Breast CancerPhase 2CONTESSA TRIONCT03952325
Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Triple-Negative MBC and Tesetaxel Monotherapy in Patients With HER2-Negative MBC
A Phase 2 study testing Tesetaxel, Nivolumab and Pembrolizumab in people with Breast Cancer, run by Odonate Therapeutics, Inc. at 12 sites in 3 countries.
Trial summary
CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). In Cohort 1, approximately 200 patients with triple-negative MBC who have not received prior chemotherapy for advanced disease will be randomized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tesetaxel, Nivolumab and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 9 Jul 2019to 23 Jun 2021
- Phase
- Phase 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
- Female or male patients aged:
- Cohort 1: ≥ 18 years old
- Cohort 2: ≥ 65 years old
- Cohort 3: ≥ 18 to < 65 years old
- Histologically or cytologically confirmed breast cancer
- Most recent biopsy must be HER2-negative
Show all 16Show fewer
- Cohort 1 only: Most recent biopsy must be hormone receptor (HR) (estrogen receptor and progesterone receptor) negative
- Measurable disease per RECIST 1.1.
- Patients with bone-only metastatic cancer must have a measurable lytic or mixed lytic-blastic lesion
- Known metastases to the CNS are permitted but not required
- Documented (including de novo): (a) locally advanced breast cancer that is not considered curable by surgery and/or radiation; or (b) metastatic breast cancer
- Disease-free interval of at least 12 months after the completion of systemic neoadjuvant or adjuvant chemotherapy for patients previously treated with systemic chemotherapy for a tumor surgically resected with curative intent
- Cohorts 2 and 3 only: Prior endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor unless endocrine therapy is not indicated. Any prior targeted therapies are permitted. There is no limit to the number of prior endocrine therapies.
- Cohort 1 only: At Screening, patients must have documented evidence of positive PD-L1 expression as assessed via immunohistochemistry (IHC) scoring by local, regional, or central laboratory testing
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Adequate bone marrow, hepatic and renal function
Who cannot join
- Prior chemotherapy for locally advanced or metastatic disease
- Cohort 1 only: prior treatment with pembrolizumab, nivolumab, atezolizumab, any other PD-(L)1/PD-L2 inhibitor or a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor
- Current evidence or history of leptomeningeal disease
- Known human immunodeficiency virus infection, unless well controlled
- Known active hepatitis B or known active hepatitis C infection
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with Study participation or investigational product administration or may interfere with the interpretation of Study results
Show all 20Show fewer
- Presence of neuropathy Grade > 1
- History of hypersensitivity to any of the Study drugs or any of their ingredients, as applicable
- Cohort 1 only:
- Chronic autoimmune disease
- Evidence of active, non-infectious pneumonia (eg, pneumonia due to autoimmune or connective tissue disease)
- Treatment with a live vaccine within 30 days prior to the first dose of nivolumab, pembrolizumab or atezolizumab
- History of active tuberculosis
- Prior organ transplantation including allogeneic stem cell transplantation
- Active infection requiring systemic therapy
- Current or prior use of immunosuppressive medication within 7 days prior to Cycle 1, Day 1
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
- Anticancer treatment, including endocrine therapy, radiotherapy (except stereotactic brain radiosurgery), chemotherapy or biologic therapy, ≤ 14 days prior to Enrollment
- Major surgery ≤ 28 days prior to Enrollment
- Less than 2 weeks or 5 plasma half-lives (whichever is greater) since last use of a medication or ingestion of an agent, beverage or food that is a known clinically relevant strong inhibitor or known clinically relevant inducer of the cytochrome P450 (CYP) 3A pathway
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States9 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
New York Cancer and Blood Specialists
East Setauket, New York, 11733
Sarah Cannon Research Institute - Florida Cancer Specialists
Fort Myers, Florida, 33901
West Cancer Center
Germantown, Tennessee, 38138
Virginia Oncology Associates
Norfolk, Virginia, 23502
Florida Cancer Specialists and Research Institute
St. Petersburg, Florida, 33705
Florida Cancer Specialists and Research Institute - Panhandle Region
Tallahassee, Florida, 32308
Florida Cancer Specialists and Research Institute
West Palm Beach, Florida, 33401
Singapore2 sites
John Hopkins Singapore International Medical Centre
Singapore
National Cancer Centre Singapore
Singapore
About this study
Official title: A Multicenter, Phase 2 Study of Tesetaxel Plus Three Different PD-(L)1 Inhibitors in Patients With Triple-Negative, Locally Advanced or Metastatic Breast Cancer and Tesetaxel Monotherapy in Elderly and Non-Elderly Adult Patients With HER2-Negative, Locally Advanced or Metastatic Breast Cancer
CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). In Cohort 1, approximately 200 patients with triple-negative MBC who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel plus either: (1) nivolumab; (2) pembrolizumab; or (3) atezolizumab. The primary efficacy endpoints for Cohort 1 are objective response rate (ORR) and progression free survival (PFS) in patients with programmed death-ligand 1 (PD-L1) positive status. In Cohort 2, approximately 60 elderly patients with human epidermal growth factor receptor 2 (HER2) negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy. The primary efficacy endpoints for Cohort 2 are ORR and PFS in patients with hormone receptor (HR)-positive, HER2-negative disease. In Cohort 3, approximately 60 non-elderly adult patients with HER2-negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy. The primary efficacy endpoints for Cohort 3 are ORR and PFS in patients with HR positive, HER2-negative disease.
