Chronic Myeloid LeukemiaPhase 1NCT00352677
Safety and Tolerability Study of INNO-406 to Treat Chronic Myeloid Leukemia or Acute Lymphocytic Leukemia
A Phase 1 study testing INNO-406 in people with Chronic Myeloid Leukemia and Acute Lymphocytic Leukemia, run by CytRx at 6 sites in 3 countries.
Trial summary
The purpose of this study is to determine the safety and effectiveness of INNO-406 in adult patients with imatinib-resistant or intolerant Philadelphia chromosome-positive (Ph+) leukemias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Acute Lymphocytic Leukemia
- What is being tested?
- INNO-406
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Jul 2006to May 2008
- 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
- Have a confirmed diagnosis of Ph+ ALL or CML in chronic, accelerated, or blastic phases that are either resistant to or intolerant of imatinib therapy.
- Be ≥18 years old.
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
- Have an estimated life expectancy of ≥12 weeks.
- Be male or non-pregnant, non-lactating female. Patients who are fertile must agree to use an effective barrier method of contraception while on therapy and for 90 days following discontinuation of study drug.
- Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug (if patient is a female of childbearing potential).
- Have acceptable pre-treatment clinical laboratory results.
Who cannot join
- Have received chemotherapy ≤1 week from the start of therapy, with the exception of hydroxyurea and corticosteroids.
- Have received imatinib ≤3 days prior to enrollment or have not recovered from side effects of imatinib therapy.
- Have impaired cardiac function.
- Have an active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment.
- Have clinically significant acute or chronic liver or renal disease considered unrelated to tumor.
- Have impaired gastrointestinal function that may significantly alter drug absorption (e.g., uncontrolled vomiting, ulcerative colitis, malabsorption, or small bowel resection).
Show all 11Show fewer
- Are pregnant or lactating.
- Have psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
- Have not recovered from acute toxicity of all previous therapy prior to enrollment.
- Have any other severe concurrent disease and/or uncontrolled medical conditions, which, in the judgment of the investigator, could predispose patients to unacceptable safety risks or compromise compliance with the protocol.
- Have a history of another primary malignancy that is currently clinically significant or requires active intervention.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Germany3 sites
Charite University of Medicine
Berlin, 13353
Johann Wolfgang Goethe Universität
Frankfurt am Main, 60590
University of Heidelberg Medical Clinic
Mannheim, 68305
United States2 sites
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of INNO-406 in Adult Patients With Imatinib-Resistant or Intolerant Philadelphia Chromosome-Positive (Ph+) Leukemias
The purpose of this study is to determine the safety and effectiveness of INNO-406 in adult patients with imatinib-resistant or intolerant Philadelphia chromosome-positive (Ph+) leukemias.
Read the detailed description
The purpose of this study is to determine the safety, tolerability and pharmacokinetic profile of INNO-406 when administered as a daily oral agent in adult patients with imatinib-resistant or intolerant Philadelphia chromosome-positive (Ph+) leukemias.
- Being tested
- INNO-406
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INNO-406Drug
Oral, twice daily self-administration of 10 mg and/or 50 mg tablets
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of INNO-406 when administered as a single agent to adult patients with imatinib-resistant or intolerant Ph+ leukemias.
Measured: One year
To determine the safety profile (including acute and chronic toxicities) and tolerability of INNO-406 in this patient population.
Measured: One year
Secondary outcomes (3)
To determine the pharmacokinetic (PK) profile of INNO-406.
Measured: One year
To assess BCR-ABL transcript levels and to analyze BCR-ABL mutations.
Measured: One year
To assess leukemia response rates in this patient population.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CytRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hagop Kantarjian, M.D., Principal investigator, University of Texas, MD Anderson Cancer Center, Houston, TX 713-792-7026 hkantarj@mdanderson.org
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352677
- Sponsor's protocol ID
- INNO-406
- Status last verified
- May 2009
- First submitted
- 14 Jul 2006
- Last updated
- 1 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of INNO-406 in Adult Patients With Imatinib-Resistant or Intolerant Philadelphia Chromosome-Positive (Ph+) Leukemias
- ClinicalTrials.gov ID
- NCT00352677
- Acronym / sponsor ID
- INNO-406
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CytRxIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 17 Jul 2006 (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 safety and effectiveness of INNO-406 in adult patients with imatinib-resistant or intolerant Philadelphia chromosome-positive (Ph+) leukemias.
Detailed description
The purpose of this study is to determine the safety, tolerability and pharmacokinetic profile of INNO-406 when administered as a daily oral agent in adult patients with imatinib-resistant or intolerant Philadelphia chromosome-positive (Ph+) leukemias.
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 (7 listed)
- Have a confirmed diagnosis of Ph+ ALL or CML in chronic, accelerated, or blastic phases that are either resistant to or intolerant of imatinib therapy.
- Be ≥18 years old.
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
- Have an estimated life expectancy of ≥12 weeks.
- Be male or non-pregnant, non-lactating female. Patients who are fertile must agree to use an effective barrier method of contraception while on therapy and for 90 days following discontinuation of study drug.
Key exclusion criteria (11 listed)
- Have received chemotherapy ≤1 week from the start of therapy, with the exception of hydroxyurea and corticosteroids.
- Have received imatinib ≤3 days prior to enrollment or have not recovered from side effects of imatinib therapy.
- Have impaired cardiac function.
- Have an active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment.
- Have clinically significant acute or chronic liver or renal disease considered unrelated to tumor.
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 |
|---|---|---|
| INNO-406Oral, twice daily self-administration of 10 mg and/or 50 mg tablets | Drug | – |
Primary outcome
To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of INNO-406 when administered as a single agent to adult patients with imatinib-resistant or intolerant Ph+ leukemias.
Time frame: One year
To determine the safety profile (including acute and chronic toxicities) and tolerability of INNO-406 in this patient population.
Time frame: One year
3 secondary outcomes
To determine the pharmacokinetic (PK) profile of INNO-406.
Time frame: One year
To assess BCR-ABL transcript levels and to analyze BCR-ABL mutations.
Time frame: One year
To assess leukemia response rates in this patient population.
Time frame: One year
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 Jun 2009.
Related trials for Chronic Myeloid Leukemia
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
Not yet recruitingPhase 2
Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia
Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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.
Hagop Kantarjian, M.D. principal investigator
University of Texas, MD Anderson Cancer Center, Houston, TX 713-792-7026 hkantarj@mdanderson.org
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INNO-406 in people with Chronic Myeloid Leukemia and Acute Lymphocytic Leukemia, run by CytRx at 6 sites in 3 countries.
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 7 inclusion and 11 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 Jun 2009. 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 Germany, United States, Israel. 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?
To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of INNO-406 when administered as a single agent to adult patients with imatinib-resistant or intolerant Ph+ leukemias. (time frame: One year). The study lists 2 primary outcomes in all. 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 1 Jun 2009.