Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Dose of AZD1208 will be escalated from 120mg to a maximum tolerated dose

AZD1208

Frank Neumann, MSD

The purpose of this study is to investigate the safety and tolerability of AZD 1208 up to a maximum tolerated dose (MTD) and define the dose(s) for further clinical evaluation when given daily to patients with advanced solid malignancies including malignant lymphoma

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD1208 in Patients with Advanced Solid Malignancies including Malignant Lymphoma

Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD1208 in Patients With Advanced Solid Malignancies Including Malignant Lymphoma

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions (TL)s since baseline and any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of TLs; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD), at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm; Not Evaluable (NE), this is only relevant if any of the TLs were not assessed or not evaluable or had a lesion intervention at this visit, also note that if the sum of diameters meets the progressive disease criteria, progressive disease overrides not evaluable as a TL response. Best objective response is the best response a patient experiences over the randomised treatment period.

AstraZeneca

AZD1208 120mg

AZD1208 240mg

AZD1208 360mg

AZD1208 540mg

AZD1208 700mg

AZD1208 800mg

Total

Age, Continuous

Sex: Female, Male

Karen Keating

SD >=6 weeks (unconfirmed CR or PR)

SD >=6 weeks (SD)

PD (RECIST progression)

PD (Death)

Not evaluable (SD < 6 weeks)

Not evaluable(Incomplete postbaseline assessments)

All patients who were evaluable for Response analysis set for RECIST criteria

Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)

Overall Study

Spots Global Cancer Trial Database for Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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Contact Details

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