Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-08 @ 3:31 AM
Study NCT ID:
NCT00615160
Status:
TERMINATED
Last Update Posted:
2021-10-06
First Post:
2008-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PTK/ZK in Disseminated Malignant Melanoma
Sponsor:
Michael Weichenthal
Organization:
Study Overview
Official Title:
Phase II Randomized, Parallel-Group Trial on PTK-ZK With or Without DTIC in Patients With Non-resectable Metastatic Malignant Melanoma
Status:
TERMINATED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Substance was withdrawn from further development.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the efficacy of PTK-ZK on metastatic melanoma either as a single agent treatment or in combination with standard chemotherapy according to RECIST criteria. Further to evaluate the safety and tolerability of PTK-ZK in patients with metastatic melanoma either as a single agent treatment or in combination with standard chemotherapy
Detailed Description:
This is a multicenter, randomized, open-label, parallel-group phase II study to evaluate the efficacy and safety of PTK-ZK in the treatment of patients with metastatic malignant melanoma who do not qualify for surgical resection:
* progressive locoregionary disease not to be controlled by surgical measures
* distant metastasis other than brain metastasis not eligible for surgical resection or radiotherapy All patients will be treated with PTK-ZK 1250mg administered orally once a day for treatment cycles of 28 days. In case of unacceptable toxicity the dose can be reduced to 1000 mg and further on to 750 mg daily.
Patients in Arm B additionally receive intravenous DTIC 850mg/m² on day 1 of each cycle.
After informed consent is given by the patient a biopsy from a metastasis should be taken before the first intake of study medication and at the end of cycle 2 to specify markers of angiogenesis and MVD (Micro vessel density).
* progressive locoregionary disease not to be controlled by surgical measures
* distant metastasis other than brain metastasis not eligible for surgical resection or radiotherapy All patients will be treated with PTK-ZK 1250mg administered orally once a day for treatment cycles of 28 days. In case of unacceptable toxicity the dose can be reduced to 1000 mg and further on to 750 mg daily.
Patients in Arm B additionally receive intravenous DTIC 850mg/m² on day 1 of each cycle.
After informed consent is given by the patient a biopsy from a metastasis should be taken before the first intake of study medication and at the end of cycle 2 to specify markers of angiogenesis and MVD (Micro vessel density).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| EudraCT No. 2005-002192-32 | None | None | View |