Solid TumorPhase 1NCT02963168
A DRF Study to Evaluate Safety, Tolerability, PK, and Activity of Oradoxel Monotherapy in Subjects w Adv. Malignancies
A Phase 1 study testing Oradoxel in people with Solid Tumor, run by Athenex, Inc. at 3 sites in United States.
Trial summary
This is a nonrandomized, open-label, dose escalation, safety, activity, and PK study to determine the MTD and optimal dosing regimen of Oradoxel. No control group has been included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Oradoxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Apr 2017to 30 Apr 2020
- 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
- Signed written informed consent
- ≥18 years of age
- Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
- Docetaxel monotherapy is a reasonable treatment in the judgement of the Investigator
- Measurable disease as per RECIST v1.1 criteria
- Able to swallow oral medication as an intact dosage form
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- Adequate hematologic status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain: Absolute neutrophil count (ANC) ≥1500 cells/mm3, Platelet count ≥100 x 109/L, Hemoglobin (Hgb) ≥10 g/dL
- Adequate liver function as demonstrated by: Total bilirubin of < upper limit of normal (ULN), Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤1.5 × ULN, Alkaline phosphatase (ALP) ≤2.5x ULN or <5x ULN if bone metastases are present, Normal serum albumin
- Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN or creatinine clearance>60 mL/min as calculated by the Cockroft and Gault formula
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Life expectancy of at least 3 months
- Willing to fast for 6 hours before and 2 hours after Oradoxel administration
- Females must be postmenopausal (>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or, if sexually active, must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after their last dose of study drug.
- Sexually active male subjects must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of study drug.
Who cannot join
- Currently taking a prohibited concomitant medication, other than a premedication, that are/is:
- Strong inhibitors (eg, ketoconazole) or inducers (eg, rifampicin or St. John's Wort) of CYP3A4 (within 2 weeks prior to the start of dosing in the study)
- Strong P-gp inhibitors or inducers. Subjects who are taking such medications but who are otherwise eligible may be enrolled if they discontinue the medication ≥1 week before dosing and remain off that medication through the end of PK sampling after the administration of the second study treatment
- An oral medication with a narrow therapeutic index known to be a P-gp substrate within 24 hours prior to start of dosing in the study
- Unresolved toxicity from prior chemotherapy (subjects must be recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products.
- Planning to receive other medical, surgical, or radiological cancer treatments during the course of this study
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- Received investigational agents within 14 days or 5 half-lives prior to the first study dosing day, whichever is longer
- Require therapeutic use of anticoagulants
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, clinically significant myocardial infarction within the last 6 months, unstable angina pectoris, clinically significant cardiac arrhythmia, bleeding disorder, chronic pulmonary disease requiring oxygen, or psychiatric illness/social situations that would limit compliance with study requirements
- Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease or other medical condition that, in the opinion of the Investigator, may interfere with oral drug absorption
- A known history of allergy to docetaxel, Cremophor or polysorbate 80 (Tween 80)
- Evidence of fluid retention at Screening (including, for example, peripheral edema, pleural effusion, or ascites on physical or radiological examination) or history of severe capillary leak syndrome
- Any other condition which the Investigator believes would make participation in the study not acceptable
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Mayo Clinic
Phoenix, Arizona, 85054
Clinical Trials Referral Office, 855-776-0015
Parminder Singh, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015
- Recruiting
Cancer Therapy & Research Center at UTHSCSA
San Antonio, Texas, 78229
Clinical Trials Office, 210-450-1000
John Sarantopoulos, MD
About this study
Official title: A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oradoxel Monotherapy in Subjects With Advanced Malignancies
This is a nonrandomized, open-label, dose escalation, safety, activity, and PK study to determine the MTD and optimal dosing regimen of Oradoxel. No control group has been included.
Read the detailed description
This is a multicenter, open-label, safety, tolerability, pharmacokinetic, and activity study. Eligible subjects will be adults with advanced solid malignancies.
