Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of AZD2014

NCT01026402 | Completed Phase 1 Results

• 2 other identifiers: D2270C000012009-015244-42
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 2

Brief Summary

The main purpose of the study is to establish a safe dose of the drug by providing information on any potential side effects this drug may cause and collecting data about how a patient's cancer responds to the drug. The study will also assess the blood levels and action of AZD2014 in the body over a period of time and will indicate whether the drug has an effect on the types of cancer the patients have.

Conditions

Advanced Solid Malignancies

Keywords

Phase I; cancer; advanced solid malignancies; dose escalation; AZD2014; mTor kinase inhibitor; safety; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dose Limiting Toxicities (DLTs)

  Maximum Tolerated Dose (MTD) was determined by testing various doses and schedules of AZD2014 in cohorts of 3-6 evaluable patients. MTD reflects the highest dose of drug at each schedule that did not cause a DLT in \>1 patient

  Up to 21 days from first multiple dose

Secondary Outcomes (15)

• Best Objective Response

  Assessed every 8 weeks until progression or withdrawal, whichever came first, estimated to be up to 4 months

• Maximum Concentration (Cmax) Single Dose

  Following Single Dose up to 12, 24 or 48 hours post dose

• Area Under the Curve (AUC) Single Dose

  Following Single Dose up to 12, 24 or 48 hours post dose

• Maximum Concentration (Cmax) at Steady State

  Multiple dosing to steady state (up to 12 or 48 hours post dose)

• Area Under the Curve (AUC) at Steady State

  Multiple dosing to steady state (up to 12 or 48 hours post dose)

Study Arms (1)

AZD2014

EXPERIMENTAL

AZD2014 dose escalation phase in Part A and expansion phase in Part B.

Drug: AZD2014

Interventions

AZD2014 DRUG

Dose escalation phase: a single dose taken orally (solution or tablet) of AZD2014 on single dose day 1 (visit 2), followed by once or twice daily continuous dosing after a washout period (48 hours - 7 days) at visit 4, until discontinuation or withdrawal or Single or multiple doses taken orally (solution or tablet) of AZD2014 taken intermittently until discontinuation or withdrawal. Expansion phase: twice daily dosing from day 1 until discontinuation or withdrawal or a single dose taken orally of AZD2014 on single dose day 1 (visit 2), followed by a single dose on second single dose day 1 (visit 3) after a washout period (48 hours - 7 days) followed by once or twice daily continuous dosing after a washout period (48 hours - 7 days) at visit 4, until discontinuation or withdrawal or single or multiple doses taken orally (solution or tablet) of AZD2014 taken intermittently until discontinuation or withdrawal.

AZD2014

Eligibility Criteria

• Age: 18 Years - 150 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
• At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by computerised tomography (CT) magnetic resonance imaging (MRI) or plain X-ray and is suitable for repeated assessment
• World Health Organisation performance status 0-2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks

You may not qualify if:

• Patients with severe laboratory abnormalities for haematology, liver or renal function. Also treatment with any haemopoietic growth factors are not allowed within two weeks prior to first dose of study drug
• Patients with abnormal fasting glucose, type I or uncontrolled type II diabetes
• Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Manchester, United Kingdom

Location

Research Site

Sutton, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

vistusertib

Results Point of Contact

• Title: Bryony Harrop
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

01625 582828

Study Officials

• Dr. Udai Banerji

  The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey SM2 5PT

  PRINCIPAL INVESTIGATOR

• Elisabeth Oelmann

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 4, 2009
• Study Start: December 1, 2009
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 11, 2016
• Results First Posted: February 11, 2016

Record last verified: 2016-01

Locations

GB (2)