
1%
Respiratory failure
1%
Depression
1%
Pneumothorax
1%
Hypoxia
1%
Acute kidney injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
LCL161+PACLITAXEL
PACLITAXEL
Trial Design
1Treatment groups
Experimental Treatment
Group I: LCL161 +Gemcitabine +nab-PaclitaxelExperimental Treatment3 Interventions
LCL161 (tablets): 600, 1200, or 1800 mg once a week (Day 1, 8, 15) for 3 weeks, every 28 days Gemcitabine IV: 1,000 mg/m2 once a week (Day 1, 8, 15) for 3 weeks, every 28 days nab-paclitaxel IV: 100 or 125 mg/m2 once a week (Day 1, 8, 15) for 3 weeks, every 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LCL-161
Not yet FDA approved
Gemcitabine
FDA approved
Paclitaxel
FDA approved
Find a Location
Who is running the clinical trial?
US Oncology ResearchLead Sponsor
37 Previous Clinical Trials
17,438 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,855 Previous Clinical Trials
4,197,326 Total Patients Enrolled
Delta Clinical Research, LLCIndustry Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Before joining the trial, you need to have specific blood test results within certain ranges. You must not have received previous treatment for Stage IV pancreatic cancer, except for specific types of previous treatment.I have a heart condition but it's stable and doesn't include severe arrhythmias.I am on long-term steroids or other immune-weakening drugs that I can't stop.You are pregnant or breastfeeding.My pancreatic cancer is at stage IV and can be measured by CT scans.I have a history of lymphoma, treated or untreated.I have had interstitial pneumonitis.I am 18 years old or older.I am on medication that interacts with specific liver enzymes or affects heart rhythm.I have a stomach or intestine condition that affects how my body absorbs medication.I am a woman who can become pregnant and agree to use effective birth control during the study.I have given my written consent for the screening tests.I am fully active or can carry out light work.I am a male and will use a condom during the study and for 3 months after.I can swallow and keep down pills.
Research Study Groups:
This trial has the following groups:- Group 1: LCL161 +Gemcitabine +nab-Paclitaxel
Awards:
This trial has 2 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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.
What is the regulatory status of LCL161?
"Our evaluation team at Power assessed the safety of LCL161 as a 1 because it is currently in Phase 1 clinical trials, where limited data exists concerning its efficacy and safety."
Answered by AI
How many participants have so far joined this research project?
"This study is no longer recruiting participants. It was initially uploaded in March 2014 and the last update occurred on November 2015. For those searching for alternative trials, there are currently 587 clinical studies accommodating people with pancreatic metastatic cancer and 1114 open investigations involving LCL161."
Answered by AI
What medical disorders is LCL161 typically administered to alleviate?
"LCL161 is a useful medication for managing neoplasm metastasis, and it can also be employed to treat locally advanced non-small cell lung cancer, troublesome bladder cancer, as well as urinary tract issues."
Answered by AI
Are there any historical precedents for using LCL161 in medical studies?
"Presently, 1114 clinical trials are in progress for LCL161. Out of these studies, 321 reside in Phase 3. Even though the majority of research is conducted within Shanghai, there are 59453 other sites running tests with this medication."
Answered by AI
Is there currently an opportunity to participate in this research study?
"According to the data posted on clinicaltrials.gov, this clinical trial is not presently enrolling patients. Initially published in March of 2014 and most recently updated in November 2015, it appears other opportunities exist with 1,701 trials actively recruiting participants as an alternative."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger