Metastatic CancerPhase 2NCT00390468
Tandutinib in Treating Patients With Progressive Prostate Cancer and Bone Metastases
A Phase 2 study testing Tandutinib in people with Metastatic Cancer and Pain, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
RATIONALE: Tandutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well tandutinib works in treating patients with progressive prostate cancer and bone metastases. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Cancer, Pain, Prostate Cancer
- What is being tested?
- Tandutinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Nov 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate.
- Patients must have radiological evidence of bone metastases.
- Patients must have a castrate level of testosterone (</= 50ng/ml). For patients who are medically castrated, luteinizing hormone releasing hormone analog must continue to maintain testicular suppression.
- Patients must have evidence of progressive disease (e.g. progressive bone pain from bone metastases, increasing bidimensional disease on clinical examination or X-rays or appearance of new lesions on bone radiographs). Alternatively, for patients without such evidence of progression, PSA-progression is defined by 2 consecutive rises in prostate-specific antigen (PSA), each an absolute change of at least 1ng/ml, measured at least 2 weeks apart.
- A minimum PSA >/= 5ng/ml is required.
- Patients on anti-androgens should be discontinued from such therapy for at least 4 weeks (for bicalutamide for at least 6 weeks), unless there is interim evidence of progression as defined in Inclusion #4.
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- Patients must have had one prior taxane-based regimen but no prior known PDGFR, platelet-derived growth factor receptor, inhibitor (e.g. imatinib, SU11248, BAY43-9006) therapy is permitted.
- Age >/= 18 years. Because no dosing or adverse event data are currently available on the use of TANDUTINIB in patients < 18 years of age, children are excluded from this study.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patients must have adequate organ and marrow function as follows: leukocytes >/= 3,000/mcL; absolute neutrophil count >/= 1,500/mcL; platelets >/= 100,000/mcL; total bilirubin within normal institutional limits; aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) </= 2.5 times institutional upper limit of normal; creatinine within normal institutional limits OR creatinine clearance >/= 40 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- The effects of TANDUTINIB on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because receptor tyrosine kinase inhibitors are known to be teratogenic, men must agree to use adequate contraception (hormonal or barrier method of birth control, or abstinence) prior to study entry and for 3 months after completion of study therapy.
- Ability to understand and the willingness to sign a written informed consent document.
- Men of all races and ethnic groups are eligible for this trial. This is a study in prostate cancer and is therefore not applicable to women.
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from dose-limiting adverse events due to agents administered more than 4 weeks earlier.
- Patients may not be receiving any other investigational agents or hormonal therapy besides that used to maintain medical castration. Glucocorticoid therapy for intercurrent medical illnesses such as asthma, Chronic Obstructive Pulmonary Disease (COPD) or rheumatoid arthritis flare will be allowed.
- Patients may not be co-medicated with an agent that causes QTc prolongation.
- Patients with a mean QTc >500msec (with Bazett's correction) in screening electrocardiogram or history of familial long QT syndrome are ineligible.
- Left ventricular ejection fraction (LVEF) <40%.
- Myocardial infarction within 6 months of enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
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- Ongoing vomiting, or nausea >/= Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v3.0). If nausea, or vomiting is controlled with therapy (and therefore not Grade 2) such patients may be enrolled.
- Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow pills or absorb oral medications are excluded.
- History of chronic liver disease.
- Known or suspected primary muscular or neuromuscular disease (e.g., muscular dystrophy, myasthenia gravis).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to tandutinib. Patients who develop an acneiform/maculopustular rash while taking either gefitinib or erlotinib should not be prevented from receiving tandutinib unless the rash is considered an allergic reaction (angioedema/urticaria) or Stevens-Johnson syndrome.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infections defined as requiring IV antibiotics on Day 1 of treatment or psychiatric illness/social situations that would limit compliance with study requirements.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with TANDUTINIB. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Trial locations and contacts
1 site in 1 country.
United States1 site
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
About this study
Official title: A Phase II Study of Tandutinib (MLN518) in Androgen-Independent Prostate Cancer With Bone Metastases
RATIONALE: Tandutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well tandutinib works in treating patients with progressive prostate cancer and bone metastases.
Read the detailed description
OBJECTIVES:
Primary
- Determine the time to progression in patients with progressive androgen-independent prostate cancer with bone metastases treated with tandutinib.
Secondary
- Determine the prostate-specific antigen (PSA) decline rate by 50% (PSA response), using the PSA Working Group Criteria, in patients treated with this regimen .
- Evaluate modulation of bone pain and bone markers in patients treated with this regimen.
- Determine the objective tumor response by RECIST (Response Evaluation Criteria In Solid Tumors) criteria in patients treated with this regimen.
- Determine the qualitative and quantitative toxicity of this regimen in these patients.
OUTLINE: Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Bone pain is assessed at baseline, on day 1 of course 3, and at disease progression.
After completion of study treatment, patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
- Conditions
- Metastatic Cancer, Pain, Prostate Cancer
- Being tested
- Tandutinib
- Keywords
- Tandutinib, MLN518, CT53518, pain, adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer, bone metastases, hormone-based castration
- Medical subject headings
- Neoplasm Metastasis, Pain, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TandutinibDrug
Also called CT53518
500 mg twice daily every day with doses taken approximately 12 hours apart, 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Tandutinib (MLN518) | Experimental | 500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases. Tandutinib (MLN518) previously known as CT53518. Receives: Drug: Tandutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
8-week Freedom-From-Progression (FFP)
Simon 2 stage design for freedom from progression at 8 weeks where time-to-progression defined as time of initiation of therapy to first determination of progression of disease by clinical, radiological or serological criteria: Frequency of p-PDGFR (phosphorylated platelet-derived growth factor receptor) expression in bone marrow biopsy specimens, prostate-specific antigen (PSA) declines by 50% sustained for 4 weeks, measurable disease outcomes by RECIST (Response Evaluation Criteria In Solid Tumors) criteria, and quantitative/qualitative toxicities assessed.
