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Cancer Metabolism Inhibitor

ABTL0812 + FOLFIRINOX for Pancreatic Cancer (PanC-ASAP Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Ability Pharmaceuticals SL
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 guidelines with at least one 'target lesion' to be used to assess response. Tumors within a previously irradiated field will be designated as 'non-target' lesions unless progression is documented
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

PanC-ASAP Trial Summary

This trial is testing a new combination cancer treatment to see if it is effective and safe for people with metastatic pancreatic cancer.

Who is the study for?
Adults with confirmed metastatic pancreatic cancer, good blood counts and organ function, who haven't been treated with PI3K/Akt/mTOR pathway inhibitors. They must not have other serious medical conditions or a history of certain heart diseases. Participants need to use effective contraception and be able to follow the study protocol.Check my eligibility
What is being tested?
The trial is testing ABTL0812 in combination with FOLFIRINOX chemotherapy as a first-line treatment for metastatic pancreatic cancer. It's an open-label Phase I followed by a randomized Phase II study comparing this combination against placebo plus FOLFIRINOX.See study design
What are the potential side effects?
Potential side effects may include typical chemotherapy-related issues like nausea, fatigue, lowered blood cell counts leading to increased infection risk, liver enzyme changes, diarrhea or allergic reactions. Specific side effects of ABTL0812 are not detailed but could align with common drug class effects.

PanC-ASAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least one tumor that can be measured and tracked for treatment response.
Select...
I am fully active or can carry out light work.
Select...
I am older than 18 years.
Select...
My blood counts meet the required levels without needing transfusions.
Select...
My cancer has spread to other parts of my body.
Select...
I am using two effective forms of birth control during and 6 months after the study.
Select...
My cancer is a confirmed type of pancreatic cancer.

PanC-ASAP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase I - RP2D
Phase II - PFS
Secondary outcome measures
Adverse events
DOR
ORR
+5 more
Other outcome measures
PK - AUC
PK - Cmax
Quality of Life Questionnaire QLC-C30
+1 more

