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Prostate CancerPhase 1/2NCT01240629

Doxorubicin-GnRH Agonist Conjugate AEZS-108 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

A Phase 1/2 study testing laboratory biomarker analysis, questionnaire administration and doxorubicin-GnRH agonist conjugate AEZS-108 in people with Prostate Cancer and Hormone-resistant Prostate Cancer, run by University of Southern California 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 research study for advanced prostate cancer. An experimental drug called AN-152 (also known as AEZS-108) will be used. The purpose of this study is to test the safety, tolerability and benefits of an experimental drug called AN-152. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
laboratory biomarker analysis, questionnaire administration and doxorubicin-GnRH agonist conjugate AEZS-108
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteUnited States
Study dates
2 Nov 2010to 2 Feb 2017
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed prostate cancer
  • Measurable disease on computer tomography (CT) scan or evaluable disease with an elevated prostate specific antigen (PSA)
  • Documented progression on (a) at least one prior hormone treatment, which must have incorporated luteinizing hormone-releasing hormone (LH- RH)agonist therapy AND (b) at least one chemotherapy regimen, which must have been taxane based
  • Progression may be demonstrated by PSA (defined by a 25% increase in the PSA from its most recent treatment nadir, confirmed with a second measurement at least 4 weeks later) or radiologic criteria (defined by radiologic documentation of a new lesion or a >= 20% increase in the sum of the diameters of previously noted measurable lesions)
  • Palliative radiation therapy (RT) for metastatic disease is allowed only if =< 25% of total body bone marrow was irradiated and =< 35Gy administered to the pericardial area
  • 28 days must have elapsed since completion of RT with bone marrow recovery
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  • Soft tissue disease irradiated in the prior 2 months may not be designated as measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
  • Adequate bone marrow function, defined by ANC >= 1000/ul, hemoglobin >= 8.0 g/dL and platelet count >= 75,000/ ul
  • Adequate renal function, defined by serum creatinine =< 1.5x the upper limit of normal (ULN)
  • Adequate hepatic function, defined by bilirubin =< 1.5 mg/dL AND alkaline phosphatase =< 3x ULN for the reference lab (=< 5x ULN for patients with known hepatic metastases and no limit for patients with known bone metastases) AND AST and ALT =< 3x ULN (=< 5x the ULN for patients with known hepatic metastases)
  • Must have recovered from acute and late effects of any prior surgery, radiotherapy or other anti-neoplastic therapy
  • Patients or their legal representatives must be able to read,understand, and provide informed consent
  • Men of childbearing potential must consent to use barrier contraception while on treatment and for 90 days thereafter
  • Willingness to discontinue LH-RH analogue therapy and for the duration of the study

Who cannot join

  • Ongoing use of an LH-RH agonist (or antagonist)
  • Patients who agree to stop LH-RH agonist therapy will be eligible but may need to wait until their required washout period is over
  • Patients whose washout period is more than 6 weeks will not be eligible
  • Duration of washout period varies with the formulation of the LH-RH agonist being used and should be 2 weeks after the next dose would be scheduled. Specifically: a) For patients receiving a monthly formulations of LH-RH agonist, 6 weeks must pass from the last dose before eligibility; b) For patients receiving a 3-month depot formulation of LH-RH agonist, 14 weeks must pass from the last dose before eligibility; c) For patients receiving a 4- month depot formulation of LH-RH agonist, 18 weeks must pass from the last dose before eligibility; d) For patients receiving a 6- month depot formulation of LH-RH agonist, 26 weeks must pass from the last dose before eligibility; e) For patients with an annual LH-RH implant, 2 weeks must pass after removal of the implant before eligibility
  • Presence of an active infection or fever within 3 days of the first scheduled protocol treatment
  • Presence of parenchymal brain metastases
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  • Patients with neurological symptoms must have a CT or magnetic resonance imaging (MRI)scan of the brain showing no metastases within 60 days of enrollment
  • History of prior malignancy within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or superficial bladder
  • Patients with known hypersensitivity to any of the components of AN-152 including doxorubicin and LH-RH agonists
  • Patients who received radiotherapy within 4 weeks of entry
  • Patients who received treatment with strontium-89 or samarium-153 are excluded, except prior samarium will be allowed provided it was administered more than 1 year ago and/or the patient has demonstrated the ability to receive cytotoxic chemotherapy without excess of myelosuppression after receiving samarium.
  • Patients with a history of unstable or newly diagnosed angina pectoris, documented history of current serious arrhythmia or congestive heart failure or recent myocardial infarction (within 6 months of enrollment)
  • Left ventricular ejection fraction (EF) < 50%
  • Prior exposure to anthracyclines or anthracenediones including doxorubicin, daunorubicin, and mitoxantrone
  • Major surgery within the last 2 weeks
  • Receiving concurrent investigational therapy or have received investigational therapy within 30 days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
  • Known HIV or hepatitis B or C infection
  • Life expectancy < 3 months
  • Presence of any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with interpretation of the results
  • Prior treatment with AN-152
  • Lack of ability or willingness to give informed consent
  • Anticipated non-availability for study visits/procedures

