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Anti-metabolites

LCL161 + Chemotherapy for Pancreatic Cancer

Phase 1
Waitlist Available
Led By Yvonne M. Coyle, 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
Must not have
Patient is currently receiving chronic (> 14 days) treatment with corticosteroids at a dose ≥ 10 mg of prednisone (or its glucocorticoid equivalent) per day, or any other chronic immunosuppressive treatment that cannot be discontinued prior to starting study drug
Patient is a woman of child-bearing potential, defined as all women physiologically capable of becoming pregnant and refusing to use highly effective methods of contraception during dosing and for 90 days after study treatment. Highly effective contraception methods include: Total abstinence, male partner or female sterilization, combination of any 2 of the following (a+b or a+c, or b+c): Use of oral, injected, or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods of contraception: condom for male partner or occlusive cap (diaphragm or cervical/vault caps) with spermicidal form/gel/film/cream/ vaginal suppository. Note: Postmenopausal women are allowed to participate in this study. Women are considered postmenopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (eg, age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks earlier. In the case of oophorectomy alone, a woman is considered to be not of child bearing potential only when her reproductive status has been confirmed by follow-up hormone level assessment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.6 years
Awards & highlights

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.
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.
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 below
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My pancreatic cancer is at stage IV and can be measured by CT scans.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I can swallow and keep down pills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on long-term steroids or other immune-weakening drugs that I can't stop.
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I am a woman who can become pregnant and agree to use effective birth control during the study.
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I have a history of lymphoma, treated or untreated.
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I have had interstitial pneumonitis.
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I am a male and will use a condom during the study and for 3 months after.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose of LCL161
Percentage of patients with Dose-Limiting Toxicities
Secondary study objectives
Objective Response Rate

Side effects data

From 2014 Phase 2 trial • 209 Patients • NCT01617668
72%
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%
Pneumocystis jirovecii pneumonia
4%
Pneumonia
3%
Atypical pneumonia
3%
Hypertension
2%
Hypotension
2%
Hypoaesthesia
2%
Pulmonary embolism
2%
Hyponatraemia
1%
Febrile neutropenia
1%
Anaphylactic reaction
1%
Anaphylactic shock
1%
Cytokine release syndrome
1%
Infection
1%
Lower respiratory tract infection
1%
Blood creatinine increased
1%
Interstitial lung disease
1%
Pleural effusion
1%
Dermatitis
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
2,889 Previous Clinical Trials
4,201,980 Total Patients Enrolled
Delta Clinical Research, LLCIndustry Sponsor

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT01934634 — Phase 1
Pancreatic Cancer Research Study Groups: LCL161 +Gemcitabine +nab-Paclitaxel
Pancreatic Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT01934634 — Phase 1
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01934634 — Phase 1
~2 spots leftby Sep 2025
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