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Refractory MalignancyPhase 1NCT00611689

Imatinib and PTK787/ZK222584 in Refractory and/or Advanced Solid Tumors

A Phase 1 study testing Imatinib and PTK/ZK222584 in people with Refractory Malignancy and Solid Tumors, run by SCRI Development Innovations, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this phase I study, the investigators will determine the maximum tolerated doses of imatinib and PTK/ZK administered in two different dose schedules. Due to the different mechanisms of action and the minimally-overlapping toxicity profiles of these two novel oral agents, it is hoped that a combination regimen… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Refractory Malignancy, Solid Tumors
What is being tested?
Imatinib and PTK/ZK222584
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
Jul 2004to Apr 2011
Phase
Phase 1
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

  • Patients must have biopsy-proven, advanced, incurable solid tumors refractory to standard treatment or for which there is no known standard treatment.
  • ECOG performance status 0 or 1.
  • Life expectancy of at least three months.
  • At least three weeks from any previous chemotherapy or 4 weeks from all investigational treatment
  • Completed any previous radiotherapy at least two weeks prior to study entry.
  • Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN, creatinine < 1.5 x ULN, ANC > 1500/µL, platelets > 100,000/µL.
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  • Serum bilirubin <= 1.5 x the institutional upper-limit of normal and alkaline phosphatase, AST (SGOT), and ALT (SGPT) <= 2.5 x the institutional upper-limit of normal (within 7 days prior to initial treatment).
  • Hemoglobin >= 9 gm/dL (may be transfused or receive erythropoietin to maintain or exceed this level).
  • Patients with a history of brain metastases are eligible, but only if they have had previous treatment for the metastases and these are inactive and asymptomatic at the time of enrollment in this study.
  • Patients must be able to understand the nature of this study and give written informed consent.
  • Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug. Oral, injectable, and injection contraceptives should not be considered effective as they may be affected by cytochrome P450 interactions.
  • Must have evaluable-disease
  • Must be > 18 years of age.
  • Patients may have received prior systemic chemotherapy, i.e. there is no limit on the number of prior regimens the patient may have received.

Who cannot join

  • Female patients who are pregnant or are lactating.
  • History of acute myocardial infarction within 6 months. In addition, patients are ineligible if they have clinically significant cardiovascular disease (e.g. uncontrolled hypertension, unstable angina), New York Heart Association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or > grade II peripheral vascular disease.
  • Patients with a prior malignancy (except for adequately treated basal-cell or squamous-cell skin cancers, in situ carcinomas, or low grade [Gleason score 3+3 or less] localized prostate cancer) in the past 5 years will be excluded.
  • Patients with active concurrent infections or patients with serious underlying medical conditions will be excluded from the study.
  • Women who are pregnant or lactating are ineligible. All men and women of reproductive potential must agree to use effective contraception while receiving treatment in this study. (See 3.1.11)
  • Patients who are concurrently using phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, systemic retinoids, or St. John's Wort are ineligible.
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  • Patients who have had a prior grade 4 thromboembolic event are ineligible. Patients who have had a grade 3 thromboembolic event are ineligible unless they have an in-range INR (usually between 2 and 3) on a stable dose of low molecular weight heparin or unfractionated heparin. In addition, patients who have clinical or radiologic evidence of clots in the renal veins, inferior vena cava, hepatic veins, or portal vein are ineligible. Since warfarin is metabolized through the CYP450 system, no therapeutic anticoagulation with warfarin (e.g. Coumadin or Coumadine) will be permitted in patients participating in this study. As an alternative, therapeutic anticoagulation may be accomplished using low-molecular weight heparin (e.g. Lovenox) or heparin. Mini-Dose Coumadin (e.g. 1 mg qd) is permitted for prophylaxis of central venous catheter thrombosis, at the discretion of the treating physician. In general, the use of Coumadin is discouraged on this protocol.
  • Major surgical procedure, open biopsy; or significant traumatic injury within 28 days or anticipation of need for major surgical procedure during the course of the study.
  • Patients with PEG or G-tubes are ineligible.
  • Proteinuria; if > 1+ on dipstick at baseline patients must have 24-hour urine collection. Patients with > 500mg protein/24 hrs are ineligible. (See Appendix A - Evaluation and Management of Proteinuria).
  • Any nonhealing wound, ulcer, or bone fracture.
  • Any clinical evidence or history of a bleeding diathesis or coagulopathy.
  • Participation in another experimental drug study within 28 days of starting treatment.
  • History of any other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications.
  • Presence of poorly controlled hypertension (as defined by the treating clinician) If a patient's condition is deteriorating, laboratory evaluations should be repeated < 48 hours prior to initiation of therapy.
  • Prior VEGF therapy.
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PTK787/ZK 222584 (i.e. ulcerative disease, uncontrolled nausea, vomiting diarrhea, malabsorption syndrome, bowel obstruction, or inability to swallow the tablets).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37023

