A Phase I, open label study of extended dosing with PatrinTM in combination with temozolomide in the treatment of patients with advanced melanoma.

A Phase I, open label study of extended dosing with Patrin in combination with temozolomide in the treatment of patients with advanced melanoma. Part 1- to establish a dose for Part 2. Part 2 to test efficacy and safety of the dose established in Part 1.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000625673

Acronym

PAT/105

Enrollment

132

Registered

2005-10-11

Start date

2005-08-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Patrin combined with temozolomide for 6 cycles.

Study design

Allocation

Non-randomised trial

Intervention model

Other

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Unresectable stage 3 /4 measurable (RECIST criteria), histologically proven cutaneous melanoma or unknown primary with melanoma metastases, without systemic treatment for metastatic disease.

Exclusion criteria

No exclusion criteria

Outcome results