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AZD2014 3 on/4 off & weekly paclitaxel

Phase 1

Advanced Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Sep 26, 2024

Development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

AZD2014 3 on/4 off & weekly paclitaxel · 1 trial · 1 indication

Phase 1 1
NCT02193633A Phase I Trial of the Combination of AZD2014 and Weekly Paclitaxel.Advanced Cancer
COMPLETED90 Analytics
PHASE1COMPLETED
A Phase I Trial of the Combination of AZD2014 and Weekly Paclitaxel.
Advanced Cancer
NCT0219363390
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Study Endpoints

Primary Endpoints

Establish the maximum tolerated dose and recommended Phase II dose of two intermittent dosing schedules of AZD2014: 3 days on, 4 days off and 2 days on, 5 days off in combination with weekly paclitaxel in patients with solid tumours.
First cycle of treamtent (7 weeks)

To determine the dose at which no more than one patient out of up to 6 patients at the same dose level experience a drug-related dose-limiting toxicity.

Secondary Endpoints

PK parameters for AZD2014 and paclitaxel derived from determining their plasma concentrations using validated assays.
First cycle of treatment (7 weeks)
PK parameters for AZD2014 and paclitaxel derived from determining their plasma concentrations using validated assays
First cycle of treatment (7 weeks)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD2014 3 on/4 off & weekly paclitaxelEXPERIMENTAL3 days on, 4 days off AZD2014 BD administered orally Days 1-3 each week in combination with paclitaxel administered via IV infusion on Day 1 each week, in 7-week cycles (6 weeks treatment followed by 1 week rest).
AZD2014 2 on/5 off & weekly paclitaxelEXPERIMENTALAZD2014 BD administered orally Days 1-2 each week in combination with paclitaxel administered via IV infusion on Day 1 each week, in 7-week cycles (6 weeks treatment followed by 1 week rest).

Interventions

NameTypeDescription
AZD2014 3 on/4 off & weekly paclitaxelDRUGAZD2014 3 days on, 4 days off + weekly paclitaxel
AZD2014 2 on/5 off & weekly paclitaxelDRUGAZD2014 2 days on, 5 Days off + weekly paclitaxel
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Histologically or cytologically proven solid tumour.refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient, or where treatment with paclitaxel is an appropriate treatment option. Patients enrolled in the expansion phase...

Countries:United Kingdom
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Competitive Landscape -Cancer 5 trials (matched to "Advanced Cancer")

Top 2 of 3 competitors

CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520/GEH200521
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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