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MelanomaPhase 1/2NCT00615160

PTK/ZK in Disseminated Malignant Melanoma

A Phase 1/2 study testing PTK787/ZK 222584 and Dacarbazine in people with Melanoma, run by Michael Weichenthal at 4 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
PTK787/ZK 222584 and Dacarbazine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
4 sitesGermany
Study dates
Dec 2006to Sep 2008
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
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  • 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.

Who cannot join

  • 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,
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  • 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,
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to PTK-ZK, or patients who have known hypersensitivity to the study medication
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PTK/ZK (i.e., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, bowel obstruction, or inability to swallow the tablets).
  • Myocardial infarction ≤ 6 months prior to randomization
  • Acute or chronic liver disease (i.e., hepatitis, cirrhosis)
  • Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
  • Chronic renal disease, i.e. Creatinine >1.5 x upper limit of normal (ULN) OR Proteinuria based on dip stick reading positive > +1 OR if the dip stick result is +1, total urinary protein > 500 mg and measured creatinine clearance < 50 ml/min from a 24-hour urine collection Haemoglobin < 9 g/dL (patients may be transfused to achieve Hb > 9 g/dL)
  • Other uncontrolled concomitant condition, including but not limited to:
  • ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious uncontrolled cardiac arrhythmia, uncontrolled diabetes, seizure disorder
  • Psychiatric illness/social situations that would limit compliance with study requirements, or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
  • Human immunodeficiency virus (HIV) infection,
  • Prior enrollment into this study.

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Dpt. of Dermatology, University of Cologne

    Cologne, D-50937

  • Dpt. of Dermatology, University of Essen

    Essen, D-45122

  • Dpt. of Dermatology, University of Frankfurt

    Frankfurt am Main, D-60590

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

    Kiel, D-24105

Other trials in Germany

About this study

Official title: Phase II Randomized, Parallel-Group Trial on PTK-ZK With or Without DTIC in Patients With Non-resectable Metastatic Malignant Melanoma

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

Read the 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).

Conditions
Melanoma
Being tested
PTK787/ZK 222584, Dacarbazine
Keywords
Metastatic melanoma, anti angiogenetic treatment
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PTK787/ZK 222584Drug

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

  • DacarbazineDrug

    Also called DTIC

    Dacarbazine 850 mg/m² on day 1 q4w

Study groups in NCT00615160
Study groupRoleWhat they receive
AExperimentalPTK787/ZK 222584 (PTK-ZK) taken orally with a daily flat dose of 1250 mg on days 1 to 28 (= 1 cycle)
Receives: Drug: PTK787/ZK 222584
BExperimentalcombined treatment with DTIC 850 mg/m² on day 1 + PTK-ZK 1250 mg flat dose on days 1 to 28
Receives: Drug: PTK787/ZK 222584; Drug: Dacarbazine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response defined by RECIST criteria

    Measured: 8 week response rate

Secondary outcomes (4)

  1. Toxicity and safety

    Measured: continuously

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

    Measured: Best response during time of treatment

  3. Time to progression

    Measured: Time of progression

  4. Quality of life (EORTC QLQ C30)

    Measured: During active treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2008 (estimated)
  2. Study startDec 2006
  3. Primary completionSep 2008
  4. Study completionSep 2008

Why it stopped: Substance was withdrawn from further development.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00615160
Sponsor's protocol ID
UKSH A-105
Other IDs
EudraCT No. 2005-002192-32
Status last verified
Sep 2021
First submitted
31 Jan 2008
Last updated
6 Oct 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PTK787/ZK 222584 and Dacarbazine in people with Melanoma, run by Michael Weichenthal at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Substance was withdrawn from further development.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response defined by RECIST criteria (time frame: 8 week response rate). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00615160.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.

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