Advanced Solid TumorsPhase 1NCT00831896
Phase I Study of TAK-701 in Adult Patients With Advanced Nonhematological Malignancies
A Phase 1 study testing TAK-701 in people with Advanced Solid Tumors, run by Millennium Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
This study is a multicenter, open-label, dose escalation, phase 1 study of TAK 701 in adult patients with advanced nonhematologic malignancies. This study will be the first to administer TAK 701 to humans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- TAK-701
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2009to May 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
- Male or female patients aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Diagnosis of a nonhematologic malignancy for which standard curative or lifeprolonging treatment does not exist or is no longer effective.
- Radiographically or clinically evaluable tumor; however, measurable disease is not required for participation in this study (eg, patients with pleural effusion or ascites).
- Female patients who:
- Are postmenopausal for at least 1 year before the screening visit, or
Show all 12Show fewer
- Are surgically sterile, or
- If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 3 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse.
- Male patients, even if surgically sterilized (ie, status postvasectomy), who:
- Agree to practice effective barrier contraception during the entire study drug treatment period and through 3 months after the last dose of TAK-701, or
- Agree to completely abstain from heterosexual intercourse.
- Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
Who cannot join
- Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- Major surgery within 14 days before the first dose of TAK-701 or any planned/anticipated surgery during the study period.
- Positive test for Hepatitis B or C infection.
- Active alcohol abuse
- Active infection requiring systemic therapy, or other serious infection.
- Antineoplastic therapy (including unconjugated therapeutic antibodies and toxin immunoconjugates) or any experimental therapy within 21 days before the first dose of TAK-701.
Show all 21Show fewer
- Radiotherapy within 21 days before the first dose of TAK-701.
- Nitrosoureas or mitomycin-C within 6 weeks before the first dose of TAK-701.
- Autologous stem cell transplant within 3 months before the first dose of TAK-701, or prior allogeneic stem cell transplant at any time.
- Any prior exposure to anti-HGF therapy (eg, AMG-102, AV-299).
- The patient has symptomatic brain metastasis.
- Absolute neutrophil count < 1,500/mm3; platelet count < 100,000/mm3.
- Calculated creatinine clearance < 50mL/minute
- Any of the following clinical laboratory results during screening (ie, within 28 days before the first dose of TAK-701):
- Bilirubin > 1.5 times the upper limit of the normal range (ULN).
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times the ULN. AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of metastatic disease to liver and/or to bone.
- Known human immunodeficiency virus (HIV) positive.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Uncontrolled cardiovascular condition, including ongoing cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months.
- Patients having QTc > 470 msec on a 12-lead ECG obtained within 28 days before first study drug administration.
- Presence of serious or nonhealing wound, ulcer or bone fracture.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University School of Medicine, Winship Cancer Institute
Atlanta, Georgia, 30322
The Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: A Multicenter, Open-Label, Dose Escalation Phase I Study of TAK-701 in Adult Patients With Advanced Nonhematologic Malignancies
This study is a multicenter, open-label, dose escalation, phase 1 study of TAK 701 in adult patients with advanced nonhematologic malignancies. This study will be the first to administer TAK 701 to humans. The primary purpose of this study is to determine the safety profile, tolerability, and pharmacokinetics profile of TAK-701.
- Conditions
- Advanced Solid Tumors
- Being tested
- TAK-701
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-701Biological
Either 2, 5, 10, or 20 mg/kg IV. Cycle 1: single dose at 2x the dose assignment; Cycle 2 and beyond: dose once every two weeks
Dosing continues until disease progression, unacceptable toxicity related to TAK-701, or maximum of 12 cycles, unless determined that patient would benefit from continued therapy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | TAK-701 Receives: Biological: TAK-701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile (adverse events including dose limiting toxicities, clinical safety assessments such as human antihumanized antibody (HAHA) and neutr. HAHA), tolerability (maximum tolerated dose or maximum feasible dose), and pharmacokinetic profile.
Measured: Duration of study
Secondary outcomes (2)
Pharmacodynamic profile, cardiac repolarization effects, antitumor activity, and recommended Phase 2 dose of TAK-701
Measured: Duration of study
Investigator's assessment of disease response using Response Evaluation Criteria in Solid Tumors guidelines and relevant tumor markers in serum such as PSA, CA 125 and CA 19-9
Measured: Duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionNov 2010
- Study completionMay 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
- 27 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
- NCT00831896
- Sponsor's protocol ID
- C17001
- Status last verified
- Dec 2011
- First submitted
- 26 Jan 2009
- Last updated
- 2 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Dose Escalation Phase I Study of TAK-701 in Adult Patients With Advanced Nonhematologic Malignancies
- ClinicalTrials.gov ID
- NCT00831896
- Acronym / sponsor ID
- C17001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 29 Jan 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 a multicenter, open-label, dose escalation, phase 1 study of TAK 701 in adult patients with advanced nonhematologic malignancies. This study will be the first to administer TAK 701 to humans. The primary purpose of this study is to determine the safety profile, tolerability, and pharmacokinetics profile of TAK-701.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: TAK-701TAK-701 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female patients aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Diagnosis of a nonhematologic malignancy for which standard curative or lifeprolonging treatment does not exist or is no longer effective.
- Radiographically or clinically evaluable tumor; however, measurable disease is not required for participation in this study (eg, patients with pleural effusion or ascites).
- Female patients who:
Key exclusion criteria (21 listed)
- Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- Major surgery within 14 days before the first dose of TAK-701 or any planned/anticipated surgery during the study period.
- Positive test for Hepatitis B or C infection.
- Active alcohol abuse
- Active infection requiring systemic therapy, or other serious infection.
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-701Either 2, 5, 10, or 20 mg/kg IV. Cycle 1: single dose at 2x the dose assignment; Cycle 2 and beyond: dose once every two weeks Dosing continues until disease progression, unacceptable toxicity related to TAK-701, or maximum of 12 cycles, unless determined that patient would benefit from continued therapy. | Biological | 1 |
Primary outcome
Safety profile (adverse events including dose limiting toxicities, clinical safety assessments such as human antihumanized antibody (HAHA) and neutr. HAHA), tolerability (maximum tolerated dose or maximum feasible dose), and pharmacokinetic profile.
Time frame: Duration of study
2 secondary outcomes
Pharmacodynamic profile, cardiac repolarization effects, antitumor activity, and recommended Phase 2 dose of TAK-701
Time frame: Duration of study
Investigator's assessment of disease response using Response Evaluation Criteria in Solid Tumors guidelines and relevant tumor markers in serum such as PSA, CA 125 and CA 19-9
Time frame: Duration of study
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 2 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-701 in people with Advanced Solid Tumors, 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 12 inclusion and 21 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 2 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?
Safety profile (adverse events including dose limiting toxicities, clinical safety assessments such as human antihumanized antibody (HAHA) and neutr. HAHA), tolerability (maximum tolerated dose or maximum feasible dose), and pharmacokinetic profile. (time frame: Duration of study). 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 2 Dec 2011.