Leukemia, MyeloidPhase 1/2NCT00233909
A Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia
A Phase 1/2 study testing Zosuquidar and gemtuzumab ozogamicin in people with Leukemia, Myeloid, run by Kanisa Pharmaceuticals.
Trial summary
Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help Gemtuzumab Ozogamicin (GO) kill more cancer cells by making cancer cells more sensitive to the drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid
- What is being tested?
- Zosuquidar and gemtuzumab ozogamicin
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Mar 2008
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Morphologic evidence of acute myeloid leukemia in first relapse.
- Phase I: 18 years or older, Phase II: 50 years or older
Who cannot join
- Prior treatment with zosuquidar
- Any investigational agent within 1 month of enrollment and lack of recovery from toxicities secondary to those agents
- History of stem cell transplant
About this study
Official title: An Open-Label, Phase I/II Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia
Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help Gemtuzumab Ozogamicin (GO) kill more cancer cells by making cancer cells more sensitive to the drug. It is not known whether Gemtuzumab Ozogamicin (GO) is more effective with or without zosuquidar in treating acute myeloid leukemia.
Read the detailed description
Purpose:
Phase I: Determine the optimal dose and schedule of GO and zosuquidar when used in combination.
Phase II: Determine the complete remission rate (CR+CRp)
- Conditions
- Leukemia, Myeloid
- Being tested
- Zosuquidar, gemtuzumab ozogamicin
- Keywords
- Leukemia, Myeloid, Relapse, Chemotherapy, Zosuquidar, gemtuzumab ozogamicin (GO)
- Medical subject headings
- Leukemia, Myeloid, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZosuquidarDrug
gemtuzumab ozogamicinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leukemia, MyeloidStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanisa Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233909
- Sponsor's protocol ID
- KAN-979-02
- Status last verified
- Mar 2008
- First submitted
- 4 Oct 2005
- Last updated
- 1 Apr 2008
- Results posted
- No
Publications
Marcelletti JF, Sikic BI. A clinical trial of zosuquidar plus gemtuzumab ozogamicin (GO) in relapsed or refractory acute myeloid leukemia (RR AML): evidence of efficacy based on leukemic blast P-glycoprotein functional phenotype. Cancer Chemother Pharmacol. 2023 Nov;92(5):369-380. doi: 10.1007/s00280-023-04578-9. Epub 2023 Aug 21.
PubMed 37603048
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase I/II Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00233909
- Acronym / sponsor ID
- KAN-979-02
- Conditions
- Leukemia, Myeloid
- Keywords
- Leukemia, Myeloid, Relapse, Chemotherapy, Zosuquidar, gemtuzumab ozogamicin (GO)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Kanisa PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 6 Oct 2005 (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.
Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help Gemtuzumab Ozogamicin (GO) kill more cancer cells by making cancer cells more sensitive to the drug. It is not known whether Gemtuzumab Ozogamicin (GO) is more effective with or without zosuquidar in treating acute myeloid leukemia.
Detailed description
Purpose:
Phase I: Determine the optimal dose and schedule of GO and zosuquidar when used in combination.
Phase II: Determine the complete remission rate (CR+CRp)
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 (2 listed)
- Morphologic evidence of acute myeloid leukemia in first relapse.
- Phase I: 18 years or older, Phase II: 50 years or older
Key exclusion criteria (3 listed)
- Prior treatment with zosuquidar
- Any investigational agent within 1 month of enrollment and lack of recovery from toxicities secondary to those agents
- History of stem cell transplant
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 |
|---|---|---|
| Zosuquidar | Drug | – |
| gemtuzumab ozogamicin | Drug | – |
Primary outcome
Not reported in the source record.
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 1 Apr 2008.
- Derived from this study: PubMed 37603048Marcelletti JF, Sikic BI. A clinical trial of zosuquidar plus gemtuzumab ozogamicin (GO) in relapsed or refractory acute myeloid leukemia (RR AML): evidence of efficacy based on leukemic blast P-glycoprotein functional phenotype. Cancer Chemother Pharmacol. 2023 Nov;92(5):369-380. doi: 10.1007/s00280-023-04578-9. Epub 2023 Aug 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zosuquidar and gemtuzumab ozogamicin in people with Leukemia, Myeloid, run by Kanisa Pharmaceuticals.
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 2 inclusion and 3 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 1 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00233909, which also lists 1 linked publication.
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 1 Apr 2008.