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Prostate NeoplasmsPhase 1NCT01228760

A Study to Determine the Maximum Tolerated Dose of ASG-5ME in Subjects With Castration-Resistant Prostate Cancer

A Phase 1 study testing ASG-5ME in people with Prostate Neoplasms, run by Astellas Pharma Inc at 4 sites 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

The purpose of this dose escalation study is to determine the Maximum Tolerated Dose (MTD) and the recommended Phase 2 dose of ASG-5ME in subjects with castration-resistant prostate cancer (CRPC). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Neoplasms
What is being tested?
ASG-5ME
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
4 sitesUnited States
Study dates
Oct 2010to Feb 2013
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has histologically-confirmed castration-resistant prostate cancer and meets at least 1 of the following criteria:
  • subject's disease has progressed on or after available standard therapy -OR-
  • there is no effective standard therapy available for treating the subject's disease -OR-
  • subject or his disease is not suitable for standard therapy -OR-
  • subject chooses to defer or decline standard therapy (subject is adequately informed of the availability of clinically meaningful therapy and chooses instead to partake in this research using a product with no documented clinical activity)
  • Testosterone ≤ 50 ng/dL
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of > 6 months as evaluated and documented by the investigator
  • Hematologic function, as follows (no red blood cell (RBC) or platelet transfusions are allowed within 4 weeks of the first dose of ASG-5ME):
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelet count ≥ 100 x 109/L
  • Hemoglobin ≥ 9 g/dL
  • Renal function, as follows: creatinine ≤ 1.5 x upper limit of normal (ULN), or creatinine clearance of > 60 mL/min if serum creatinine is > 2.0 mg/dL
  • Total bilirubin < 1. 5 x ULN
  • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT)≤ 1.5 x ULN
  • International Normalized Ratio (INR) < 1.3 (or < 3.0 if on therapeutic anticoagulation)
  • Serum calcium ≤ ULN
  • Subjects must be taking and agree to remain on a stable dose of luteinizing hormone-releasing hormone (LHRH) agonist therapy or gonadotropin-releasing hormone (GnRH) antagonist for the duration of the trial if not surgically castrated
  • Additional Inclusion criteria for Chemotherapy Naïve Cohort: No prior systemic cytotoxic chemotherapies
  • Additional Inclusion criteria for Chemotherapy Exposed Cohort:
  • Documented disease progression during or after docetaxel treatment or intolerability to docetaxel treatment
  • No additional prior chemotherapy for CRPC is allowed

Who cannot join

  • History of central nervous system metastasis, including incompletely treated epidural disease
  • History of other primary malignancy (including premalignant myeloid malignancy e.g. myelodysplastic syndrome), unless:
  • Curatively resected non-melanomatous skin cancer
  • Other malignancy curatively treated with no known active disease present and no treatment administered for the last 3 years
  • Active angina or Class III or IV Congestive Heart Failure (CHF) (New York Heart Association CHF Functional Classification System) or clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, congestive heart failure, uncontrolled hypertension, or arrhythmias not controlled by outsubject medication
  • The following treatments are not allowed within 4 weeks of enrollment: cytotoxic chemotherapy, radiation therapy or the dietary supplement PC-SPES
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  • Use of prednisone (or equivalent corticosteroids) > 20 mg/day are not allowed. Doses < 20 mg/day are allowed only if they have been at the same dose for > 4 weeks
  • Use of anti-androgen therapy (ie, flutamide, bicalutamide and nilutamide) within 6 weeks of study enrollment; non-responders to second-line anti-androgen therapy do not require the 6 week withdrawal period
  • Monoclonal antibody therapy within 3 months of enrollment with the exception of denosumab (prior or concurrent use of denosumab is allowed)
  • Peripheral neuropathy of ≥ grade 2 as defined by the CTCAE criteria version 4.0
  • Major surgery (that requires general anesthesia) within 4 weeks of study enrollment
  • Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening
  • Use of any investigational drug (including marketed drugs not approved for this indication) within 30 days prior to enrollment
  • History of thromboembolic events and bleeding disorders ≤ 3 months (e.g., deep vein thrombosis (DVT) or pulmonary embolism (PE))
  • Known positive test for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B surface antigen

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • The Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21205

  • The Karmanos Cancer Institute

    Detriot, Michigan, 48201

  • University of Wisconsin Madison, Carbone Cancer Center

    Madison, Wisconsin, 53705

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of ASG-5ME Monotherapy in Subjects With Castration-Resistant Prostate Cancer (CRPC)

The purpose of this dose escalation study is to determine the Maximum Tolerated Dose (MTD) and the recommended Phase 2 dose of ASG-5ME in subjects with castration-resistant prostate cancer (CRPC).

