Japanese Phase I Study of AZD2014 in Advanced Solid Malignancies
NCT ID: NCT02398747
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2015-03-17
2024-04-12
Brief Summary
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Detailed Description
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Safety, preliminary efficacy and PK (single and multiple dose) are evaluated in this study.
Patients will receive a single dose of AZD2014 on Day 1 (to allow assessment of single dose PK), then after a minimum of 48 hours washout period continuous or intermittent twice daily dosing of AZD2014 will be initiated. The washout period of 48 hours may be extended depending on emerging data from previous cohorts.Doses and schedules to be evaluated will be agreed by AstraZeneca and the Safety Review Committee (SRC).
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AZD2014 50mg, 125mg, 25mg and 50mg intermittent BD
50mg BD continuous dosing, 125mg BD intermittent dosing, 25 mg and 50mg intermittent dosing with weekly Paclitaxel
AZD2014
50mg continuous dosing, 125mg intermittent dosing, 25 mg and 50mg intermittent dosing with weekly Paclitaxel
Interventions
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AZD2014
50mg continuous dosing, 125mg intermittent dosing, 25 mg and 50mg intermittent dosing with weekly Paclitaxel
Eligibility Criteria
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Inclusion Criteria
* For Cohort 3-1 and 3-2, followed as, Histological or cytological confirmation of a solid, malignant tumour that is refractory to standard therapies or for which no standard therapies exist or where treatment with paclitaxel is an appropriate treatment option. SqNSCLC patients are excluded from the Cohort 3-2.
* World Health Organisation (WHO) performance status (PS) 0-1 with no deterioration over the previous 2 weeks prior to informed consent and minimum life expectancy of 12 weeks
* At least one lesion that can be accurately assessed at baseline by computed tomography (CT) magnetic resonance imaging (MRI) or plain X-ray and is suitable for repeated assessment
Exclusion Criteria
* Major surgery within 4 weeks prior to the study treatment (excluding placement of vascular access), or minor surgery within 2 weeks prior to the study treatment
* Potent or moderate inhibitors or inducers of cytochrome (CYP) 3A4/5 if taken within the stated washout periods:
* Potent or moderate inhibitors or inducers of CYP2C8 if taken within the stated washout periods:
* Exposure to sensitive or narrow therapeutic range substrates of the drug metabolising enzymes CYP2C8, CYP2C9, CYP2C19, CYP2D6 or the drug transporters P-gp (MDR1), Breast cancer resistance protein (BCRP), Organic anion transporting polypeptide (OATP)1B1, OATP1B3, Organic cation transporter (OCT)1 and OCT2 within the appropriate wash-out period (at least 5 x reported terminal elimination half-life (t1/2) of each drug) before the study treatment.
* Any haemopoietic growth factors (eg, granulocyte-colony stimulating factor \[G-CSF\]) within 2 weeks prior to receiving study drug
* Previous initiation of treatment with AZD2014 in the present study or prior treatment with AZD8055
* With the exception of alopecia, any unresolved toxicities from prior chemotherapy greater than Common toxicity criteria for adverse events (CTCAE) grade 1 at the time of starting study treatment
* Spinal cord or brain metastases unless asymptomatic and stable off steroids for at least 4 weeks prior to start of study treatment
* Subjects with interstitial lung disease as a complication or a history
20 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Chūōku, , Japan
Research Site
Kashiwa, , Japan
Countries
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Related Links
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AstraZenecaClinicaltrials.com
Other Identifiers
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D2270C00008
Identifier Type: -
Identifier Source: org_study_id