Other trials in United States

About this study

Official title: A Phase I Study to Determine the Safety of Imatinib in Combination With PTK787/ZK222584 in Patients With Refractory and/or Advanced Solid Tumors

In this phase I study, the investigators will determine the maximum tolerated doses of imatinib and PTK/ZK administered in two different dose schedules. Due to the different mechanisms of action and the minimally-overlapping toxicity profiles of these two novel oral agents, it is hoped that a combination regimen incorporating both compounds will produce increased activity without enhanced toxicity. After completion of this phase I study, the investigators propose a follow-up phase II study in patients with previously treated metastatic renal cell cancer - where VEGF and PDGF appear to play important roles in the malignant phenotype - to determine the antitumor efficacy of the recommended dose of this combination regimen.

Being tested
Imatinib and PTK/ZK222584
Keywords
Refractory Malignancy, Solid Tumors, PTK787, ZK222584
Medical subject headings
Neoplasms

What participants receive

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

  • Imatinib and PTK/ZK222584Drug

    Imatinib and PTK/ZK will each be administered orally daily. Two dose levels of imatinib (400 mg and 600 mg) will be tested with 4 dose levels of PTK/ZK (250 mg, 500 mg, 750 mg, and 1000 mg). 3 patients will be accrued at each individual dose level. If dose-limiting toxicities are reported in ≤ 1/3 patients, the dose level will be expanded to 6 patients. If dose-limiting toxicities are reported in < 2/6 patients, then dose escalation will continue. If ≥ 2/6 patients experience dose-limiting toxicity, the next lower dose will be considered the maximum tolerated dose and will be expanded to a total of 12 patients. There will be no intrapatient dose escalations. Patients may continue to receive treatment until unacceptable toxicity or disease progression is encountered.

Study groups in NCT00611689
Study groupRoleWhat they receive
AExperimentalImatinib and PTK/ZK222584
Receives: Drug: Imatinib and PTK/ZK222584

What is being measured

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

  1. MTD and the recommended phase II doses of imatinib and PTK/ZK administered daily every 28 days

    Measured: 18 months

Timeline

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

  1. First posted11 Feb 2008 (estimated)
  2. Study startJul 2004
  3. Primary completionJan 2008
  4. Study completionApr 2011

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00611689
Sponsor's protocol ID
SCRI REFMAL 51
Status last verified
Jan 2013
First submitted
28 Jan 2008
Last updated
4 Feb 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Imatinib and PTK/ZK222584 in people with Refractory Malignancy and Solid Tumors, run by SCRI Development Innovations, LLC at 1 site in United States.

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 14 inclusion and 17 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: finished, as of the sponsor's last update on 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

MTD and the recommended phase II doses of imatinib and PTK/ZK administered daily every 28 days (time frame: 18 months). 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 NCT00611689.

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 4 Feb 2013.

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