Read the detailed description

The study has two components. The first aims to establish a safe dose of ASG-5ME. Once identified, the safety and preliminary estimate of antitumor activity of ASG-5ME will be tested in additional subjects with castration-resistant prostate cancer (CRPC) who are either chemotherapy naïve or chemotherapy exposed in expanded cohorts.

Being tested
ASG-5ME
Keywords
Castration-Resistant Prostate Cancer, ASG-5ME, Pharmacokinetics of ASG-5ME
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • ASG-5MEDrug

    IV

Study groups in NCT01228760
Study groupRoleWhat they receive
Dose level 1ExperimentalNot described
Receives: Drug: ASG-5ME
Dose level 2ExperimentalNot described
Receives: Drug: ASG-5ME
Dose level 3ExperimentalNot described
Receives: Drug: ASG-5ME
Dose level 4ExperimentalNot described
Receives: Drug: ASG-5ME
Dose level 5ExperimentalNot described
Receives: Drug: ASG-5ME
Dose level 5AExperimentalNot described
Receives: Drug: ASG-5ME
Dose level 6ExperimentalNot described
Receives: Drug: ASG-5ME
Dose level 7ExperimentalNot described
Receives: Drug: ASG-5ME
Dose level 8ExperimentalNot described
Receives: Drug: ASG-5ME
Dose level 9ExperimentalNot described
Receives: Drug: ASG-5ME
Chemotherapy-naïve subjectsExperimentalNot described
Receives: Drug: ASG-5ME
Chemotherapy exposed subjectsExperimentalNot described
Receives: Drug: ASG-5ME

What is being measured

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

  1. Safety assessed by recording of adverse events, laboratory assessments and vital signs

    Measured: For 12 weeks during treatment period and up to 4 weeks follow up

  2. Pharmacokinetics assessment of ASG-5ME blood levels through analysis of blood samples

    Measured: Up to day 15 for cycle 1 and cycle 4 and pre-dose for cycles 2 and 3; every 3 weeks during the second 12 weeks of treatment; and if subject continues on study drug, every 12 weeks thereafter

Secondary outcomes (6)

  1. Incidence of anti-ASG-5ME antibody formation

    Measured: Baseline; up to day 64 during the first 12 weeks; and if subject continues on study drug, every 3 weeks during the second 12 weeks of treatment and every 12 weeks thereafter

  2. Incidence of tumor response (complete or partial response)

    Measured: Baseline and every 12 weeks while on study drug

  3. Changes in prostate-specific antigen (PSA) levels

    Measured: Baseline; up to day 64 during the first 12 weeks; and if the subject continues on study drug, every 3 weeks thereafter

  4. Changes in bone scans

    Measured: Baseline and every 12 weeks while on study drug

  5. Changes in circulating tumor cells

    Measured: Baseline; up to day 64 during the first 12 weeks; and if the subject continues on study drug, every 3 weeks during the second 12 weeks of treatment and every 12 weeks thereafter

  6. Changes in cytokeratin-18 levels

    Measured: Up to day 79 and 4 weeks after the last dose of study drug

Timeline

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

  1. First posted26 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01228760
Sponsor's protocol ID
ASG-5ME-10-1
Status last verified
Jun 2013
First submitted
21 Oct 2010
Last updated
7 Jun 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASG-5ME in people with Prostate Neoplasms, run by Astellas Pharma Inc at 4 sites 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 22 inclusion and 15 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 7 Jun 2013. 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 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?

Safety assessed by recording of adverse events, laboratory assessments and vital signs (time frame: For 12 weeks during treatment period and up to 4 weeks follow up). The study lists 2 primary outcomes in all. 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 NCT01228760.

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 7 Jun 2013.

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