A Phase 1/2A Study of LAM561 in Adult Patients With Advanced Solid Tumours

Summary

This is a phase 1/2A, open label, non-randomized study in patients with advanced solid tumours including malignant glioma

Conditions

• Glioma
• Other Solid Tumours

Interventions

DRUG

LAM561

Patients will receive treatment cycles of 21 days, until any criterion for discontinuation (clinical or radiological progression of disease, clinically unacceptable toxicity, or another "general" discontinuation criterion) is met. Patients are expected to receive between one and 6 cycles of treatment. The treatment period may be extended if clinical benefit is shown. In the event of significant GI toxicity, the treatment schedule may be modified from continuous dosing to an intermittent regime In the case of toxicity, the dose of LAM561 may be reduced or delayed by up to 14 days at the discretion of the Investigator. A maximum of two dose reductions will be permitted per patient. Treatment "holidays" of no more than 14 days are also permitted for reasons other than toxicity. Intra-patient dose escalation may be permitted in certain specific circumstances.

Sponsors & Collaborators

• Specialized Medical Services (SMS)-Oncology BV

  collaborator UNKNOWN

• Royal Marsden NHS Foundation Trust

  collaborator OTHER

• Northern Institute for Cancer Research, Newcastle

  collaborator UNKNOWN

• Vall d'Hebron Institute of Oncology

  collaborator OTHER

• Instituto Oncológico IMQ, Clínica IMQ Zorrotzaurre. Bilbao

  collaborator UNKNOWN

• Onkologikoa, San Sebastián.

  collaborator UNKNOWN

• Laminar Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Professor Johann de Bono, MB ChB FRCP MSc PhD · The Institute of Cancer Research, 15 Cotswold Road, Belmont, Sutton, Surrey, United Kingdom SM2 5NG

• Prof. Ruth Plummer, BMBCh, MRCP, Cert Me · Northern Institute for Cancer Research, Newcastle

• Dr Jordi Rodon · Vall d'Hebron Institute of Oncology

• Dr Juanita Lopez · The Institute of Cancer Research, 15 Cotswold Road, Belmont, Sutton, Surrey, United Kingdom SM2 5NG

• Dr Ricardo Fernandez Rodriguez · Instituto Oncológico IMQ, Clínica IMQ Zorrotzaurre. Bilbao

• Dr Ander Urruticoechea Ribate · Onkologikoa, San Sebastián.

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2016-09-30

Completion

2016-09-30

Countries

• Spain
• United Kingdom

Study Locations