Side effects data

From 2022 Phase 3 trial • 528 Patients • NCT03504423
75%
Nausea
67%
Diarrhoea
59%
Fatigue
46%
Anaemia
43%
Decreased appetite
41%
Vomiting
41%
Neuropathy peripheral
37%
Hypokalaemia
37%
Constipation
35%
Abdominal pain
34%
Weight decreased
31%
Platelet count decreased
28%
Neutrophil count decreased
27%
Blood alkaline phosphatase increased
23%
Alanine aminotransferase increased
22%
Aspartate aminotransferase increased
21%
Hypoalbuminaemia
21%
Alopecia
21%
Peripheral sensory neuropathy
20%
Hyponatraemia
20%
Dysgeusia
20%
Stomatitis
19%
Neutropenia
19%
Dizziness
18%
Hypomagnesaemia
17%
Hypertension
17%
Oedema peripheral
17%
Back pain
16%
Hypophosphataemia
15%
White blood cell count decreased
15%
Pyrexia
15%
Dehydration
14%
Insomnia
14%
Lymphocyte count decreased
13%
Paraesthesia
13%
Asthenia
13%
Thrombocytopenia
13%
Hyperglycaemia
12%
Dyspepsia
12%
Hypocalcaemia
12%
Cough
12%
Temperature intolerance
11%
Dyspnoea
10%
Anxiety
10%
Mucosal inflammation
10%
Abdominal distension
9%
Activated partial thromboplastin time prolonged
9%
Gastrooesophageal reflux disease
9%
International normalised ratio increased
9%
Headache
9%
Hiccups
9%
Hypotension
8%
Epistaxis
8%
Pulmonary embolism
8%
Flatulence
8%
Abdominal pain upper
8%
Rash
7%
Dry mouth
7%
Depression
7%
Dry skin
7%
Arthralgia
7%
Rhinorrhoea
6%
Myalgia
6%
Infusion related reaction
6%
Non-cardiac chest pain
6%
Blood bilirubin increased
6%
Palmar-plantar erythrodysaesthesia
6%
Ascites
6%
Chills
6%
Pruritus
6%
Deep vein thrombosis
6%
Muscular weakness
5%
Fall
5%
Sinus tachycardia
5%
Embolism
5%
Cholinergic syndrome
4%
Hyperhidrosis
4%
Weight increased
4%
Sepsis
4%
Dysphagia
4%
Haematochezia
4%
Haemorrhoids
4%
Hyperkalaemia
4%
Hypoglycaemia
4%
Pain in extremity
4%
Syncope
4%
Vision blurred
4%
blood creatinine increased
4%
Hypertensive crisis
4%
Oropharyngeal pain
4%
Muscle spasms
3%
Hypernatraemia
3%
Contusion
3%
Hyperbilirubinaemia
3%
Rhinitis allergic
3%
Flushing
3%
Febrile neutropenia
3%
Leukocytosis
3%
Tachycardia
3%
Oral pain
3%
General physical health deterioration
3%
Upper respiratory tract infection
3%
Urinary tract infection
3%
Musculoskeletal pain
3%
Dysphonia
3%
Candida infection
3%
Rhinitis
3%
Diabetes mellitus
3%
Abdominal discomfort
3%
Colitis
3%
Pneumonia
3%
Flank pain
3%
Night sweats
2%
Acute kidney injury
2%
Urinary retention
2%
Hypoaesthesia
2%
Urinary incontinence
2%
Dysarthria
2%
Polyneuropathy
2%
Bacteraemia
2%
Hypermagnesaemia
2%
Hyperphosphataemia
2%
Neck pain
2%
Dysaesthesia
2%
Oral candidiasis
2%
Oral herpes
2%
Electrocardiogram QT prolonged
2%
Upper gastrointestinal haemorrhage
2%
Device related infection
2%
Septic shock
2%
Atrial fibrillation
2%
Bradycardia
2%
Sinus bradycardia
2%
Visual impairment
2%
Gastrointestinal haemorrhage
2%
Oesophagitis
2%
Catheter site pain
2%
Pain
2%
Peripheral swelling
2%
Bile duct obstruction
2%
Immune system disorders
2%
Influenza
2%
Oral fungal infection
2%
Neutrophil count increased
2%
Pancreatic enzymes decreased
2%
White blood cell count increased
2%
Disturbance in attention
2%
Pollakiuria
2%
Nasal congestion
2%
Pleural effusion
2%
Rash maculo-papular
2%
Skin hyperpigmentation
2%
Palpitations
2%
Gastritis
2%
Cholecystitis
2%
Cholestasis
2%
Gamma-glutamyltransferase increased
2%
Lymphocyte count increased
2%
Malnutrition
2%
Musculoskeletal chest pain
2%
Memory impairment
2%
Tremor
2%
Dysuria
2%
Erythema
2%
Rectal haemorrhage
2%
Abdominal pain lower
2%
Eructation
2%
Paraesthesia oral
2%
Proctalgia
2%
Localised oedema
2%
Micturition urgency
2%
Proteinuria
2%
Rash papular
2%
Catheter site infection
2%
Corona virus infection
2%
blood phosphorus decreased
2%
Bone pain
2%
Throat irritation
2%
Thrombophlebitis
1%
Procedural pain
1%
Urinary tract pain
1%
Tooth fracture
1%
Hypertriglyceridaemia
1%
Erythema multiforme
1%
Stress cardiomyopathy
1%
Duodenal obstruction
1%
Ligament sprain
1%
Chromaturia
1%
Nail discolouration
1%
Hepatocellular injury
1%
Presyncope
1%
Scab
1%
Venous thrombosis
1%
Acute left ventricular failure
1%
Intestinal obstruction
1%
Pancreatitis
1%
Small intestinal obstruction
1%
Biliary tract infection
1%
Diabetic ketoacidosis
1%
Mental status changes
1%
Leukopenia
1%
Lymphadenopathy
1%
Ventricular extrasystoles
1%
Dry eye
1%
Photophobia
1%
Enteritis
1%
Enterocolitis
1%
Gingival pain
1%
Haemorrhoidal haemorrhage
1%
Large intestine perforation
1%
Melaena
1%
Mouth ulceration
1%
Obstruction gastric
1%
Odynophagia
1%
Salivary hypersecretion
1%
Chest discomfort
1%
Feeling cold
1%
Gait disturbance
1%
Generalised oedema
1%
Malaise
1%
Oedema
1%
Biliary dilatation
1%
Gallbladder obstruction
1%
Ischaemic hepatitis
1%
Abscess
1%
Herpes simplex
1%
Pharyngitis
1%
Rash pustular
1%
Sinusitis
1%
Blood bilirubin decreased
1%
blood magnesium decreased
1%
Cardiac murmur
1%
Heart rate increased
1%
Protein total decreased
1%
Tumour pain
1%
Aphasia
1%
Ataxia
1%
Cerebrovascular accident
1%
Dizziness postural
1%
Device malfunction
1%
Device occlusion
1%
Agitation
1%
Confusional state
1%
Restlessness
1%
Haematuria
1%
Nocturia
1%
Atelectasis
1%
Dyspnoea exertional
1%
Laryngeal inflammation
1%
Pharyngeal inflammation
1%
Pneumonitis
1%
Productive cough
1%
Upper-airway cough syndrome
1%
Rash erythematous
1%
Skin discolouration
1%
Urticaria
1%
Pancytopenia
1%
Neurotoxicity
1%
Lacrimation increased
1%
Ocular hyperaemia
1%
Faeces pale
1%
Jaundice cholestatic
1%
Gastrointestinal pain
1%
Glossodynia
1%
Haematemesis
1%
Lip ulceration
1%
Lower gastrointestinal haemorrhage
1%
Toothache
1%
Device related thrombosis
1%
Early satiety
1%
Cholangitis
1%
Cholangitis acute
1%
Drug hypersensitivity
1%
Gastroenteritis
1%
Vulvovaginal mycotic infection
1%
Post procedural complication
1%
Thermal burn
1%
blood cholesterol increased
1%
Blood sodium decreased
1%
Hepatic enzyme increased
1%
Prothrombin time prolonged
1%
Transaminases increased
1%
Glucose tolerance impaired
1%
Hypercalcaemia
1%
Type 2 diabetes mellitus
1%
Fistula
1%
Encephalopathy
1%
Dermatitis acneiform
1%
Peroneal nerve palsy
1%
Hypoxia
1%
Nasal dryness
1%
Gout
1%
Blood creatinine increased
1%
Pancreatic failure
1%
Steatorrhoea
1%
Eye pain
1%
Abdominal hernia
1%
Abnormal faeces
1%
Aphthous ulcer
1%
Swelling
1%
Herpes zoster
1%
Limb injury
1%
Blood albumin decreased
1%
Speech disorder
1%
Renal failure
1%
Pelvic pain
1%
Decubitus ulcer
1%
Dyshidrotic eczema
1%
Ecchymosis
1%
Hypersensitivity
1%
Cellulitis
1%
Clostridium difficile colitis
1%
Clostridium difficile infection
1%
Joint swelling
1%
Muscle twitching
1%
Sneezing
1%
Orthostatic hypotension
1%
Pallor
1%
Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
CPI-613, mFolfirinox
Folfirinox