Groups of 3 to 6 subjects will receive a single dose of Oradoxel and will be followed for toxicity. If non linearity in PK is observed, additional subjects will receive Oradoxel as 2 single daily doses once every three weeks. Subjects who tolerate the drug and have stable disease or better response will be eligible to receive ongoing treatment.
- Conditions
- Solid Tumor
- Being tested
- Oradoxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OradoxelDrug
Also called oral docetaxel + oral HM30181A
oral docetaxel will be supplied in capsules and oral HM30181A-UK tablets
| Study group | Role | What they receive |
|---|---|---|
| Oradoxel | Experimental | To determine the MTD of Oradoxel (oral docetaxel and oral HM30181A) when administered once every 3 weeks, then to determine the MTD of Oradoxel (oral docetaxel and oral HM30181A) when administered for two days every three weeks. Receives: Drug: Oradoxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose (MTD) of Oradoxel based on dose-limiting toxicity (DLT) in subjects with advanced malignancies
The MTD will be the highest dose at which no more than 1 of 6 subjects experience a DLT during treatment and Oradoxel pharmacokinetics are acceptable.
Measured: 3 weeks
Secondary outcomes (16)
Safety assessment using AEs of Oradoxel
Measured: Weekly, up to 24 months
Safety assessment using SAEs of Oradoxel
Measured: Weekly, up to 24 months
Laboratory evaluation for hematology
Measured: Weekly, up to 24 months
Blood chemistry
Measured: Weekly, up to 24 months
Urine analysis
Measured: Weekly, up to 24 months
Periodic measurements of ECGs
Measured: Screening, Day 1, every 6 weeks thereafter up to 24 months
Periodic measurements of vital signs
Measured: Weekly, up to 24 months
The incidence of unacceptable toxicity with Oradoxel
Unacceptable toxicity graded according to CTCAE v4.03
Measured: 24 months
The recommended Phase 2 dose (RP2D) of Oradoxel
Upon determination of the overall MTD for Oradoxel, the safety and PK profile of the study treatment from all Treatment Periods will be reviewed to determine the recommended Phase 2 dose.
Measured: 24 months
The amount of docetaxel and HM30181A in blood stream by Area under the plasma concentration versus time curve (AUC)
Measured: Part 1: 16 timepoints over 504 hours; Part 2: 26 timepoints over 480 hours
The peak plasma concentration (Cmax) and Minimum plasma concentration (Cmin)
Measured: Part 1: 16 timepoints over 504 hours; Part 2: 26 timepoints over 480 hours
A biological half-life or elimination half-life (t1/2)
Measured: Part 1: 16 timepoints over 504 hours; Part 2: 26 timepoints over 480 hours
The accumulation ratio (R)
Measured: Part 1: 16 timepoints over 504 hours; Part 2: 26 timepoints over 480 hours
The apparent total clearance of the drug from plasma (CL/F)
Measured: Part 1: 16 timepoints over 504 hours; Part 2: 26 timepoints over 480 hours
The apparent volume of distribution (Vd/F)
Measured: Part 1: 16 timepoints over 504 hours; Part 2: 26 timepoints over 480 hours
To evaluate tumor response
Tumor response will be evaluated according to RECIST v1.1
Measured: Every 12 weeks, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study start20 Apr 2017
- Primary completion30 Mar 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Athenex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Cutler, MD, Study director, Athenex, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963168
- Sponsor's protocol ID
- KX-ORADOX-003
- Status last verified
- Jan 2019
- First submitted
- 7 Oct 2016
- Last updated
- 17 Oct 2019
- 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 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oradoxel Monotherapy in Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT02963168
- Acronym / sponsor ID
- KX-ORADOX-003
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Athenex, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 30 Mar 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 15 Nov 2016 (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 is a nonrandomized, open-label, dose escalation, safety, activity, and PK study to determine the MTD and optimal dosing regimen of Oradoxel. No control group has been included.
Detailed description
This is a multicenter, open-label, safety, tolerability, pharmacokinetic, and activity study. Eligible subjects will be adults with advanced solid malignancies.
