Advanced Solid TumorsPhase 1NCT01529307
First in Human Trial of TAS266 in Patients With Advanced Solid Tumors
A Phase 1 study testing TAS266 in people with Advanced Solid Tumors, run by Novartis Pharmaceuticals at 3 sites in United States.
Trial summary
This study will assess safety, tolerability, maximum tolerated dose or recommended dose for expansion of TAS266 administered by IV infusion to patients with advanced solid tumors. 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?
- TAS266
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2012to Sep 2012
- 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
- Confirmed diagnosis of solid tumors
- 18 years or older
- ECOG performance status of 0, 1 or 2
- Adequate bone marrow, hepatic and renal function
- Obtained written informed consent
Who cannot join
- Patients with primary CNS tumor or CNS tumor involvement. However patients with CNS metastases may be allowed if certain conditions are met.
- Major surgery within 4 weeks before study treatment
- Prior anaphylactic or other severe infusion reactions to human immunoglobulin or antibody formulations
- Impaired cardiac functions
- Previous hepatitis viral infection such as hepatitis B or hepatitis C
- Diagnosis of HIV infection
- Pregnant or nursing (lactating) women
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Utah / Huntsman Cancer Institute Huntsman UT
Salt Lake City, Utah, 84103
South Texas Accelerated Research Therapeutics START
San Antonio, Texas, 789229
H. Lee Moffitt Cancer Center/University of South Florida Moffitt SC
Tampa, Florida, 33612
About this study
Official title: A Phase I, Open-label Dose Escalation Study With Safety Expansion of TAS266 Administered by IV Infusion to Patients With Advanced Solid Tumors
This study will assess safety, tolerability, maximum tolerated dose or recommended dose for expansion of TAS266 administered by IV infusion to patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- TAS266
- Keywords
- Biologic,, solid tumors,, Death Receptor 5 agonist,, caspase-8
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS266Drug
TAS266 IV infusions given weekly
| Study group | Role | What they receive |
|---|---|---|
| TAS266 | Experimental | Not described Receives: Drug: TAS266 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and characteristics of Dose limiting toxicities at each dose level
Measured: 2 years
Secondary outcomes (4)
Type, frequency, and severity of AEs, changes in laboratory and clinical assessments
Measured: 2 years
TAS266 serum concentrations and PK parameters: Cmax, Tmax, AUC0-tlast, Tlast, T1/2 and accumulation ratio of TAS266
1 Treatment Cycle = 28 days,) assuming maximum 6 cycles of treatment
Measured: 8 timepoints each for Cycles 1 and 2, prior to dosing on Day 1 of Cycles 3, 4, 5 and 6, at End of Treatment
Presence and concentration of anti-TAS266 antibodies
Measured: 2 Years
Tumor response
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2012
- Study completionSep 2012
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.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529307
- Sponsor's protocol ID
- CTAS266X2101
- Status last verified
- Dec 2012
- First submitted
- 1 Feb 2012
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label Dose Escalation Study With Safety Expansion of TAS266 Administered by IV Infusion to Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01529307
- Acronym / sponsor ID
- CTAS266X2101
- Conditions
- Advanced Solid Tumors
- Keywords
- Biologic,, solid tumors,, Death Receptor 5 agonist,, caspase-8
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 8 Feb 2012 (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 will assess safety, tolerability, maximum tolerated dose or recommended dose for expansion of TAS266 administered by IV infusion to patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAS266 | Experimental | Drug: TAS266 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of solid tumors
- 18 years or older
- ECOG performance status of 0, 1 or 2
- Adequate bone marrow, hepatic and renal function
- Obtained written informed consent
Key exclusion criteria (8 listed)
- Patients with primary CNS tumor or CNS tumor involvement. However patients with CNS metastases may be allowed if certain conditions are met.
- Major surgery within 4 weeks before study treatment
- Prior anaphylactic or other severe infusion reactions to human immunoglobulin or antibody formulations
- Impaired cardiac functions
- Previous hepatitis viral infection such as hepatitis B or hepatitis C
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 |
|---|---|---|
| TAS266TAS266 IV infusions given weekly | Drug | TAS266 |
Primary outcome
Frequency and characteristics of Dose limiting toxicities at each dose level
Time frame: 2 years
4 secondary outcomes
Type, frequency, and severity of AEs, changes in laboratory and clinical assessments
Time frame: 2 years
TAS266 serum concentrations and PK parameters: Cmax, Tmax, AUC0-tlast, Tlast, T1/2 and accumulation ratio of TAS266
Time frame: 8 timepoints each for Cycles 1 and 2, prior to dosing on Day 1 of Cycles 3, 4, 5 and 6, at End of Treatment
Presence and concentration of anti-TAS266 antibodies
Time frame: 2 Years
Tumor response
Time frame: 2 Years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Results for CTAS266X2101 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 TAS266 in people with Advanced Solid Tumors, run by Novartis Pharmaceuticals 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 21 Dec 2020. 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 was stopped early. Results are not available in the source record.
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?
Frequency and characteristics of Dose limiting toxicities at each dose level (time frame: 2 years). 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 21 Dec 2020.