Japanese Phase I Study of AZD2014 in Advanced Solid Malignancies

Study identifier:D2270C00008

ClinicalTrials.gov identifier:NCT02398747

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered to Japanese Patients with Advanced Solid Malignancies

Medical condition

Advanced solid malignancies

Phase

Phase 1

Healthy volunteers

Study drug

AZD2014

Sex

All

Actual Enrollment

Study type

Interventional

Age

20 Years - 80 Years

Date

Study Start Date: 17 Mar 2015

Estimated Primary Completion Date: 28 Feb 2025

Estimated Study Completion Date: 28 Feb 2025

Study design

Allocation: Non-randomized
Endpoint Classification: Safety
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

:
-Histological or cytological confirmation of a solid, malignant tumour that is refractory to standard therapies or for which no standard therapies exist
- 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

- Prior chemotherapy, biological therapy, radiation therapy, antiandrogens, other anticancer therapies including immunotherapy and any investigational agents within 21 days of starting study treatment (not including palliative radiotherapy at focal sites), or corticosteroids within 14 days of starting study treatment.
- 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

No locations available

Arms	Assigned Interventions
Experimental: 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	Drug: AZD2014 50mg continuous dosing, 125mg intermittent dosing, 25 mg and 50mg intermittent dosing with weekly Paclitaxel

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]