Groups of 3 to 6 subjects will receive a single dose of Oradoxel and will be followed for toxicity. If non linearity in PK is observed, additional subjects will receive Oradoxel as 2 single daily doses once every three weeks. Subjects who tolerate the drug and have stable disease or better response will be eligible to receive ongoing treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oradoxel | Experimental | Drug: OradoxelTo determine the MTD of Oradoxel (oral docetaxel and oral HM30181A) when administered once every 3 weeks, then to determine the MTD of Oradoxel (oral docetaxel and oral HM30181A) when administered for two days every three weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed written informed consent
- ≥18 years of age
- Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
- Docetaxel monotherapy is a reasonable treatment in the judgement of the Investigator
- Measurable disease as per RECIST v1.1 criteria
Key exclusion criteria (13 listed)
- Currently taking a prohibited concomitant medication, other than a premedication, that are/is:
- Unresolved toxicity from prior chemotherapy (subjects must be recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products.
- Planning to receive other medical, surgical, or radiological cancer treatments during the course of this study
- Received investigational agents within 14 days or 5 half-lives prior to the first study dosing day, whichever is longer
- Require therapeutic use of anticoagulants
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 |
|---|---|---|
| OradoxelAlso: oral docetaxel + oral HM30181Aoral docetaxel will be supplied in capsules and oral HM30181A-UK tablets | Drug | Oradoxel |
Primary outcome
The maximum tolerated dose (MTD) of Oradoxel based on dose-limiting toxicity (DLT) in subjects with advanced malignancies
Time frame: 3 weeks
The MTD will be the highest dose at which no more than 1 of 6 subjects experience a DLT during treatment and Oradoxel pharmacokinetics are acceptable.
16 secondary outcomes
Safety assessment using AEs of Oradoxel
Time frame: Weekly, up to 24 months
Safety assessment using SAEs of Oradoxel
Time frame: Weekly, up to 24 months
Laboratory evaluation for hematology
Time frame: Weekly, up to 24 months
Blood chemistry
Time frame: Weekly, up to 24 months
Urine analysis
Time frame: Weekly, up to 24 months
Periodic measurements of ECGs
Time frame: Screening, Day 1, every 6 weeks thereafter up to 24 months
Periodic measurements of vital signs
Time frame: Weekly, up to 24 months
The incidence of unacceptable toxicity with Oradoxel
Time frame: 24 months
The recommended Phase 2 dose (RP2D) of Oradoxel
Time frame: 24 months
The amount of docetaxel and HM30181A in blood stream by Area under the plasma concentration versus time curve (AUC)
Time frame: Part 1: 16 timepoints over 504 hours; Part 2: 26 timepoints over 480 hours
The peak plasma concentration (Cmax) and Minimum plasma concentration (Cmin)
Time frame: Part 1: 16 timepoints over 504 hours; Part 2: 26 timepoints over 480 hours
A biological half-life or elimination half-life (t1/2)
Time frame: Part 1: 16 timepoints over 504 hours; Part 2: 26 timepoints over 480 hours
The accumulation ratio (R)
Time frame: Part 1: 16 timepoints over 504 hours; Part 2: 26 timepoints over 480 hours
The apparent total clearance of the drug from plasma (CL/F)
Time frame: Part 1: 16 timepoints over 504 hours; Part 2: 26 timepoints over 480 hours
The apparent volume of distribution (Vd/F)
Time frame: Part 1: 16 timepoints over 504 hours; Part 2: 26 timepoints over 480 hours
To evaluate tumor response
Time frame: Every 12 weeks, up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- 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.
David Cutler, MD study director
Athenex, 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 Oradoxel in people with Solid Tumor, 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 14 inclusion and 13 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 Oct 2019. 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 E. Douglas Kramer, MD (908-340-6996, dkramer@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) of Oradoxel based on dose-limiting toxicity (DLT) in subjects with advanced malignancies (time frame: 3 weeks). 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 Oct 2019; AzTrials last refreshed its copy on 29 Oct 2026.