Advanced Solid TumorsPhase 1NCT00935844
Study of TAK-901 in Adults With Advanced Solid Tumors or Lymphoma
A Phase 1 study testing TAK-901 in people with Advanced Solid Tumors and Lymphoma, run by Millennium Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
This study is being conducted to evaluate the safety profile and the Maximum Tolerated Dose (MTD) of TAK-901 in adult patients with advanced solid tumors or lymphoma. This study will help to identify the recommended phase 2 dose and infusion duration, and describe the pharmacokinetics of TAK-901. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Lymphoma
- What is being tested?
- TAK-901
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2009to Nov 2011
- 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
- Each patient must meet all of the following criteria to be enrolled in the study:
- ECOG performance status of < or equal to 2.
- Diagnosis of solid tumor malignancy or lymphoma for which standard treatment is no longer effective.
- Have a radiographically or clinically evaluable tumor or lymphoma.
- Measurable disease as described in the protocol.
- Suitable venous access for the study-required blood sampling.
Show all 13Show fewer
- Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.
- Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse.
- Voluntary written consent.
- Weigh at least 45 kg.
- Recovered from the reversible effects of prior antineoplastic therapy.
- Meet clinical laboratory values during the screening period as specified in the protocol.
- Left ventricular ejection fraction (LVEF) > or equal to 50% by echocardiogram or multiple acquisition scan (MUGA).
Who cannot join
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Diagnosis of primary CNS malignancy or carcinomatous meningitis.
- Patient has symptomatic brain metastasis.
- Prior bone allogeneic bone marrow or stem cell transplant.
- Prior radiotherapy involving > or equal to 30% of the hematopoietically active bone marrow, within 21 days before the start of the study drug.
- Systemic antineoplastic therapy within 28 days before the start of the study drug, except for luteinizing hormone-releasing-hormone (LHRH) agonist therapy.
Show all 19Show fewer
- Exposure to nitrosureas or mitomycin C within 42 days before the start of the study drug.
- Treatment with monoclonal antibodies within 28 days before the start of the study drug.
- Known allergy or hypersensitivity to compounds of similar chemical composition to TAK-901 or its excipient, Captisol.
- Female patients who are lactating or who have a positive serum pregnancy test during the screening period or a positive serum pregnancy test during the screening period.
- Myocardial infarction within 6 months before enrollment.
- Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Abnormalities on 12-lead electrocardiogram (ECG) as specified in the protocol.
- Infection requiring systemic anti-infective therapy within 14 days before the start of study drug.
- Known human immunodeficiency virus (HIV)positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
- Diagnosed or treated for another malignancy within 2 years before the start of study drug or previously diagnosed with another malignancy and have any evidence of residual disease.
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment.
- Treatment with any investigational products within 28 days before the first dose of study drug.
- Systemic use of strong CYP3A inhibitors or inducers (as specified in the protocol) within 14 days before the first dose of study drug.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The University of Michigan
Ann Arbor, Michigan
Karmanos Cancer Center
Detroit, Michigan, 48201
Fox Chase Cancer Center
Rockledge, Pennsylvania, 19046
About this study
Official title: An Open-Label, Dose Escalation, Phase I Study of TAK-901 in Adult Patients With Advanced Solid Tumors or Lymphoma
This study is being conducted to evaluate the safety profile and the Maximum Tolerated Dose (MTD) of TAK-901 in adult patients with advanced solid tumors or lymphoma. This study will help to identify the recommended phase 2 dose and infusion duration, and describe the pharmacokinetics of TAK-901.
- Conditions
- Advanced Solid Tumors, Lymphoma
- Being tested
- TAK-901
- Keywords
- Advanced solid tumors, Lymphoma
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-901Drug
This study consists of three sequential parts.
Part 1: Escalating doses of TAK-901 will be administered via IV infusion over a 3-hour period on Days 1, 4, 8, 11, 15, and 18 of each 28-day cycle.
Part 2: Escalating doses of TAK-901 (starting at one-third of the dose identified as the MTD in Part 1) will be administered as a 1-hour infusion on Days 1, 4, 8, 11, 15, and 18 of each 28-day cycle.