Read the detailed description
CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with MBC.
Cohort 1:
Approximately 200 patients with triple-negative MBC who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel dosed orally at 27 mg/m2 once every three weeks (Q3W) plus either:
- Nivolumab at 360 mg by intravenous infusion Q3W;
- Pembrolizumab at 200 mg by intravenous infusion Q3W; or
- Atezolizumab at 1,200 mg by intravenous infusion Q3W.
Nivolumab and pembrolizumab (programmed cell death protein 1 [PD-1] inhibitors) and atezolizumab (a programmed death-ligand 1 [PD-L1] inhibitor) are immuno-oncology (IO) agents approved for the treatment of multiple types of cancer. Two of these agents, atezolizumab and pembrolizumab, have been approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with triple-negative MBC. The primary efficacy endpoints for Cohort 1 are ORR and PFS in patients with PD-L1 positive status. The secondary efficacy endpoints are ORR and PFS in all patients, duration of response (DoR) and overall survival (OS).
Cohort 2:
Approximately 60 elderly patients with HER2-negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy dosed orally at 27 mg/m2 Q3W. The primary efficacy endpoints for Cohort 2 are ORR and PFS in patients with HR-positive, HER2-negative disease. The secondary efficacy endpoints are ORR and PFS in patients with triple-negative disease, DoR and OS.
Cohort 3:
Approximately 60 non-elderly adult patients with HER2-negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy dosed orally at 27 mg/m2 Q3W. The primary efficacy endpoints for Cohort 3 are ORR and PFS in patients with HR positive, HER2-negative disease. The secondary efficacy endpoints are ORR and PFS in patients with triple negative disease, DoR and OS.
- Conditions
- Breast Cancer
- Being tested
- Tesetaxel, Nivolumab, Pembrolizumab, Atezolizumab
- Keywords
- Tesetaxel, PD-(L)1 inhibitor, Triple-negative breast cancer, Locally advanced or metastatic breast cancer, Taxane, Metastatic breast cancer, Breast cancer, Combination of tesetaxel and PD-(L)1 inhibitors, HER2 negative, Oral chemotherapy, Central nervous system (CNS) metastases
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TesetaxelDrug
Tesetaxel at 27 mg/m2 orally Q3W
TesetaxelDrug
Tesetaxel at 27 mg/m2 orally Q3W
TesetaxelDrug
Tesetaxel at 27 mg/m2 orally Q3W
NivolumabDrug
Nivolumab at 360 mg by intravenous infusion Q3W
PembrolizumabDrug
Pembrolizumab at 200 mg by intravenous infusion Q3W
AtezolizumabDrug
Atezolizumab at 1,200 mg by intravenous infusion Q3W
TesetaxelDrug
Tesetaxel at 27 mg/m2 orally Q3W
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, Arm A: Tesetaxel plus nivolumab | Experimental | Not described Receives: Drug: Tesetaxel; Drug: Nivolumab |
| Cohort 1, Arm B: Tesetaxel plus pembrolizumab | Experimental | Not described Receives: Drug: Tesetaxel; Drug: Pembrolizumab |
| Cohort 1, Arm C: Tesetaxel plus atezolizumab | Experimental | Not described Receives: Drug: Tesetaxel; Drug: Atezolizumab |
| Cohort 2: Tesetaxel | Experimental | Not described Receives: Drug: Tesetaxel |
| Cohort 3: Tesetaxel | Experimental | Not described Receives: Drug: Tesetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: ORR in patients with PD-L1 positive status
Measured: Approximately 2.0-3.0 years
Cohort 1: PFS in patients with PD-L1 positive status
Measured: Approximately 2.5-3.5 years
Cohort 2: ORR in patients with HR-positive, HER2-negative disease
Measured: Approximately 2.0-3.0 years
Cohort 2: PFS in patients with HR-positive, HER2-negative disease
Measured: Approximately 2.0-3.0 years
Cohort 3: ORR in patients with HR-positive, HER2-negative disease
Measured: Approximately 2.0-3.0 years
Cohort 3: PFS in patients with HR-positive, HER2-negative disease
Measured: Approximately 2.0-3.0 years
Secondary outcomes (12)
Cohort 1: ORR in all patients
Measured: Approximately 2.0-3.0 years
Cohort 1: PFS in all patients
Measured: Approximately 2.0-3.0 years
Cohort 1: DoR
Measured: Approximately 2.5-3.5 years
Cohort 1: OS
Measured: Approximately 4.0-5.0 years
Cohort 2: ORR in patients with triple-negative disease
Measured: Approximately 2.0-3.0 years
Cohort 2: PFS in patients with triple-negative disease
