Prior Treatment With PD-0325901 With Ongoing Clinical ResponseNCT02297802
A Single Patient IND for PD-0325901
A study testing PD-0325901 in people with Prior Treatment With PD-0325901 With Ongoing Clinical Response, run by Sharp HealthCare at 1 site in United States.
Trial summary
The purpose of this study is to provide access for a single patient to PD-0325901 who was previously enrolled in a phase I clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prior Treatment With PD-0325901 With Ongoing Clinical Response
- What is being tested?
- PD-0325901
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jul 2013
- Phase
- Expanded access
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior treatment with PD-0325901 with ongoing response
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Single Patient IND for PD-0325901
The purpose of this study is to provide access for a single patient to PD-0325901 who was previously enrolled in a phase I clinical trial.
- Being tested
- PD-0325901
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-0325901Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startJun 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prior Treatment With PD-0325901 With Ongoing Clinical ResponseStudies of the same condition, open and under way.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297802
- Sponsor's protocol ID
- 130596 SHRP
- Status last verified
- Nov 2014
- First submitted
- 12 May 2014
- Last updated
- 26 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single Patient IND for PD-0325901
- ClinicalTrials.gov ID
- NCT02297802
- Acronym / sponsor ID
- 130596 SHRP
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to provide access for a single patient to PD-0325901 who was previously enrolled in a phase I clinical trial.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prior treatment with PD-0325901 with ongoing response
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| PD-0325901 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PD-0325901 in people with Prior Treatment With PD-0325901 With Ongoing Clinical Response, run by Sharp HealthCare 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Nov 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.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
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 26 Nov 2014.