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Southern California

    Los Angeles, California, 90033-0804

Other trials in United States

About this study

Official title: A Phase I/II Trial of AN-152 [AEZS-108) in Castration- and Taxane-Resistant Prostate Cancer

This is a research study for advanced prostate cancer. An experimental drug called AN-152 (also known as AEZS-108) will be used. The purpose of this study is to test the safety, tolerability and benefits of an experimental drug called AN-152.

The participants tumor will be tested for expression of this receptor (using an old biopsy). If the participants cancer does not have this receptor, participants will not be eligible to participant in this study.

Read more

AN-152 (AEZS-108) is administered intravenously (IV) over 2 hours and will be given at the specified dose every 3 weeks. Premedication with dexamethasone 8mg is recommended.

Participants will continue treatment until death, disease progression, unacceptable toxicity, participants refusal, treatment delay >3 weeks, or the completion of 6 cycles. Continuation beyond 6 cycles is left at the discretion of the study doctor.

The study is planned to last 2 years. Up to 55 (up to 18 for the Phase I portion, up to 37 for the Phase II portion).

Being tested
laboratory biomarker analysis, questionnaire administration, doxorubicin-GnRH agonist conjugate AEZS-108
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • laboratory biomarker analysisOther

    Correlative study

  • questionnaire administrationOther

    Correlative study

  • doxorubicin-GnRH agonist conjugate AEZS-108Drug

    Also called AEZS-108, doxorubicin-LHRH agonist conjugate AEZS-108

    Given IV

Study groups in NCT01240629
Study groupRoleWhat they receive
Arm IExperimentalPatients receive doxorubicin-GnRH agonist conjugate AEZS-108 intravenously (IV) over 2 hours once every 21 days (21 days = 1 cycle). Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Other: laboratory biomarker analysis; Other: questionnaire administration; Drug: doxorubicin-GnRH agonist conjugate AEZS-108

What is being measured

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

  1. Clinical benefit defined as non-progression with no dose-limiting toxicity or other toxicity requiring termination of treatment

    Measured: At 3 months up to 24 months

Secondary outcomes (6)

  1. Time to overall disease progression

    Measured: Up to 24 months

  2. Response for patients with measurable disease based on the Response Evaluation Criteria in Solid Tumors (RECIST)

    Measured: At 3 months up to 24 months

  3. To assess the prostate specific antigen (PSA) response rate in patients treated with AN-152

    Measured: At 3 months up to 24 months

  4. Time to PSA progression

    Measured: Up to 24 months

  5. Number of participants with adverse events as a measure of safety and tolerability

    Measured: At 3 weeks up to 72 weeks

  6. Overall survival

    Measured: Up to 2 years

Timeline

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

  1. First posted15 Nov 2010 (estimated)
  2. Study start2 Nov 2010
  3. Primary completion2 Feb 2017
  4. Study completion2 Feb 2017

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01240629
Sponsor's protocol ID
4P-09-9
Other IDs
NCI-2009-01418
Status last verified
Jul 2017
First submitted
30 Jun 2010
Last updated
11 Jul 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing laboratory biomarker analysis, questionnaire administration and doxorubicin-GnRH agonist conjugate AEZS-108 in people with Prostate Cancer and Hormone-resistant Prostate Cancer, run by University of Southern California 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 15 inclusion and 22 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 11 Jul 2017. 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 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 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?

Clinical benefit defined as non-progression with no dose-limiting toxicity or other toxicity requiring termination of treatment (time frame: At 3 months up to 24 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 NCT01240629.

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 11 Jul 2017.

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