Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Irinotecan

Leucovorin

Fluorouracil

Oxaliplatin

Folfirinox

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.

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.

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.

ABTL0812

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 infusionevery 2 weeks (=1 cycle) until disease progression or unacceptable toxicities.

Placebo will be administered daily at the same regim as ABTL0812. Placebo 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, placebo will be maintained once chemotherapy is discontinued, if the patient is in response or stable disease.

Placebo

Marc Cortal

A Phase I open label followed by a Phase II randomized, controlled study to assess the efficacy and safety of ABTL0812 in combination with FOLFIRINOX for first-line treatment of metastatic pancreatic. Funded by: FDA OOPD (Grant #FD-R-006817-01), H2020 EIC Accelerator (Grant #954825) and Ability Pharmaceuticals SL.

Phase I: This is an open label Phase I to determine the RP2D of ABTL0812 in combination with FOLFIRINOX. All patients will receive ABTL0812 in combination with FOLFIRINOX.

A dose de-escalation phase will be performed in which up to 3 different ABTL0812 dose levels will be tested in combination with FOLFIRINOX. ABTL0812 doses are: 1300 mg tid (starting dose), followed (if necessary) by 975 mg tid and 650 mg tid. Patient intra-escalation is not allowed.

Phase II: This is a double blind, randomized, placebo-controlled Phase II multicenter study to evaluate ABTL0812 in combination with FOLFIRINOX for first-line treatment of metastatic pancreatic cancer. Patients will be randomized to one of two groups: arm A) receiving ABTL0812 in addition to FOLFIRINOX and arm B) receiving FOLFIRINOX plus placebo.

Arm A) ABTL0812 + FOLFIRINOX Arm B) PLACEBO + FOLFIRINOX

Double blind, randomized, placebo-controlled, multicenter study

ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic Study

A Phase I Open Label Followed by a Phase II Randomized, Controlled Study to Assess the Efficacy and Safety of ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic

Determination of peak plasma concentration

Determinatoin of Area under the plasma concentration versus time curve

Quality of life measured with questionnaires QLC-C30

Quality of life measured with questionnaires QLQ-PAN26

Recommended Phase II Dose (RP2D) of ABTL0812 in combination with FOLFIRINOX

PFS using RECIST v1.1 by investigator analysis

Number of participants with Adverse Events (AE). AEs classified according to CTCAE v5.0

Ability Pharmaceuticals SL

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antimetabolites

ABTL0812 (starting 1,300 mg tid orally) in combination with gemcitabine and nab-paclitaxel will be administered to patients with pancreatic cancer

Gemcitabine and nab-paclitaxel will be administered to patients with pancreatic cancer as standard pattern

ABTL0812 in combination with gemcitabine and nab-paclitaxel

Gemcitabine and nab-paclitaxel as standard pattern

Gemcitabine and nab-paclitaxel

Carles Domènech, PhD

A Randomized Phase I/II Open Label Study to Assess the Efficacy and Safety of ABTL0812 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Advanced Metastatic Pancreatic Cancer at First Line Therapy.

This is an open-label, randomized phase I/II multicenter study to evaluate ABTL0812 in combination with gemcitabine and nab-paclitaxel at first line therapy. Patients will be assigned to the following groups during the study conduct:

* GROUP A: You will receive the standard treatment of chemotherapy and the investigational drug ABTL0812.
* GROUP B: You will receive the standard treatment of chemotherapy.

For GROUP A:

Phase I: A 3+3 de-escalation design followed by an expansion phase will be performed

* ABTL0812 will be administered chronically daily. Potential dose levels are 1300 mg tid, 1000 mg tid, 650 mg tid and 500 mg tid. Intrapatient escalation or de-escalation is not permitted. A run-in period of one week for ABTL0812 is planned before starting the first cycle of chemotherapy.
* Chemotherapy will be administered on 28-day cycles: gemcitabine 1000 mg/m2 + nab-paclitaxel 125 mg/m2 on days 1, 8 and 15.
* If any, or all, the components of the chemotherapeutic regimen must be interrupted for any reason (excluding disease progression), ABTL0812 will be administered as maintenance therapy until disease progression, onset of unacceptable drug toxicities, or patient/physician's request to discontinue.

Phase II:

* ABTL0812 will be administered chronically daily at the Recommended Phase 2 Dose (RP2D). A run-in period of one week for ABTL0812 is planned before starting the first cycle of chemotherapy.
* Chemotherapy will be administered on 28-day cycles: gemcitabine 1000 mg/m2 IV + nab-paclitaxel 125 mg/m2 IV on days 1, 8 and 15
* If any, or all, the components of the chemotherapeutic regimen must be interrupted for any reason (excluding disease progression), ABTL0812 will be administered as maintenance therapy until disease progression, onset of unacceptable drug toxicities, or patient/physician's request to discontinue.

A Study of ABTL0812 in Pancreatic Cancer

A Randomized Phase I/II Open Label Study to Assess the Efficacy and Safety of ABTL0812 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Advanced Metastatic Pancreatic Cancer at First Line Therapy

Related Adverse Events as Assessed by CTCAE v4.03

The Cleveland Clinic

ABTL0812. Five cohorts and one extension phase.

Laura Vidal, MD, PhD

Ability Pharmaceuticals promotes a clinical trial to determine the adequate dose of a new drug, ABTL0812, that will be administered orally daily to patients with advanced solid tumors.

This is a phase I/Ib, unicenter, open-label and single-agent study. This study consists of two different parts, a dose escalation phase and an extension phase in patients with advanced solid tumors.

ABTL0812 will be administered orally, daily, for 28 days (considered cycle 1). First endpoint is to determine the Maximum Tolerated Dose (MTD). MTD is defined as the highest dose at which no more than one in six patients experiences a ABTL0812 related Dose-Limiting Toxicity (DLT). DLT will be evaluated during the first treatment cycle.

Dose escalation phase will be performed with an accelerated design of 3 + 3

Once the 28 days cycle has finished, patients may continue receiving ABTL0812 on a daily continuous schedule if the patient is deemed to have clinical benefit from treatment, according to the treating physician. Treatment will continue until disease progression, onset of unacceptable drug toxicities, or patient/physician's request to discontinue.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic Study	NCT04431258	Pancreatic Canc...	ABTL0812 Folfirinox Placebo	18 Years -	Ability Pharmaceuticals SL
ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic Study	NCT04431258	Pancreatic Canc...	ABTL0812 Folfirinox Placebo	18 Years -	Ability Pharmaceuticals SL
A Study of ABTL0812 in Pancreatic Cancer	NCT03417921	Pancreatic Canc...	ABTL0812 Gemcitabine and...	18 Years -	Ability Pharmaceuticals SL
Phase I/Ib Clinical Trial of ABTL0812 in Advanced Cancer Patients	NCT02201823	Cancer	ABTL0812	18 Years -	Ability Pharmaceuticals SL
Phase I/Ib Clinical Trial of ABTL0812 in Advanced Cancer Patients	NCT02201823	Cancer	ABTL0812	18 Years -	Ability Pharmaceuticals SL

Spots Global Cancer Trial Database for abtl0812

Every month we try and update this database with for abtl0812 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for abtl0812

Every month we try and update this database with for abtl0812 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for abtl0812 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.