NCT00516802

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2007

Typical duration for phase_1

Geographic Reach
2 countries

4 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

Study Start

First participant enrolled

January 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

May 15, 2009

Status Verified

May 1, 2009

Enrollment Period

2 years

First QC Date

August 13, 2007

Last Update Submit

May 14, 2009

Conditions

Melanoma Neoplasms

Keywords

Poly(ADP ribose) polymerasesdacarbazine

Outcome Measures

Primary Outcomes (1)

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

    assessed every 3 weeks

Secondary Outcomes (1)

  • Objective tumour response

    assessed every 6 weeks

Study Arms (1)

1

EXPERIMENTAL

DTIC + KU-0059436

Drug: KU-0059436 (AZD2281)(PARP inhibitor)Drug: dacarbazine

Interventions

KU-0059436 (AZD2281)(PARP inhibitor)DRUG

oral

Also known as: Olaparib
1
dacarbazineDRUG

intravenous injection over at least 20 minutes

Also known as: DTIC
1

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Pittsburgh, Pennsylvania, United States

Location

Research Site

London, United Kingdom

Location

Research Site

Manchester, United Kingdom

Location

Research Site

Oxford, United Kingdom

Location

MeSH Terms

Interventions

olaparibDacarbazine

Intervention Hierarchy (Ancestors)

TriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Prof James Carmichael, BSc MBChB MD FRCP

    KuDOS Pharmaceuticals Ltd

    STUDY DIRECTOR

  • Prof Martin Gore, PhD MRCP FRCR

    Royal Marsden Hospital Trust, London, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 13, 2007

First Posted

August 15, 2007

Study Start

January 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

May 15, 2009

Record last verified: 2009-05

Locations

GB(3)US(1)