Advanced Solid MalignanciesPhase 1PT01NCT04136834
A Phase I Open-label Study for Subjects With Advanced Malignancies
A Phase 1 study testing PT01 (Pegtomarginase) in people with Advanced Solid Malignancies, run by Athenex, Inc. at 3 sites in United States.
Trial summary
This is a first-in-human (FIH) Phase 1 dose escalation study to evaluate the safety, tolerability, PK, PD, and preliminary activity of PT01 administered IV in subjects with advanced malignancies.' Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Malignancies
- What is being tested?
- PT01 (Pegtomarginase)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Apr 2021to 1 Dec 2022
- 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
- Eligible subjects must have/be:
- Able to understand and voluntarily sign an informed consent form (ICF)
- Male and female adults ≥18 years of age at the time of informed consent
- Advanced solid malignancies for which no standard therapy is available. Subjects in whom available standard therapy is contraindicated may be eligible.
- For Dose Expansion Phase:
- Expansion Group A: Histologically confirmed unresectable locally advanced or metastatic (AJCC stage IIIB, IIIC, or IV) cutaneous malignant melanoma for which no standard therapy is suitable.
Show all 26Show fewer
- At least 1 measurable site of disease as defined per RECIST v1.1 criteria (Dose Expansion Phase) or evaluable disease (Dose Escalation Phase only)
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
- Life expectancy of >12 weeks
- Adequate hematologic status within 28 days prior to dosing as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain:
- Absolute neutrophil count (ANC) ≥1.5 × 109/L
- Platelet count ≥100 × 109/L
- Hemoglobin ≥90 g/L
- Adequate liver function as demonstrated by:
- Serum bilirubin <2 × the upper limit of normal (ULN)
- Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤3 × ULN or ≤5 × ULN in subjects with liver metastases
- Gamma-glutamyl transferase ≤5 × ULN Athenex, Inc. Confidential Page 9 Final v2.0_17 Jun 2019 Clinical Study Protocol_Amendment 01 ATX-PT01-001
- Alkaline phosphatase ≤3 × ULN or ≤5 × ULN if bone or liver metastasis is present
- Serum creatinine ≤1.5 × ULN or estimated creatinine clearance ≥50 mL/min according to the Cockcroft-Gault formula
- Prothrombin time(PT) (or International Normalized Ratio[INR]) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN or within the intended therapeutic range within 72 hours before the first dose of study drug in subjects receiving anticoagulant therapy
- Willing and able to comply with scheduled visits, treatment plan, and laboratory tests
- Absence of any other malignancy which has been active or treated within the past 3 years, except for cervical intraepithelial neoplasia, and nonmelanoma skin cancers (basal cell and squamous cell carcinomas)
- Men who are sterile (including vasectomy confirmed by post vasectomy semen analysis) OR agree to use a condom with spermicide and to not donate sperm during the study and for at least 90 days following last dose of PT01
- Female subjects must be postmenopausal (>12 months without menses) or surgically sterile (ie,by hysterectomy and/or bilateral oophorectomy) or must be using highly effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 90 days after their last dose of PT01
- Subjects who are of childbearing potential must have a negative serum pregnancy test at Screening and within 72 hours prior to the first dose
- Peripheral forearm veins suitable for venous access including cannulation for infusion of PT01 and multiple blood sampling
Who cannot join
- Eligible subjects must not have/be:
- Received prior arginase or arginine deiminase therapy
- Received recent anticancer therapy defined by:
- Chemotherapy, immunotherapy, hormonal therapy, and monoclonal antibodies (but excluding nitrosourea, mitomycin-C, targeted therapy) ≤28 days prior to starting study drug or who have not recovered from side effects of such therapy to Grade≤1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v4.03) except for subjects with alopecia; subjects receiving luteinizing hormone-releasing hormone agonists may be considered for enrollment after discussion with the Sponsor
- Last administration of nitrosourea or mitomycin-C ≤42 days prior to starting study drug or who have not recovered from the side effects of such therapy to Grade ≤1
- Targeted therapy (eg, sunitinib, sorafenib, pazopanib) ≤14 days prior to starting study drug, or who have not recovered from the side effects of such therapy to Grade ≤1
Show all 16Show fewer
- Radiotherapy ≤28 days prior to starting study drug or ≤14 days prior to starting study drug in the case of localized radiotherapy (eg, for analgesic purpose or for lytic lesions at risk of fracture) or who have not recovered from radiotherapy toxicities to Grade ≤1