Part 3: TAK-901 will be administered to approximately 20 patients using the dose identified as the MTD in the escalation phase. The infusion duration of TAK-901 will be determined after completion of Part 2.
| Study group | Role | What they receive |
|---|---|---|
| TAK-901 Arm | Experimental | Not described Receives: Drug: TAK-901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the MTD of TAK-901 administered as either a 3-hour or 1-hour infusion.
Measured: 12 months
To adaptively adjust the estimate of the MTD of TAK-901 from the escalation phase in an expansion cohort of subjects.
Measured: 12 months
Secondary outcomes (3)
To evaluate the pharmacokinetic profile of TAK-901 and its primary metabolite (M-I).
Measured: 12 months
To evaluate disease response.
Measured: 12 months
To investigate the effect of TAK-901 on tumor proliferation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionAug 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Millennium Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935844
- Sponsor's protocol ID
- C19001
- Status last verified
- Dec 2011
- First submitted
- 7 Jul 2009
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose Escalation, Phase I Study of TAK-901 in Adult Patients With Advanced Solid Tumors or Lymphoma
- ClinicalTrials.gov ID
- NCT00935844
- Acronym / sponsor ID
- C19001
- Conditions
- Advanced Solid Tumors, Lymphoma
- Keywords
- Advanced solid tumors, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 9 Jul 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.
This study is being conducted to evaluate the safety profile and the Maximum Tolerated Dose (MTD) of TAK-901 in adult patients with advanced solid tumors or lymphoma. This study will help to identify the recommended phase 2 dose and infusion duration, and describe the pharmacokinetics of TAK-901.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAK-901 Arm | Experimental | Drug: TAK-901 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- ECOG performance status of < or equal to 2.
- Diagnosis of solid tumor malignancy or lymphoma for which standard treatment is no longer effective.
- Have a radiographically or clinically evaluable tumor or lymphoma.
- Measurable disease as described in the protocol.
- Suitable venous access for the study-required blood sampling.
Key exclusion criteria (19 listed)
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Diagnosis of primary CNS malignancy or carcinomatous meningitis.
- Patient has symptomatic brain metastasis.
- Prior bone allogeneic bone marrow or stem cell transplant.
- Prior radiotherapy involving > or equal to 30% of the hematopoietically active bone marrow, within 21 days before the start of the study drug.
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 |
|---|---|---|
| TAK-901This study consists of three sequential parts. Part 1: Escalating doses of TAK-901 will be administered via IV infusion over a 3-hour period on Days 1, 4, 8, 11, 15, and 18 of each 28-day cycle. Part 2: Escalating doses of TAK-901 (starting at one-third of the dose identified as the MTD in Part 1) will be administered as a 1-hour infusion on Days 1, 4, 8, 11, 15, and 18 of each 28-day cycle. Part 3: TAK-901 will be administered to approximately 20 patients using the dose identified as the MTD in the escalation phase. The infusion duration of TAK-901 will be determined after completion of Part 2. | Drug | TAK-901 Arm |
Primary outcome
To identify the MTD of TAK-901 administered as either a 3-hour or 1-hour infusion.
Time frame: 12 months
To adaptively adjust the estimate of the MTD of TAK-901 from the escalation phase in an expansion cohort of subjects.
Time frame: 12 months
3 secondary outcomes
To evaluate the pharmacokinetic profile of TAK-901 and its primary metabolite (M-I).
Time frame: 12 months
To evaluate disease response.
Time frame: 12 months
To investigate the effect of TAK-901 on tumor proliferation.
Time frame: 12 months
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 8 Dec 2011.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
Medical Monitor study director
Millennium Pharmaceuticals, Inc.
3 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 TAK-901 in people with Advanced Solid Tumors and Lymphoma, run by Millennium Pharmaceuticals, Inc. at 3 sites 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 13 inclusion and 19 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 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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 identify the MTD of TAK-901 administered as either a 3-hour or 1-hour infusion. (time frame: 12 months). 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 8 Dec 2011.