This study has been transitioned to CTIS with ID 2023-510298-33-00 check the CTIS register for the current data. The objective of the study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment…
ID
Source
Brief title
Condition
- Other condition
- Metastases
Synonym
Health condition
prostate cancer metastatic
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The objective of the study is to collect long term safety data in subjects who
are continuing to derive clinical benefit from treatment with Enzalutamide (as
assessed by the investigator) from their participation in an enzalutamide
clinical study sponsored by Astellas or Medivation, Inc., a wholly owned
subsidiary of Pfizer Inc. (Medivation/Pfizer) which has completed, at a
minimum, the primary analysis or the study specified evaluation period.
Subjects should continue on the treatment regimen that they were receiving in
the study they are enrolling from until any of the discontinuation criteria are
met as outlined below. Dose changes of any of the prior therapies subjects were
receiving on the previous protocol are allowed after medical monitor approval:
monotherapy with enzalutamide or any dose change of the combination compound
and background therapy. If enzalutamide is discontinued from a combination
therapy, subject is to be taken off the study.
Secondary outcome
N/A
Background summary
Enzalutamide is a drug that is used to treat prostate cancer.
Enzalutamide blocks the action of the androgen receptor (AR) which is a cell
receptor. Cell receptors are a type of protein that acts like locks on the
surface of a cell that cause further chemical reaction inside of a cell.
Sometimes in cancer, there are too many of these receptors compared to normal
cells or these reactions happen more often than normal and lead to tumor cell
growth.
Blocking of the androgen receptor has been important in prostate cancer to
delay tumors from growing.
Study objective
This study has been transitioned to CTIS with ID 2023-510298-33-00 check the CTIS register for the current data.
The objective of the study is to collect long term safety data in subjects who
are continuing to derive clinical benefit from treatment with Enzalutamide (as
assessed by the investigator) from their participation in an enzalutamide
clinical study sponsored by Astellas or Medivation, Inc., a wholly owned
subsidiary of Pfizer Inc. (Medivation/Pfizer) which has completed, at a
minimum, the primary analysis or the study specified evaluation period.
Study design
This is a multicenter, international, open-label extension study for subjects
who are currently enrolled in a clinical trial receiving enzalutamide for
treatment of their prostate cancer and who are continuing to derive clinical
benefit at the termination of that trial, based on the assessment of the
investigator. The investigator may proceed to roll-over a study subjects as
long as subjects meet all entry criteria and if it is considered the best
option for the subjects. Subjects must continue on the treatment regimen that
they were receiving in the prior study. Dose changes of any of the prior
therapies subjects were receiving on the previous protocol are allowed after
medical monitor approval: monotherapy with enzalutamide or any dose change of
the combination compound and background therapy.
Upon Institutional Review Board (IRB)/ Independent Ethics Committee (IEC)
approval of the protocol, the subject will be asked for consent for this study
and all required procedures will be completed. The day 1 visit for this study
should coincide with the last treatment visit for the study the subject will be
enrolling from (<= 7 days post last visit of parent study). The subject will be
instructed to return all study medication from the parent study at the final
visit, and if eligible, will receive enzalutamide for this study on day 1.
The subjects will be followed according to the local institution*s standard of
care and will be required to return to the institution every 24 weeks (± 7
days) to review adverse events (AEs), collect concomitant medications and,
confirm that no discontinuation criteria are met. At each visit and at every 12
weeks (IP only visit) subjects are to return all dispensed study drug and to
receive more study drug if applicable.
Telemedicine visits may be allowed due to specific circumstances. For visits
done via telemedicine, delivery of further IP can be arranged with direct to
subject shipment services.
The study subjects will continue to receive treatment until any of the
discontinuation criteria are met. An end of study visit will be performed 30
days (±7 days) after the last dose of enzalutamide or prior to the initiation
of another systemic anticancer therapy, whichever occurs first.
Intervention
Subjects will receive 160 mg (4 capsules) of enzalutamide orally once daily at
the same time each day.
Subjects who experience a grade 3 or higher toxicity that is attributed to the
study drug and cannot be ameliorated by the use of adequate medical
intervention and/or dose reduction may interrupt study drug treatment for 1
week or until the toxicity grade improves to grade 2 or lower in severity.
Study drug may be restarted at the subject*s initial dose at Day 1 or at a
reduced dose (i.e., 120 mg or 80 mg/day) in consultation with the Medical
Monitor. If co-administration of strong CYP2C8 inhibitor is discontinued, the
enzalutamide dose should return to the dose used prior to initiation of the
strong CYP2C8 inhibitor.
Study burden and risks
Enzalutamide may help with cancer prostate regression, but it is not certain.
Participation may provide new information which may benefit cancer prostate
patients in the future. It is hoped that information gained in this study will
aid in the understanding of cancer and help in the development of new
approaches to its treatment.
Disadvantages of participation in the study may be:
• possible side effects/complications of your prostate cancer;
Astellas Pharma Global Development, Inc. (APGD) 1 Astellas Way
Northbrook 60062 IL
US
Astellas Pharma Global Development, Inc. (APGD) 1 Astellas Way
Northbrook 60062 IL
US
Listed location countries
Age
Inclusion criteria
1. IRB/IEC approved written Informed Consent and privacy language as per
national regulations [e.g., Health Insurance Portability and Accountability Act
authorization for the United States sites] must be obtained from the subject
prior to any study-related procedures.
2. Subject must currently be receiving enzalutamide for prostate cancer in a
study sponsored by Astellas or Medivation/Pfizer and based on the
investigator*s assessment, benefit from continued treatment. Subjects
participating in investigator-initiated trials are not eligible.
3. Subjects are able to continue on the treatment regimen that they were
receiving in the prior study. If in the investigator*s assessment a change is
needed to the subject*s regimen approval (e.g., dose change in androgen
deprivation therapy (ADT) or dropping of a combination therapy) approval from a
medical monitor is required prior to enrollment.
4. Subject is able to swallow enzalutamide capsules and comply with study
requirements.
5. Subject and his female partner who is of childbearing potential must
continue to use 2 forms of birth control, of which 1 must be highly effective*
and 1 must be a barrier method* throughout the study and for 3 months after
final enzalutamide administration.
Two acceptable forms of birth control include:
* Condom (barrier method of contraception), AND
* In addition to a condom, 1 of the following acceptable forms of contraception
is required:
* Established use of oral, injected or implanted hormonal methods of
contraception * Placement of an intrauterine device or intrauterine system
* Tubal ligation
* Vasectomy or other surgical castration prior to initial screening.
6. Subject agrees to avoid sperm donation during the study and for at least 3
months after final enzalutamide administration.
7. Subject agrees not to participate in another interventional study while on
treatment. Waivers to the inclusion criteria will NOT be allowed
Exclusion criteria
1. Subject met any of the discontinuation criteria or progressed on the current
enzalutamide clinical study in which they are enrolling from.
2. Subject requires treatment with or plans to use either of the following:
* New systemic therapy for their cancer (palliative radiation therapy is
allowed). The treatment with agents administered during previous studies which
was stopped and then restarted during this study does not represent new
treatment (e.g., ADT).
* Investigational therapy other than enzalutamide
3. Subject is currently participating in an investigator-initiated
interventional trial and receiving enzalutamide.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-510298-33-00 |
| EudraCT | EUCTR2016-001694-32-NL |
| ClinicalTrials.gov | NCT02960022 |
| CCMO | NL80332.068.22 |