PanC-ASAP Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B) PLACEBO + FOLFIRINOXExperimental Treatment2 Interventions
FOLFIRINOX will be dosed according to the standard following regimen: oxaliplatin 85 mg/m2, administered as 2-hour iv infusion leucovorin 400 mg/m2, administered as 2-hour iv infusion irinotecan 180 mg/m2, administered as 1.5-hour iv infusion fluorouracil 2400 mg/m2, administered as 46-hour iv infusion every 2 weeks (=1 cycle) until disease progression or unacceptable toxicities. Placebo will be administered at the same volume than ABTL0812 in arm A) FOLFIRINOX, then daily during chemotherapy cycles. Also, placebo will be maintained once chemotherapy is discontinued.
Group II: Arm A) ABTL0812 + FOLFIRINOXExperimental Treatment2 Interventions
FOLFIRINOX will be dosed according to the standard following regimen: oxaliplatin 85 mg/m2, administered as 2-hour iv infusion leucovorin 400 mg/m2, administered as 2-hour iv infusion irinotecan 180 mg/m2, administered as 1.5-hour iv infusion fluorouracil 2400 mg/m2, administered as 46-hour iv infusion every 2 weeks (=1 cycle) until disease progression or unacceptable toxicities. ABTL0812 will be administered daily at its RP2D. ABTL0812 will be administered as single agent during a run-in period of one week before starting the first cycle of FOLFIRINOX, then daily during chemotherapy cycles. Also, ABTL0812 will be maintained once chemotherapy is discontinued, if ABTL0812 is tolerated and if the patient is in response or stable disease.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Folfirinox
2018
Completed Phase 3
~610
ABTL0812
2014
Completed Phase 1
~30
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Ability Pharmaceuticals SLLead Sponsor
3 Previous Clinical Trials
190 Total Patients Enrolled
Marc CortalStudy DirectorAbility Pharmaceuticals SL