Measured: Approximately 2.5-3.5 years
Cohort 2: DoR
Measured: Approximately 2.5-3.5 years
Cohort 2: OS
Measured: Approximately 4.0-5.0 years
Cohort 3: ORR in patients with triple-negative disease
Measured: Approximately 1.0-2.0 years
Cohort 3: PFS in patients with triple-negative disease
Measured: Approximately 1.5-2.5 years
Cohort 3: DoR
Measured: Approximately 2.5-3.5 years
Cohort 3: OS
Measured: Approximately 4.0-5.0 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start9 Jul 2019
- Primary completion23 Jun 2021
- Study completion23 Jun 2021
Why it stopped: The Sponsor has discontinued the development of tesetaxel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odonate Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph O'Connell, M.D., Study director, Odonate Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952325
- Sponsor's protocol ID
- ODO-TE-B202
- Acronym
- CONTESSA TRIO
- Status last verified
- Jul 2021
- First submitted
- 14 May 2019
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase 2 Study of Tesetaxel Plus Three Different PD-(L)1 Inhibitors in Patients With Triple-Negative, Locally Advanced or Metastatic Breast Cancer and Tesetaxel Monotherapy in Elderly and Non-Elderly Adult Patients With HER2-Negative, Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03952325
- Acronym / sponsor ID
- CONTESSA TRIO / ODO-TE-B202
- Conditions
- Breast Cancer
- Keywords
- Tesetaxel, PD-(L)1 inhibitor, Triple-negative breast cancer, Locally advanced or metastatic breast cancer, Taxane, Metastatic breast cancer, Breast cancer, Combination of tesetaxel and PD-(L)1 inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponsor has discontinued the development of tesetaxel
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Odonate Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 16 May 2019 (actual)
- 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.
CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). In Cohort 1, approximately 200 patients with triple-negative MBC who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel plus either: (1) nivolumab; (2) pembrolizumab; or (3) atezolizumab. The primary efficacy endpoints for Cohort 1 are objective response rate (ORR) and progression free survival (PFS) in patients with programmed death-ligand 1 (PD-L1) positive status. In Cohort 2, approximately 60 elderly patients with human epidermal growth factor receptor 2 (HER2) negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy. The primary efficacy endpoints for Cohort 2 are ORR and PFS in patients with hormone receptor (HR)-positive, HER2-negative disease. In Cohort 3, approximately 60 non-elderly adult patients with HER2-negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy. The primary efficacy endpoints for Cohort 3 are ORR and PFS in patients with HR positive, HER2-negative disease.
Detailed description
CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with MBC.
Cohort 1:
Approximately 200 patients with triple-negative MBC who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel dosed orally at 27 mg/m2 once every three weeks (Q3W) plus either:
- Nivolumab at 360 mg by intravenous infusion Q3W;
- Pembrolizumab at 200 mg by intravenous infusion Q3W; or
- Atezolizumab at 1,200 mg by intravenous infusion Q3W.
Nivolumab and pembrolizumab (programmed cell death protein 1 [PD-1] inhibitors) and atezolizumab (a programmed death-ligand 1 [PD-L1] inhibitor) are immuno-oncology (IO) agents approved for the treatment of multiple types of cancer. Two of these agents, atezolizumab and pembrolizumab, have been approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with triple-negative MBC. The primary efficacy endpoints for Cohort 1 are ORR and PFS in patients with PD-L1 positive status. The secondary efficacy endpoints are ORR and PFS in all patients, duration of response (DoR) and overall survival (OS).
Cohort 2:
Approximately 60 elderly patients with HER2-negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy dosed orally at 27 mg/m2 Q3W. The primary efficacy endpoints for Cohort 2 are ORR and PFS in patients with HR-positive, HER2-negative disease. The secondary efficacy endpoints are ORR and PFS in patients with triple-negative disease, DoR and OS.
