Japanese Phase I Study of AZD2014 in Advanced Solid Malignancies

NCT02398747 | Completed Phase 1

• 1 other identifier: D2270C00008
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of this study is to investigate the safety and tolerability of continuous and/or intermittent dosing of AZD2014 when given orally to patients with advanced solid malignancies.

Conditions

Advanced Solid Malignancies

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability measured by adverse events

  This will be assessed in terms of Adverse Events (AEs), laboratory data, vital signs, ECG and physical exams

  6 months in average

Secondary Outcomes (6)

• Cmax of AZd2014

  21 days

• AUC(Area under the plasma concentration-time curve) of AZD2014

  21 days

• Tmax of AZD2014

  21 days

• To obtain a preliminary assessment of the anti-tumour activity of AZD2014 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.

  6 months in average

• To obtain a preliminary assessment of the anti-tumour activity of AZD2014 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.

  6 months in average

Study Arms (1)

AZD2014 50mg, 125mg, 25mg and 50mg intermittent BD

EXPERIMENTAL

50mg BD continuous dosing, 125mg BD intermittent dosing, 25 mg and 50mg intermittent dosing with weekly Paclitaxel

Drug: AZD2014

Interventions

AZD2014 DRUG

50mg continuous dosing, 125mg intermittent dosing, 25 mg and 50mg intermittent dosing with weekly Paclitaxel

AZD2014 50mg, 125mg, 25mg and 50mg intermittent BD

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Chūōku, 104-0045, Japan

Location

Research Site

Kashiwa, 277-8577, Japan

Location

Related Links

• AstraZenecaClinicaltrials.com

MeSH Terms

Interventions

vistusertib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 25, 2015
• Study Start: March 17, 2015
• Primary Completion: April 12, 2024
• Study Completion: April 12, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

JP (2)