A Study to Assess the Efficacy and Safety of ABTL0812 (Endolung)

February 20, 2023 updated by: Ability Pharmaceuticals SL

A Phase I/II, Open Label Study to Assess the Efficacy and Safety of ABTL0812 in Combination With Paclitaxel and Carboplatin in Patients With Advanced Endometrial Cancer or Squamous NSCLC

A phase I/ II, open label study to assess the efficacy and safety of ABTL0812 in combination with paclitaxel and carboplatin in patients with advanced endometrial cancer or squamous NSCLC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a phase I/II multicenter divided in two phases.

Phase I: Safety and dose escalation

This study is not randomized, and all included patients will receive ABTL0812 in addition to paclitaxel + carboplatin (SOC). In this phase, patients can be selected from both indications, regardless of the number of each indication.

This phase will be divided in 2 periods:

Period 1:

A dose de-escalation phase will be performed with a 3 + 3 design, in which up to four different ABTL0812 dose levels will be tested in combination with SOC. Then, 12 patients will be included in an expansion phase. All patients will receive one week of ABTL0812 alone followed by ABTL0812 + SOC (up to 8 SOC cycles) as combined treatment.

Period 2:

After the finalization of the SOC cycles, ABTL0812 will be taken as single therapy, at 1300 mg tid, up to 12 months from initiation of period 1. This is the Recommended Phase 2 Dose (RP2D) as monotherapy for ABTL0812 determined in the previous phase I clinical trial.

Phase II: Efficacy and safety

This phase of the study will include up to 33 patients per indication (up to 66 patients overall). The final number will depend on the number of patients included in the phase I. The number of patients selected per indication will depend on the number already selected in phase I, as it is necessary to compensate both indications to have a final number of 40 patients per indication approximately.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08290
        • Abilitypharma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients ≥18 years of age
  • Willing and able to provide informed consent
  • For endometrial cancer: Patients with advanced, metastatic or recurrent endometrial cancer, from all histological types except carcinosarcoma and leiomyosarcoma.
  • For squamous NSCLC: Patients with histologically or radiological/cytologically confirmed diagnosis (non-irradiance IIIb stage or stage IV), excluding mixed tumors, neuroendocrine or adenocarcinoma.
  • Have adequate tumor tissue available (either archival not older than 6 months or new tumor biopsy) for biomarker analyses. The most recently collected tumor tissue sample should be provided, if available.
  • Life expectancy ≥ 12 weeks in the opinion of the investigator
  • 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
  • Contraception: All female patients will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months' consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically. Female patients of childbearing potential must agree to use two forms of highly effective contraception methods during the study and for a period of 6 months following the last administration of the study drug. Male patients and their female partners, who are of childbearing potential and are not practicing total abstinence, must agree to use two forms of highly effective contraception during the study and for a period of 6 months following the last administration of the study drug.

  • Adequate bone marrow function defined as:

    • absolute neutrophil count ≥ 1.5x109/L
    • platelet count ≥ 100x109/L
    • hemoglobin ≥ 10.0 g/dL
  • Total bilirubin ≤ 1.5 x upper limit of normal
  • Aspartate transaminase (AST) ≤ 2.5 times upper limit of normal (ULN) (≤5 times the ULN in patients with evidence of liver metastases)
  • Alkaline phosphatase ≤ 2.5 times ULN (≤5 times the ULN in patients with evidence of liver metastases)
  • Glomerular filtration rate ≥ 50 mL/min
  • Serum creatinine ≤1.5 ULN
  • Toxicities incurred as a result of previous anticancer therapy (radiation therapy, chemotherapy, or surgery) must be resolved to ≤ grade 1 (as defined by Common Terminology Criteria for Adverse Events version 4.02).
  • Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol

Exclusion Criteria:

  • Patients previously treated with an inhibitor of the Phosphoinositide 3-kinase/Protein kinase B/mechanistic target of rapamycin (PI3K/Akt/mTOR) pathway.
  • Patients previously treated with adjuvant or co-adjuvant chemotherapy administered 6 months or less in advance of patient inclusion
  • Patients with symptomatic brain metastases. Patients with asymptomatic and treated brain metastases can be included in the study if they are kept on stable doses of steroids for a period of 1 month prior to study entry provided they don't have peripheric neuropathy grade 2 or superior.
  • Patients with gastrointestinal abnormalities including inability to take oral medications, malabsorption syndromes or other clinically significant gastrointestinal abnormalities that may impair the absorption of the investigational medicinal product.
  • Pregnancy or lactation. Serum pregnancy test to be performed within 7 days prior to study treatment start.
  • Patients with myocardial infarction within ≤ 12 months prior to study entry, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina pectoris, or unstable cardiac arrhythmia requiring medication.
  • Evidence of pre-existing uncontrolled hypertension. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
  • Patients with active Hepatitis B or C or human immunodeficiency virus (HIV) infection with non-controlled disease according to the treating physician.
  • Patients with any other medical conditions (such as psychiatric illness, infectious diseases, abnormal physical examination or laboratory findings) that in the opinion of the investigator may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endometrial cancer
ABTL0812 (starting 1,300 mg tid orally) in combination with paclitaxel and carboplatin will be given to patients with advanced endometrial cancer, up to 12 months from initiation.
Drug: ABTL0812 in combination with paclitaxel and carboplatin
ABTL0812 in combination with paclitaxel and carboplatin.
Experimental: Squamous non-small cell lung cancer
ABTL0812 (starting 1,300 mg tid orally) in combination with paclitaxel and carboplatin will be given to patients with squamous NSCLC, up to 12 months from initiation.
Drug: ABTL0812 in combination with paclitaxel and carboplatin
ABTL0812 in combination with paclitaxel and carboplatin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergent Adverse Events
Time Frame: 1 year
Related Adverse Events as Assessed by CTCAE v4.03
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 2 years
Objective response rate (ORR) based on tumor assessment by CT-Scan according to RECIST criteria version 1.1. performed at baseline and at every other treatment visit, starting at 3rd SOC cycle
2 years
Progression Free Survival (PFS)
Time Frame: 2 years
Progression Free Survival (PFS) based on tumor assessment by CT-Scan according to RECIST criteria version 1.1. performed at baseline and at every other treatment visit, starting at 3rd SOC cycle
2 years
Time to Progression (TP)
Time Frame: 2 years
Time to Progression (TP) based on tumor assessment by CT-Scan according to RECIST criteria version 1.1. performed at baseline and at every other treatment visit, starting at 3rd SOC cycle
2 years
Duration of Response (DR)
Time Frame: 2 years
Duration of Response (DR), based on tumor assessment by CT-Scan according to RECIST criteria version 1.1. performed at baseline and at every other treatment visit, starting at 3rd SOC cycle
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ability Pharmaceuticals SL

Collaborators

Centre Leon Berard
Institut Català d'Oncologia
Institut Paoli-Calmettes
Gustave Roussy, Cancer Campus, Grand Paris
Hospitales Universitarios Virgen del Rocío
Hospital Vall d'Hebron
Hospital Clínico Universitario de Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

November 15, 2020

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

December 7, 2017

First Posted (Actual)

December 8, 2017

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-C5-2016
  • 2016-001352-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endometrial Cancer

Clinical Trials on ABTL0812 in combination with paclitaxel and carboplatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe