PTK/ZK in Disseminated Malignant Melanoma

NCT00615160 | Terminated Phase 1 DMC

• 2 other identifiers: UKSH A-105EudraCT No. 2005-002192-32
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

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

Conditions

Melanoma

Keywords

Metastatic melanoma; anti angiogenetic treatment

Outcome Measures

Primary Outcomes (1)

• Overall response defined by RECIST criteria

  8 week response rate

Secondary Outcomes (4)

• Toxicity and safety

  continuously

• Tumor control as defined by the number of patients with objective tumor response or tumor stabilization according to RECIST criteria

  Best response during time of treatment

• Time to progression

  Time of progression

• Quality of life (EORTC QLQ C30)

  During active treatment

Study Arms (2)

A

EXPERIMENTAL

PTK787/ZK 222584 (PTK-ZK) taken orally with a daily flat dose of 1250 mg on days 1 to 28 (= 1 cycle)

Drug: PTK787/ZK 222584

B

EXPERIMENTAL

combined treatment with DTIC 850 mg/m² on day 1 + PTK-ZK 1250 mg flat dose on days 1 to 28

Drug: PTK787/ZK 222584; Drug: Dacarbazine

Interventions

PTK787/ZK 222584 DRUG

PTK-ZK capsules taken orally with a daily flat dose of 1250 mg

A; B

Dacarbazine DRUG

Dacarbazine 850 mg/m² on day 1 q4w

Also known as: DTIC

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed nonresectable metastatic melanoma Stage III or IV (AJCC 2002) including patients with unknown primary melanoma,
• Progressive disease, defined as an increase of tumour volume according to RECIST criteria, within the last 6 months,
• Fulfilling the minimum RECIST requirements for evaluation of tumor response,
• At least two cutaneous or soft tissue lesions that can be biopsised prior to and after treatment, respectively,
• Able to undergo either contrast-enhanced CT scan or contrast-enhanced MRI scan for tumor assessment,
• Life expectancy greater than 3 months,
• ECOG performance status \<2,
• Age \> 18 years,
• Able to swallow and retain intact investigational drug tablets,
• Willingness and ability to adhere to the study requirements as outlined in the protocol,
• Agreement to use a highly effective method of birth control throughout the study period and 3 months thereafter for sexually active males and females of childbearing potential. Barrier contraceptives must be used throughout the trial. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study.
• Able to provide informed consent.

You may not qualify if:

• One or more previous systemic therapies for metastatic melanoma, excluding prior systemic therapy given for high-risk primary tumor, lymph node metastasis, or other regional (AJCC stage III) disease spread as postoperative adjuvant therapy.
• Anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy, and hormone therapy) delivered within 4 weeks prior to the 1st dose of study drug, and 2 weeks prior for palliative "spot" radiotherapy to bone metastases),
• History of uveal melanoma,
• Female patients who are pregnant or breast feeding. Women of childbearing potential must have a negative serum pregnancy test 48 hours prior to administration of study treatment.
• Impaired organ and bone marrow function defined as one or more of the following:
• Absolute neutrophil count (ANC) \<1,500/µl,
• Platelets \<100,000/µl,
• Total bilirubin \>1.5 x ULN,
• ASAT (SGOT)/ALAT (SGPT) \> 3x ULN (5x if liver metastases are present)
• History or presence of central nervous system (CNS) disease (i.e., primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis)
• Another malignancy in the 5 years prior to enrollment other than non melanoma skin cancer, or cervix carcinoma in situ,
• Major Surgery \< 10 days prior to the start of study treatment
• Inadequate recovery from previous surgery, radiation, chemo-, biologic or immunotherapy
• Ongoing effects from previous investigational drug studies or concomitant participation in other investigational drug studies
• Prior use of PTK-ZK or other VGEF receptor antagonists,

Sponsors & Collaborators

• Michael Weichenthal: lead

Study Sites (4)

Dpt. of Dermatology, University of Cologne

Cologne, D-50937, Germany

Location

Dpt. of Dermatology, University of Essen

Essen, D-45122, Germany

Location

Dpt. of Dermatology, University of Frankfurt

Frankfurt am Main, D-60590, Germany

Location

Dpt. of Dermatology; UK-SH Campus Kiel, Germany

Kiel, D-24105, Germany

Location

MeSH Terms

Conditions

Melanoma

Interventions

vatalanib; Dacarbazine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Michael Weichenthal, MD

  UK-SH Department of Dermatology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 14, 2008
• Study Start: December 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: October 6, 2021

Record last verified: 2021-09

Locations

DE (4)