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Hormone Refractory Prostate CancerPhase 2PROACTNCT01215799

Study of Bafetinib (INNO-406) as Treatment for Patients With Hormone-Refractory Prostate Cancer

A Phase 2 study testing Bafetinib in people with Hormone Refractory Prostate Cancer, run by CytRx 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

This is a Phase II open-label study evaluating the preliminary efficacy and safety of bafetinib administered as 240 mg orally twice daily in subjects with Hormone Refractory Prostate Cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Hormone Refractory Prostate Cancer
What is being tested?
Bafetinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
Aug 2010to Dec 2011
Phase
Phase 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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males age ≥18 years.
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate.
  • Hormone-refractory prostate cancer having progressed despite androgen deprivation therapy that resulted in a castrated level of testosterone (<50 ng/dL) or orchiectomy; with or without evidence of measurable or evaluable disease.
  • PSA increase defined as 2 consecutive rises; first increase in PSA occurred a minimum of 1 week from the reference value; increase in PSA should be at least 25% above the reference value and absolute PSA value should be >5 ng/mL.
  • May have received no more than 1 prior chemotherapy regimen. Prior immunomodulatory therapy (sipuleucel-t (Provenge), interferon) is allowed.
  • Must be taking a single agent LHRH agonist or antagonist, unless previously underwent orchiectomy.
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  • ECOG performance status 0-2.
  • Able to swallow pills.
  • Able to provide written, voluntary informed consent, comply with trial procedures, and have accessibility to the site.

Who cannot join

  • Chemotherapy, antibody therapy, major surgery or irradiation within 4 weeks of study enrollment
  • Exposure to any investigational agent within 30 days of the Screening Visit.
  • No prior flutamide (Eulexin) and ketoconazole use within 4 weeks, bicalutamide (Casodex) within 6 weeks or nilutamide (Nilandron) within 6 weeks of study enrollment.
  • Use of Quadramet therapy during 2 months prior to study enrollment or Metastron ever.
  • Prior treatment with a tyrosine kinase inhibitor.
  • Subjects who have started bisphosphonate therapy within 4 weeks of study enrollment are excluded. Subjects treated with a stable dose of a bisphosphonate for >4 weeks and the tumor has still progressed can be enrolled in the study.
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  • Known CNS disease or CNS metastases.
  • History of other malignancies within the last five years except curatively treated basal cell carcinoma or superficial bladder cancer.
  • Laboratory values: Screening serum creatinine greater than or equal to 1.5 x ULN, alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, total bilirubin greater than 3 times the upper limit of normal, white blood cell (WBC) count <3500/mm3, absolute neutrophil count <1500/mm3, hematocrit level <35% and platelets <100,000/mm3.
  • History of abnormal bleeding or use of anticoagulant therapy.
  • Clinically evident congestive heart failure >class II of the New York Heart Association (NYHA) guidelines.
  • Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
  • History of MI within 6 months or uncontrolled angina within 3 months.
  • Severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, chronic renal disease, chronic liver disease.
  • Known HIV infection.
  • Uncontrolled active, infection.
  • Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
  • Any condition that in the opinion of the Investigator is unstable and could jeopardize the subject's participation in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: A Phase II Study of Bafetinib (INNO-406) as Treatment for Patients With Hormone-Refractory Prostate Cancer

This is a Phase II open-label study evaluating the preliminary efficacy and safety of bafetinib administered as 240 mg orally twice daily in subjects with Hormone Refractory Prostate Cancer.

Being tested
Bafetinib
Keywords
Hormone Refractory Prostate Cancer, HRPC

What participants receive

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

  • BafetinibDrug

    Also called INNO-406

    Bafetinib 240 mg bid

Study groups in NCT01215799
Study groupRoleWhat they receive
BafetinibExperimentalNot described
Receives: Drug: Bafetinib

What is being measured

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

  1. Objective Response Rate

    The primary objective of this study is to determine the preliminary efficacy of administration of bafetinib in subjects with hormone-refractory prostate cancer (HRPC), as measured by the objective response rate (ORR), which is a combination of CR (PSA ≤0.12 ng/mL) and PR (≥50% reduction in PSA from baseline).

    Measured: At six months.

Secondary outcomes (3)

  1. Safety

    The safety of bafetinib in this population assessed by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, and vital signs.

    Measured: At six months.

  2. Progression-free survival

    Progression-free survival is defined as the time from enrollment to first documentation of objective PSA or tumor progression, or to death due to any cause in the absence of previous documentation of objective tumor progression.

    Measured: At six months.

  3. Objective tumor response

    The total proportion of subjects who have an objective tumor reponse (CR + PR) using the RECIST criteria.

    Measured: At six months.

Timeline

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

  1. First posted7 Oct 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionSep 2011
  4. Study completionDec 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01215799
Sponsor's protocol ID
BAFETINIB-P2-HRPC-01
Acronym
PROACT
Status last verified
Dec 2011
First submitted
30 Sep 2010
Last updated
15 Dec 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bafetinib in people with Hormone Refractory Prostate Cancer, run by CytRx 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 9 inclusion and 18 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 15 Dec 2011. 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?

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?

Objective Response Rate (time frame: At six 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 NCT01215799.

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 15 Dec 2011.

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