Measured: 8 weeks; repeat assessments performed every 8 weeks after criteria for response first met.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Paul Mathew, MD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390468
- Sponsor's protocol ID
- NCI-2012-02865
- Other IDs
- P30CA016672, MDA-2005-0717, NCI-7409, CDR0000504104
- Status last verified
- Jan 2013
- First submitted
- 18 Oct 2006
- Last updated
- 28 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mathew P, Tannir N, Tu SM, Wen S, Guo CC, Marcott V, Bekele BN, Pagliaro L. Accelerated disease progression in prostate cancer and bone metastases with platelet-derived growth factor receptor inhibition: observations with tandutinib. Cancer Chemother Pharmacol. 2011 Oct;68(4):889-96. doi: 10.1007/s00280-011-1567-2. Epub 2011 Feb 3.
PubMed 21290244
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Tandutinib (MLN518) in Androgen-Independent Prostate Cancer With Bone Metastases
- ClinicalTrials.gov ID
- NCT00390468
- Acronym / sponsor ID
- NCI-2012-02865
- Conditions
- Metastatic Cancer, Pain, Prostate Cancer
- Keywords
- Tandutinib, MLN518, CT53518, pain, adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer, bone metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Oct 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 19 Oct 2006 (estimated)
- Results
- Posted 7 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Tandutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well tandutinib works in treating patients with progressive prostate cancer and bone metastases.
Detailed description
OBJECTIVES:
Primary
- Determine the time to progression in patients with progressive androgen-independent prostate cancer with bone metastases treated with tandutinib.
Secondary
- Determine the prostate-specific antigen (PSA) decline rate by 50% (PSA response), using the PSA Working Group Criteria, in patients treated with this regimen .
- Evaluate modulation of bone pain and bone markers in patients treated with this regimen.
- Determine the objective tumor response by RECIST (Response Evaluation Criteria In Solid Tumors) criteria in patients treated with this regimen.
- Determine the qualitative and quantitative toxicity of this regimen in these patients.
OUTLINE: Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Bone pain is assessed at baseline, on day 1 of course 3, and at disease progression.
After completion of study treatment, patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tandutinib (MLN518) | Experimental | Drug: Tandutinib500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases. Tandutinib (MLN518) previously known as CT53518. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate.
- Patients must have radiological evidence of bone metastases.
- Patients must have a castrate level of testosterone (</= 50ng/ml). For patients who are medically castrated, luteinizing hormone releasing hormone analog must continue to maintain testicular suppression.
- Patients must have evidence of progressive disease (e.g. progressive bone pain from bone metastases, increasing bidimensional disease on clinical examination or X-rays or appearance of new lesions on bone radiographs). Alternatively, for patients without such evidence of progression, PSA-progression is defined by 2 consecutive rises in prostate-specific antigen (PSA), each an absolute change of at least 1ng/ml, measured at least 2 weeks apart.
- A minimum PSA >/= 5ng/ml is required.
Key exclusion criteria (14 listed)
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from dose-limiting adverse events due to agents administered more than 4 weeks earlier.
- Patients may not be receiving any other investigational agents or hormonal therapy besides that used to maintain medical castration. Glucocorticoid therapy for intercurrent medical illnesses such as asthma, Chronic Obstructive Pulmonary Disease (COPD) or rheumatoid arthritis flare will be allowed.
- Patients may not be co-medicated with an agent that causes QTc prolongation.
- Patients with a mean QTc >500msec (with Bazett's correction) in screening electrocardiogram or history of familial long QT syndrome are ineligible.
- Left ventricular ejection fraction (LVEF) <40%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TandutinibAlso: CT53518500 mg twice daily every day with doses taken approximately 12 hours apart, 28 day cycle. | Drug | Tandutinib (MLN518) |
Primary outcome
8-week Freedom-From-Progression (FFP)
Time frame: 8 weeks; repeat assessments performed every 8 weeks after criteria for response first met.
Simon 2 stage design for freedom from progression at 8 weeks where time-to-progression defined as time of initiation of therapy to first determination of progression of disease by clinical, radiological or serological criteria: Frequency of p-PDGFR (phosphorylated platelet-derived growth factor receptor) expression in bone marrow biopsy specimens, prostate-specific antigen (PSA) declines by 50% sustained for 4 weeks, measurable disease outcomes by RECIST (Response Evaluation Criteria In Solid Tumors) criteria, and quantitative/qualitative toxicities assessed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21290244Mathew P, Tannir N, Tu SM, Wen S, Guo CC, Marcott V, Bekele BN, Pagliaro L. Accelerated disease progression in prostate cancer and bone metastases with platelet-derived growth factor receptor inhibition: observations with tandutinib. Cancer Chemother Pharmacol. 2011 Oct;68(4):889-96. doi: 10.1007/s00280-011-1567-2. Epub 2011 Feb 3.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Mathew, MD study chair
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tandutinib in people with Metastatic Cancer and Pain, run by National Cancer Institute (NCI) 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 13 inclusion and 14 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 28 May 2014. 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 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?
Yes. Results are posted in the registry (first posted 7 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
8-week Freedom-From-Progression (FFP) (time frame: 8 weeks; repeat assessments performed every 8 weeks after criteria for response first met.). 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 NCT00390468, which also lists 1 linked publication.
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 28 May 2014.