Hematologic NeoplasmsPhase 1NCT00900614
Safety Study of APR-246 in Patients With Refractory Hematologic Cancer or Prostate Cancer
A Phase 1 study testing APR-246 in people with Hematologic Neoplasms and Prostatic Neoplasms, run by Aprea Therapeutics at 6 sites in Sweden.
Trial summary
The purpose of this study is to determine the highest feasible dose (HFD) of intravenous (IV) APR-246 when given to patients with refractory hematologic malignancies or prostate carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Neoplasms, Prostatic Neoplasms
- What is being tested?
- APR-246
- Type of treatment
- Injection or infusion
- How many people
- 36 participants
- Where
- 6 sitesSweden
- Study dates
- May 2009to Oct 2010
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age.
- Any below mentioned advanced disease, which is not eligible for other therapies. The diagnosis should have been confirmed either histologically or cytologically:
- Acute myeloid leukemia.
- Acute lymphoid leukemia.
- Chronic lymphocytic leukemia.
- Chronic myeloid leukemia.
Show all 13Show fewer
- Chronic myelomonocytic leukemia.
- Multiple myeloma.
- Non Hodgkin's lymphoma.
- Hodgkin's lymphoma.
- Myelodysplastic syndrome.
- Myelofibrosis.
- Hormone refractory, metastatic prostate carcinoma.
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Sweden6 sites
Section of Haematology and Coagulation, Sahlgrenska University Hospital
Gothenburg, 41345
Department of Hematology, University Hospital
Örebro, 70185
Urology clinic, University Hospital
Örebro, 70185
Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge
Stockholm, SE 141 86
Clinical Research and Development Unit, Department of Oncology, Akademiska Hospital
Uppsala, 75185
Department of Haematology, Akademiska Hospital
Uppsala, 75185
About this study
Official title: An Open-label Phase I Dose Escalating Study of APR-246 for Infusion in Patients With Refractory Hematologic Malignancies or Prostate Carcinoma
The purpose of this study is to determine the highest feasible dose (HFD) of intravenous (IV) APR-246 when given to patients with refractory hematologic malignancies or prostate carcinoma.
- Conditions
- Hematologic Neoplasms, Prostatic Neoplasms
- Being tested
- APR-246
- Keywords
- Hematologic malignancy, Prostate carcinoma, Hematologic cancer, Prostate cancer
- Medical subject headings
- Hematologic Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APR-246Drug
Intravenous infusion. Dose escalating. Dosing will be conducted with three patients at each dose level.
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT) is reached and HFD is defined accordingly, OR the dose, which is expected to result in maximum plasma concentration close to, but not exceeding 35 μg/ml in any single patient without showing signs of DLT.
Measured: 21 days
Secondary outcomes (2)
Determination of the toxicity and safety profile of APR-246 based on safety parameters from the entire study period.
Measured: continuously during 21 days
Determination of the PK profile for up to 22 hours after the last APR-246 infusion. Cmax (maximal plasma concentration), AUC (area under the curve), t1/2 (half-life) and clearance will be determined.
Measured: continuously, during 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic NeoplasmsStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aprea Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sören Lehmann, MD, PhD, Principal investigator, Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge, SE-141 86, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900614
- Sponsor's protocol ID
- APR-246-01
- Status last verified
- Jul 2019
- First submitted
- 11 May 2009
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase I Dose Escalating Study of APR-246 for Infusion in Patients With Refractory Hematologic Malignancies or Prostate Carcinoma
- ClinicalTrials.gov ID
- NCT00900614
- Acronym / sponsor ID
- APR-246-01
- Conditions
- Hematologic Neoplasms, Prostatic Neoplasms
- Keywords
- Hematologic malignancy, Prostate carcinoma, Hematologic cancer, Prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Aprea TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 13 May 2009 (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 determine the highest feasible dose (HFD) of intravenous (IV) APR-246 when given to patients with refractory hematologic malignancies or prostate carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female ≥ 18 years of age.
- Any below mentioned advanced disease, which is not eligible for other therapies. The diagnosis should have been confirmed either histologically or cytologically:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| APR-246Intravenous infusion. Dose escalating. Dosing will be conducted with three patients at each dose level. | Drug | – |
Primary outcome
Dose-Limiting Toxicity (DLT) is reached and HFD is defined accordingly, OR the dose, which is expected to result in maximum plasma concentration close to, but not exceeding 35 μg/ml in any single patient without showing signs of DLT.
Time frame: 21 days
2 secondary outcomes
Determination of the toxicity and safety profile of APR-246 based on safety parameters from the entire study period.
Time frame: continuously during 21 days
Determination of the PK profile for up to 22 hours after the last APR-246 infusion. Cmax (maximal plasma concentration), AUC (area under the curve), t1/2 (half-life) and clearance will be determined.
Time frame: continuously, during 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
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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.
Sören Lehmann, MD, PhD principal investigator
Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge, SE-141 86, Stockholm, Sweden
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APR-246 in people with Hematologic Neoplasms and Prostatic Neoplasms, run by Aprea Therapeutics at 6 sites in Sweden.
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 13 inclusion and 0 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 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden. 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?
Dose-Limiting Toxicity (DLT) is reached and HFD is defined accordingly, OR the dose, which is expected to result in maximum plasma concentration close to, but not exceeding 35 μg/ml in any single patient without showing signs of DLT. (time frame: 21 days). It is what the study was designed to measure, not a finding.
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 31 Jul 2019.