- Undergone major surgery (eg, intrathoracic, intraabdominal, or intrapelvic), open biopsy, or significant traumatic injury ≤28 days prior to starting study treatment; subjects who have had minor procedures, percutaneous biopsies, or placement of vascular access device ≤7 days prior to starting study drug; or subjects who have not recovered from side effects of such procedure or injury
- Uncontrolled concurrent illness including, but not limited to, ongoing or active serious infection Athenex, Inc. Confidential Page 10 Final v2.0_17 Jun 2019 Clinical Study Protocol_Amendment 01 ATX-PT01-001 requiring systemic antimicrobials (within 14 days prior to first dose), uncontrolled arterial hypertension (>160/100 mm Hg on antihypertensive medications), chronic pulmonary disease requiring oxygen, known bleeding disorders, uncontrolled endocrine diseases, altered mental status, or psychiatric illness/social situations that would limit compliance with protocol requirements
- Significant cardiac or pulmonary disease defined by New York Heart Association Class III or IV, history of myocardial infarction within 6 months prior starting study drug, significant unstable arrhythmia, or evidence of ischemia on ECG
- Symptomatic or uncontrolled brain metastases requiring current treatment (fewer than 28 days from last cranial radiation or from last steroids use)
- Healing or open wound(s)
- Lack of recovery of prior AEs to Grade ≤1 severity (except alopecia or lymphopenia) due to medications administered prior to the first dose of study drug
- Any other condition or finding (including social situation) that, in the opinion of the Investigator, may render the subject to be either at excessive risk for treatment complications or not able to provide evaluable outcome information
- Pregnantorbreast-feedingwomen
- Known allergy to any of the formulation components of PT01
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Clinical Trials Referral Office, 855-776-0015
- Recruiting
Mayo Clinic
Phoenix, Arizona, 85054
Clinical Trials Referral Office, 855-776-0015
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015
About this study
Official title: A Phase I Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Activity o f Ascending Doses of PT0I (Pegtomarginase) in Subjects With Advanced Malignancies
This is a first-in-human (FIH) Phase 1 dose escalation study to evaluate the safety, tolerability, PK, PD, and preliminary activity of PT01 administered IV in subjects with advanced malignancies.'
Read the detailed description
The study consists of a Dose Escalation Phase and a Dose Expansion Phase, both of which include a 28-day Screening Period, Baseline, a Treatment Period (comprised of 28-day cycles with weekly dosing on Days 1, 8, 15, and 22), and a Follow-up Period. Unique to the Dose Escalation Phase is the inclusion of Cycle 0 during which a single dose of PT01 will be administered before Cycle 1 for detailed exploration of the PK/PD relationship.
All PT01 IV doses will be administered at the clinical site.
- Conditions
- Advanced Solid Malignancies
- Being tested
- PT01 (Pegtomarginase)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PT01 (Pegtomarginase)Biological
PT01 (Pegtomarginase) breaks down arginine in the blood stream, reducing the supply of arginine and stopping the cancer cells from growing. Normal cells can continue to make their own arginine inside the cell, so PT01 targets the rapidly growing cancer cells.
| Study group | Role | What they receive |
|---|---|---|
| Pegtomarginase (PT01) | Experimental | To determine the MTD of PT01 based on the toxicity observed during Cycle 1 of the Dose Escalation Phase and to investigate the safety and tolerability of PT01 when administered intravenously(IV) to subjects with advanced malignancies Receives: Biological: PT01 (Pegtomarginase) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose (MTD), and/or recommended Phase 2 dose (RP2D) together with the biologically effective dose (BED) of PT01.
Dose-limiting toxicity (DLT) for determination of MTD and/or RP2D. The grading of toxicity is based on the NCI CTCAE v4.03 criteria.
Reduction and duration of arginine for determination of BED
Measured: 4 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.3 criteria.
Number of participants with treatment related changes from baseline in vital signs, laboratory parameters and 12-lead ECG findings.
Measured: Day 1 up to 30 days post last dose
Secondary outcomes (11)
Area Under Plasma Concentration-Time Curve (AUC)
Measured: Cycle 0 Day 1: predose PT01 (Hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the PT01 IV infusion. Cycle 1 and Beyond, prepose and .5 hour post dose.
Maximum Observed Plasma Concentration (Cmax) of PT01
Measured: Cycle 0 Day 1: predose PT01 (Hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the PT01 IV infusion. Cycle 1 and Beyond, prepose and .5 hour post infusion.
The preliminary activity of PT01 by evaluating tumor response.
