Completed

A Phase 1/2A Dose Escalation Study of LAM561 in Adult Patients With Advanced Solid Tumours Including Malignant Glioma

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What is being tested

LAM561

+ LAM561

+ LAM561

Drug
Who is being recruted

Neoplasms+5

+ Neoplasms by Histologic Type

+ Neoplasms, Germ Cell and Embryonal

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: May 2013
See protocol details

Summary

Principal SponsorLaminar Pharmaceuticals
Last updated: February 21, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2013

Actual date on which the first participant was enrolled.

This is an open label, non-randomized study in patients with advanced solid tumours including malignant glioma. The study will be performed in two phases - a dose escalation phase following a standard "3+3" design to establish dose-limiting toxicity (DLT) and a safe dose of LAM561 followed by two expanded safety cohorts (approximately 10 of whom have malignant glioma and approximately 10 of whom have other advanced solid tumours that are suitable for biopsy) treated at the maximum tolerated dose (MTD). If the MTD is well tolerated in the expanded safety cohorts, that dose becomes the recommended phase 2 dose (RP2D). During each dose cohort, at least one week must elapse between the first and subsequent patients receiving treatment with LAM561. Patients may receive palliative localized radiotherapy, if needed (however, this lesion cannot be a target lesion for evaluation of the treatment response). Safety, pharmacokinetics (PK), pharmacodynamics and efficacy will be evaluated during the study at pre-defined timepoints

NCT01792310
Principal SponsorLaminar Pharmaceuticals
Last updated: February 21, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

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

54 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeoplasms, NeuroepithelialGlioma

Criteria

7 inclusion criteria required to participate
Eastern cooperative oncology group (ECOG) performance status of 0-2
Histologically- or cytologically-confirmed advanced solid malignancy that is refractory to standard-of-care treatment, or for which there is no standard therapy. If this is glioma:Grade III / Grade IV malignant glioma recurring or progressing after first or second line standard-of-care treatment and true progressive disease, confirmed according to the RANO criteria 4
Life-expectancy of at least 12 weeks
Males or females providing written, informed consent
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9 exclusion criteria prevent from participating
Anti cancer therapy within 4 weeks (6 weeks for mitomycin and nitrosureas and 2 weeks for palliative radiotherapy)
Concurrent severe and/or uncontrolled other medical disease that could compromise participation in the study
History of uncontrolled hyperlipidemia and/or the need for concurrent lipid lowering therapy
Known impairment of GI function that could alter the absorption of study drug
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

9 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Intervention: LAM561. 7 dose cohorts of up to 6 patients have been performed in the dose escalation phase. The starting dose cohort received 250 mg twice daily.

Group II

Experimental
Intervention: LAM561. 500 mg twice daily

Group III

Experimental
Intervention: LAM561. 1g twice daily

Group IV

Experimental
Intervention: LAM561. 2g twice daily

Group 5

Experimental
Intervention: LAM561. 4g twice daily

Group 6

Experimental
Intervention: LAM561. 4g three times daily

Group 7

Experimental
Intervention: LAM561. 8g twice daily

Group 8

Experimental
Intervention: LAM561 at the MTD: 4g three times daily. Up to 10 patients with malignant glioma.

Group 9

Experimental
Intervention: LAM561 at the MTD: 4g three times daily. Up to 10 patients with other advanced solid tumours that are suitable for biopsy.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Vall D'Hebron Institute of Oncology

Barcelona, SpainOpen Vall D'Hebron Institute of Oncology in Google Maps

Instituto Oncológico IMQ, Clínica IMQ Zorrotzaurre

Bilbao, Spain

Onkologikoa

San Sebastián, Spain

Sir Bobby Robson Cancer Trials Research Centre, The Northern Centre for Cancer Care, Freeman Hospital

Newcastle, United Kingdom
Completed5 Study Centers