Media Library

ABTL0812 (Cancer Metabolism Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04431258 — Phase 1 & 2
Pancreatic Cancer Research Study Groups: Arm B) PLACEBO + FOLFIRINOX, Arm A) ABTL0812 + FOLFIRINOX
Pancreatic Cancer Clinical Trial 2023: ABTL0812 Highlights & Side Effects. Trial Name: NCT04431258 — Phase 1 & 2
ABTL0812 (Cancer Metabolism Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04431258 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still space available for volunteers to partake in this research?

"Clinicaltrials.gov confirms that this medical trial, which has been in existence since May 6th 2021, is still looking for candidates and was last updated on November 8th 2022."

Answered by AI

Is the participation in this experiment restricted to seniors, or are those younger than 65 able to join?

"According to the criteria for participation, individuals aged 18-80 are eligible. For those under 18 and over 65 there are 5 and 391 clinical trials available respectively."

Answered by AI

What prior research has encompassed the compound ABTL0812?

"At this moment, two studies are investigating the efficacy of ABTL0812. None of these research projects have reached Phase 3 yet. Furthermore, 14 distinct medical sites across Murcia and Galicia are conducting trials with this medication."

Answered by AI

What are the key aims of this clinical investigation?

"This 6-month study seeks to establish the maximum tolerated dose of this medication, which is referred to as RP2D. The primary outcomes considered are Adverse Events categorised by CTCAE v5.0 and Overall Survival (OS 1y), while PFS using RECIST v1.1 will be collected for investigator analysis."

Answered by AI

Is this an unprecedented research project?

"ABTL0812 has been studied since 2020, beginning with Ability Pharmaceuticals SL's Phase 1 & 2 trial. From there, two active studies were conducted in 5 cities across 3 nations and ABTL0812 received its drug approval."

Answered by AI

How many participants are currently receiving treatment as part of this experiment?

"In order for this medical trial to be successful, 150 qualified participants are needed. Those interested can join from University of Cincinnati in Ohio or University of Kansas Cancer Center in Westwood, Kansas."

Answered by AI

For whom is enrollment in this experiment permissible?

"This research endeavour seeks 150 individuals aged between 18-80 that have been diagnosed with malignant neoplasm of the pancreas. Additionally, participants must meet other criteria such as ECOG Performance Status 0-1, platelet count ≥ 100x109/L without transfusion support, hemoglobin ≥ 10 g/dL, measurable disease per RECIST Version 1.1 guidelines with at least one target lesion to evaluate response and more conditions for consideration in this study."

Answered by AI
~29 spots leftby Dec 2024