Tumor response according to RECIST v1.1 (best ORR for complete response [CR] and partial response [PR], stable disease, progressive disease), duration of response, PFS Tumor biomarkers in appropriate tumor types
Measured: 8 weeks
The elimination half-life (t1/2) of PT01
Measured: Cycle 0 Day 1: predose PT01 (Hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the PT01 IV infusion. Cycle 1 and Beyond, prepose and .5 hour post infusion.
The amount of PT01present at the maximum concentration in plasma (Tmax)
Measured: Cycle 0 Day 1: predose PT01 (Hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the PT01 IV infusion. Cycle 1 and Beyond, prepose and .5 hour post infusion.
The time of last quantifiable presence of PT01 in plasma(Tlast)
Measured: Cycle 0 Day 1: predose PT01 (Hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the PT01 IV infusion. Cycle 1 and Beyond, prepose and .5 hour post infusion.
PT01 concentration at the end of a dosing interval, immediately before next administration (Ctrough), the lowest observed concentration.
Measured: Cycle 0 Day 1: predose PT01 (Hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the PT01 IV infusion. Cycle 1 and Beyond, prepose and .5 hour post infusion.
The volume of PT01 distribution (Vd) in plasma.
Measured: Cycle 0 Day 1: predose PT01 (Hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the PT01 IV infusion. Cycle 1 and Beyond, prepose and .5 hour post infusion.
The total clearance of the PT01 from plasma (CL)
Measured: Cycle 0 Day 1: predose PT01 (Hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the PT01 IV infusion. Cycle 1 and Beyond, prepose and .5 hour post infusion
Duration of arginine reduction <10% of baseline.
Measured: Cycle 0 Day 1: predose PT01 (Hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the PT01 IV infusion. Cycle 1 and Beyond, prepose and .5 hour post infusion.
The absolute-percent of arginine reduction from baseline
Measured: Cycle 0 Day 1: predose PT01 (Hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the PT01 IV infusion. Cycle 1 and Beyond, prepose and .5 hour post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start21 Apr 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid MalignanciesStudies 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
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Athenex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136834
- Sponsor's protocol ID
- ATX-PT01-001
- Acronym
- PT01
- Status last verified
- Apr 2021
- First submitted
- 1 Oct 2019
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Activity o f Ascending Doses of PT0I (Pegtomarginase) in Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT04136834
- Acronym / sponsor ID
- PT01 / ATX-PT01-001
- Conditions
- Advanced Solid Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Athenex, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 23 Oct 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.
This is a first-in-human (FIH) Phase 1 dose escalation study to evaluate the safety, tolerability, PK, PD, and preliminary activity of PT01 administered IV in subjects with advanced malignancies.'
Detailed description
The study consists of a Dose Escalation Phase and a Dose Expansion Phase, both of which include a 28-day Screening Period, Baseline, a Treatment Period (comprised of 28-day cycles with weekly dosing on Days 1, 8, 15, and 22), and a Follow-up Period. Unique to the Dose Escalation Phase is the inclusion of Cycle 0 during which a single dose of PT01 will be administered before Cycle 1 for detailed exploration of the PK/PD relationship.
All PT01 IV doses will be administered at the clinical site.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegtomarginase (PT01) | Experimental | Biological: PT01 (Pegtomarginase)To determine the MTD of PT01 based on the toxicity observed during Cycle 1 of the Dose Escalation Phase and to investigate the safety and tolerability of PT01 when administered intravenously(IV) to subjects with advanced malignancies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Able to understand and voluntarily sign an informed consent form (ICF)
- Male and female adults ≥18 years of age at the time of informed consent
- Advanced solid malignancies for which no standard therapy is available. Subjects in whom available standard therapy is contraindicated may be eligible.
