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A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of PARP in Combination With Dacarbazine

Primary Purpose

Melanoma Neoplasms

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
KU-0059436 (AZD2281)(PARP inhibitor)
dacarbazine
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma Neoplasms focused on measuring Poly(ADP ribose) polymerases, dacarbazine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have:

    1. Unresectable stage 3 or stage 4 cutaneous melanoma or unknown primary melanoma with metastases.
    2. Histological or cytological confirmation of melanoma. Histological confirmation of melanoma from the primary site will suffice, unless the primary site is unknown.

Exclusion Criteria:

  • Previous treatment with cytotoxic chemotherapy for advanced melanoma, apart from treatment for melanoma with isolated limb perfusion.
  • Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or use of other investigational agents within 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used).
  • Major surgery within 4 weeks of starting the study.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

DTIC + KU-0059436

Outcomes

Primary Outcome Measures

To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 in combination with dacarbazine.

Secondary Outcome Measures

Objective tumour response

Full Information

First Posted
August 13, 2007
Last Updated
May 14, 2009
Sponsor
AstraZeneca
Collaborators
KuDOS Pharmaceuticals Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00516802
Brief Title
A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of PARP in Combination With Dacarbazine
Official Title
A Phase I, Open Label, Study of the Safety and Tolerability of KU-0059436 and Dacarbazine in the Treatment of Patients With Advanced Solid Tumours
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca
Collaborators
KuDOS Pharmaceuticals Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase I, open-label, dose-escalating, study of the safety and tolerability of KU-0059436 in combination with DTIC in the treatment of patients with advanced melanoma who have not previously received systemic cytotoxic chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma Neoplasms
Keywords
Poly(ADP ribose) polymerases, dacarbazine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
DTIC + KU-0059436
Intervention Type
Drug
Intervention Name(s)
KU-0059436 (AZD2281)(PARP inhibitor)
Other Intervention Name(s)
Olaparib
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
dacarbazine
Other Intervention Name(s)
DTIC
Intervention Description
intravenous injection over at least 20 minutes
Primary Outcome Measure Information:
Title
To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 in combination with dacarbazine.
Time Frame
assessed every 3 weeks
Secondary Outcome Measure Information:
Title
Objective tumour response
Time Frame
assessed every 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have: Unresectable stage 3 or stage 4 cutaneous melanoma or unknown primary melanoma with metastases. Histological or cytological confirmation of melanoma. Histological confirmation of melanoma from the primary site will suffice, unless the primary site is unknown. Exclusion Criteria: Previous treatment with cytotoxic chemotherapy for advanced melanoma, apart from treatment for melanoma with isolated limb perfusion. Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or use of other investigational agents within 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used). Major surgery within 4 weeks of starting the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof James Carmichael, BSc MBChB MD FRCP
Organizational Affiliation
KuDOS Pharmaceuticals Ltd
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Prof Martin Gore, PhD MRCP FRCR
Organizational Affiliation
Royal Marsden Hospital Trust, London, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Manchester
Country
United Kingdom
Facility Name
Research Site
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of PARP in Combination With Dacarbazine

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