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AZD1208

Phase 1

Advanced Solid Malignancies | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Nov 4, 2015

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

Clinical trial landscape

AZD1208 · 1 trial · 2 indications

Phase 1 1
NCT01588548Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant LymphomaAdvanced Solid Malignancies
COMPLETED43 Analytics
PHASE1COMPLETED
Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma
Advanced Solid MalignanciesUnlock trial analytics

Study Endpoints

Primary Endpoints

Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)
Measurements occur at screening (<=28 days before start of study treatment), every 6 weeks (+/-1 week) up to 12 weeks and then every 12 weeks (+/-1 week) until discontinuation of study treatment or withdrawal of consent, starting from Day 1 of Cycle 1

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.

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD1208ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
AZD1208DRUGDose of AZD1208 will be escalated from 120mg to a maximum tolerated dose
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Eligibility Criteria

Age Range18 Years to 130 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patients who have signed this Written Informed Consent Form after a full explanation about the participation in this study * Patients aged 18 years or older Patients diagnosed with a solid malignant tumour or malignant lymphoma that is refractory to standard therapies or for w...

Countries:JapanUnited Kingdom
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Frequently asked questions about AZD1208

What is AZD1208 used for?

AZD1208 is an investigational small molecule being studied for the treatment of advanced solid malignancies and malignant lymphoma. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who is developing AZD1208?

AZD1208 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 1 clinical development for oncology indications.

What phase is AZD1208 in?

AZD1208 is in Phase 1 clinical development. It is an investigational drug being studied for advanced solid malignancies and malignant lymphoma, and it has not been approved for commercial use.

What clinical trials is AZD1208 in?

AZD1208 has been studied in a Phase 1 clinical trial with the identifier NCT01588548. This trial assessed the safety and tolerability of AZD1208 in patients with advanced solid tumors and malignant lymphoma, and it has been completed.

Is AZD1208 the same as any other drug?

AZD1208 is a distinct investigational compound developed by AstraZeneca. It is not known to be marketed under any other name, and it remains in clinical development for oncology indications.