- For Dose Expansion Phase:
- At least 1 measurable site of disease as defined per RECIST v1.1 criteria (Dose Expansion Phase) or evaluable disease (Dose Escalation Phase only)
Key exclusion criteria (16 listed)
- Received prior arginase or arginine deiminase therapy
- Received recent anticancer therapy defined by:
- Undergone major surgery (eg, intrathoracic, intraabdominal, or intrapelvic), open biopsy, or significant traumatic injury ≤28 days prior to starting study treatment; subjects who have had minor procedures, percutaneous biopsies, or placement of vascular access device ≤7 days prior to starting study drug; or subjects who have not recovered from side effects of such procedure or injury
- Uncontrolled concurrent illness including, but not limited to, ongoing or active serious infection Athenex, Inc. Confidential Page 10 Final v2.0_17 Jun 2019 Clinical Study Protocol_Amendment 01 ATX-PT01-001 requiring systemic antimicrobials (within 14 days prior to first dose), uncontrolled arterial hypertension (>160/100 mm Hg on antihypertensive medications), chronic pulmonary disease requiring oxygen, known bleeding disorders, uncontrolled endocrine diseases, altered mental status, or psychiatric illness/social situations that would limit compliance with protocol requirements
- Significant cardiac or pulmonary disease defined by New York Heart Association Class III or IV, history of myocardial infarction within 6 months prior starting study drug, significant unstable arrhythmia, or evidence of ischemia on ECG
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 |
|---|---|---|
| PT01 (Pegtomarginase)PT01 (Pegtomarginase) breaks down arginine in the blood stream, reducing the supply of arginine and stopping the cancer cells from growing. Normal cells can continue to make their own arginine inside the cell, so PT01 targets the rapidly growing cancer cells. | Biological | Pegtomarginase (PT01) |
Primary outcome
The maximum tolerated dose (MTD), and/or recommended Phase 2 dose (RP2D) together with the biologically effective dose (BED) of PT01.
Time frame: 4 weeks
Dose-limiting toxicity (DLT) for determination of MTD and/or RP2D. The grading of toxicity is based on the NCI CTCAE v4.03 criteria. Reduction and duration of arginine for determination of BED
Number of participants with treatment-related adverse events as assessed by CTCAE v4.3 criteria.
Time frame: Day 1 up to 30 days post last dose
Number of participants with treatment related changes from baseline in vital signs, laboratory parameters and 12-lead ECG findings.
11 secondary outcomes
Area Under Plasma Concentration-Time Curve (AUC)
Time frame: Cycle 0 Day 1: predose PT01 (Hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the PT01 IV infusion. Cycle 1 and Beyond, prepose and .5 hour post dose.
Maximum Observed Plasma Concentration (Cmax) of PT01
Time frame: Cycle 0 Day 1: predose PT01 (Hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the PT01 IV infusion. Cycle 1 and Beyond, prepose and .5 hour post infusion.
The preliminary activity of PT01 by evaluating tumor response.
Time frame: 8 weeks
The elimination half-life (t1/2) of PT01
Time frame: Cycle 0 Day 1: predose PT01 (Hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the PT01 IV infusion. Cycle 1 and Beyond, prepose and .5 hour post infusion.
The amount of PT01present at the maximum concentration in plasma (Tmax)
Time frame: Cycle 0 Day 1: predose PT01 (Hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the PT01 IV infusion. Cycle 1 and Beyond, prepose and .5 hour post infusion.
The time of last quantifiable presence of PT01 in plasma(Tlast)
Time frame: Cycle 0 Day 1: predose PT01 (Hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the PT01 IV infusion. Cycle 1 and Beyond, prepose and .5 hour post infusion.
PT01 concentration at the end of a dosing interval, immediately before next administration (Ctrough), the lowest observed concentration.
Time frame: Cycle 0 Day 1: predose PT01 (Hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the PT01 IV infusion. Cycle 1 and Beyond, prepose and .5 hour post infusion.
The volume of PT01 distribution (Vd) in plasma.
Time frame: Cycle 0 Day 1: predose PT01 (Hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the PT01 IV infusion. Cycle 1 and Beyond, prepose and .5 hour post infusion.
The total clearance of the PT01 from plasma (CL)
Time frame: Cycle 0 Day 1: predose PT01 (Hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the PT01 IV infusion. Cycle 1 and Beyond, prepose and .5 hour post infusion
Duration of arginine reduction <10% of baseline.
Time frame: Cycle 0 Day 1: predose PT01 (Hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the PT01 IV infusion. Cycle 1 and Beyond, prepose and .5 hour post infusion.
The absolute-percent of arginine reduction from baseline
Time frame: Cycle 0 Day 1: predose PT01 (Hour 0) and at 0.5 (end of infusion), 2, 4, 8, 24, 48, 72, 168, and 240 hours after the start of the PT01 IV infusion. Cycle 1 and Beyond, prepose and .5 hour post infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Individual participant dataSharing planned: No
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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.
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 PT01 (Pegtomarginase) in people with Advanced Solid Malignancies, run by Athenex, 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 26 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 17 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donna Madore (5088264444, ext-dmadore@athenex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum tolerated dose (MTD), and/or recommended Phase 2 dose (RP2D) together with the biologically effective dose (BED) of PT01. (time frame: 4 weeks). 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 17 Aug 2021.