Cohort 3:
Approximately 60 non-elderly adult patients with HER2-negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy dosed orally at 27 mg/m2 Q3W. The primary efficacy endpoints for Cohort 3 are ORR and PFS in patients with HR positive, HER2-negative disease. The secondary efficacy endpoints are ORR and PFS in patients with triple negative disease, DoR and OS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, Arm A: Tesetaxel plus nivolumab | Experimental | Drug: Tesetaxel, Drug: Nivolumab |
| Cohort 1, Arm B: Tesetaxel plus pembrolizumab | Experimental | Drug: Tesetaxel, Drug: Pembrolizumab |
| Cohort 1, Arm C: Tesetaxel plus atezolizumab | Experimental | Drug: Tesetaxel, Drug: Atezolizumab |
| Cohort 2: Tesetaxel | Experimental | Drug: Tesetaxel |
| Cohort 3: Tesetaxel | Experimental | Drug: Tesetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Female or male patients aged:
- Histologically or cytologically confirmed breast cancer
- Most recent biopsy must be HER2-negative
- Cohort 1 only: Most recent biopsy must be hormone receptor (HR) (estrogen receptor and progesterone receptor) negative
- Measurable disease per RECIST 1.1.
Key exclusion criteria (20 listed)
- Prior chemotherapy for locally advanced or metastatic disease
- Cohort 1 only: prior treatment with pembrolizumab, nivolumab, atezolizumab, any other PD-(L)1/PD-L2 inhibitor or a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor
- Current evidence or history of leptomeningeal disease
- Known human immunodeficiency virus infection, unless well controlled
- Known active hepatitis B or known active hepatitis C 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 |
|---|---|---|
| TesetaxelTesetaxel at 27 mg/m2 orally Q3W | Drug | Cohort 1, Arm A: Tesetaxel plus nivolumab |
| TesetaxelTesetaxel at 27 mg/m2 orally Q3W | Drug | Cohort 1, Arm B: Tesetaxel plus pembrolizumab |
| TesetaxelTesetaxel at 27 mg/m2 orally Q3W | Drug | Cohort 1, Arm C: Tesetaxel plus atezolizumab |
| NivolumabNivolumab at 360 mg by intravenous infusion Q3W | Drug | Cohort 1, Arm A: Tesetaxel plus nivolumab |
| PembrolizumabPembrolizumab at 200 mg by intravenous infusion Q3W | Drug | Cohort 1, Arm B: Tesetaxel plus pembrolizumab |
| AtezolizumabAtezolizumab at 1,200 mg by intravenous infusion Q3W | Drug | Cohort 1, Arm C: Tesetaxel plus atezolizumab |
| TesetaxelTesetaxel at 27 mg/m2 orally Q3W | Drug | Cohort 2: Tesetaxel, Cohort 3: Tesetaxel |
Primary outcome
Cohort 1: ORR in patients with PD-L1 positive status
Time frame: Approximately 2.0-3.0 years
Cohort 1: PFS in patients with PD-L1 positive status
Time frame: Approximately 2.5-3.5 years
Cohort 2: ORR in patients with HR-positive, HER2-negative disease
Time frame: Approximately 2.0-3.0 years
Cohort 2: PFS in patients with HR-positive, HER2-negative disease
Time frame: Approximately 2.0-3.0 years
Cohort 3: ORR in patients with HR-positive, HER2-negative disease
Time frame: Approximately 2.0-3.0 years
Cohort 3: PFS in patients with HR-positive, HER2-negative disease
Time frame: Approximately 2.0-3.0 years
12 secondary outcomes
Cohort 1: ORR in all patients
Time frame: Approximately 2.0-3.0 years
Cohort 1: PFS in all patients
Time frame: Approximately 2.0-3.0 years
Cohort 1: DoR
Time frame: Approximately 2.5-3.5 years
Cohort 1: OS
Time frame: Approximately 4.0-5.0 years
Cohort 2: ORR in patients with triple-negative disease
Time frame: Approximately 2.0-3.0 years
Cohort 2: PFS in patients with triple-negative disease
Time frame: Approximately 2.5-3.5 years
Cohort 2: DoR
Time frame: Approximately 2.5-3.5 years
Cohort 2: OS
Time frame: Approximately 4.0-5.0 years
Cohort 3: ORR in patients with triple-negative disease
Time frame: Approximately 1.0-2.0 years
Cohort 3: PFS in patients with triple-negative disease
Time frame: Approximately 1.5-2.5 years
Cohort 3: DoR
Time frame: Approximately 2.5-3.5 years
Cohort 3: OS
Time frame: Approximately 4.0-5.0 years
Results and safety
The study was stopped early (reason given: The Sponsor has discontinued the development of tesetaxel). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
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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.
Joseph O'Connell, M.D. study director
Odonate Therapeutics, Inc.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tesetaxel, Nivolumab and Pembrolizumab in people with Breast Cancer, run by Odonate Therapeutics, Inc. at 12 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 16 inclusion and 20 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 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Singapore, South Korea. 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 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 was stopped early (reason given: The Sponsor has discontinued the development of tesetaxel). 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?
Cohort 1: ORR in patients with PD-L1 positive status (time frame: Approximately 2.0-3.0 years). The study lists 6 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 30 Jul 2021.