NCT01588548

Brief Summary

The purpose of this study is to investigate the safety and tolerability of AZD 1208 up to a maximum tolerated dose (MTD) and define the dose(s) for further clinical evaluation when given daily to patients with advanced solid malignancies including malignant lymphoma

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2012

Typical duration for phase_1

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 19, 2015

Completed
Last Updated

November 4, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

April 27, 2012

Results QC Date

July 24, 2015

Last Update Submit

October 6, 2015

Conditions

Advanced Solid MalignanciesMalignant Lymphoma

Keywords

Advanced solid malignanciesMalignant lymphoma

Outcome Measures

Primary Outcomes (1)

  • Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions (TL)s since baseline and any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of TLs; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD), at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm; Not Evaluable (NE), this is only relevant if any of the TLs were not assessed or not evaluable or had a lesion intervention at this visit, also note that if the sum of diameters meets the progressive disease criteria, progressive disease overrides not evaluable as a TL response. Best objective response is the best response a patient experiences over the randomised treatment period.

    Measurements occur at screening (<=28 days before start of study treatment), every 6 weeks (+/-1 week) up to 12 weeks and then every 12 weeks (+/-1 week) until discontinuation of study treatment or withdrawal of consent, starting from Day 1 of Cycle 1

Study Arms (1)

AZD1208

ACTIVE COMPARATOR
Drug: AZD1208

Interventions

AZD1208DRUG

Dose of AZD1208 will be escalated from 120mg to a maximum tolerated dose

AZD1208

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have signed this Written Informed Consent Form after a full explanation about the participation in this study
  • Patients aged 18 years or older Patients diagnosed with a solid malignant tumour or malignant lymphoma that is refractory to standard therapies or for which no standard therapies exist
  • Patients with good physical conditions (you can walk and can look after yourself) within the last 2 weeks.
  • Patients who have at least one lesion that can be accurately assessed

You may not qualify if:

  • Patients who have recently received or are receiving prohibited medications or treatments
  • Patients who have any unresolved side effects of previous treatments
  • Patients who have spinal cord compression or brain metastases
  • Patients who have severe systemic diseases (e.g., uncontrolled hypertension, hepatitis B, hepatitis C and human immunodeficiency virus \[HIV\] infection)
  • Patients with significant abnormal ECG findings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Chūōku, Japan

Location

Research Site

Manchester, United Kingdom

Location

Research Site

Surrey, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Lymphoma

Interventions

AZD1208

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Results Point of Contact

Title
Karen Keating
Organization
AstraZeneca
karen.keating@astrazeneca.com
+1 781 839 4182

Study Officials

  • Frank Neumann, MSD

    AZ

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

April 27, 2012

First Posted

May 1, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

November 4, 2015

Results First Posted

August 19, 2015

Record last verified: 2015-10

Locations

GB(2)JP(1)