Solid TumorPhase 1NCT02730481
A Study to Evaluate the Safety, Tolerability, MTD, PK, and Activity of Oraxol in Subjects w Adv. Malignancies
A Phase 1 study testing Oraxol in people with Solid Tumor, run by Athenex, Inc. at 3 sites in United States.
Trial summary
This is a multicenter, open-label, safety study. Eligible subjects will be adults with advanced malignancies. The study includes a pretreatment and treatment phase. The pretreatment phase consists of screening and baseline periods. The treatment phase consists of 4-week treatment periods and a follow-up period. 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?
- Oraxol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2016to May 2021
- 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
- Measurable disease as per RECIST v1.1 criteria
- Adequate hematologic status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain: ANC ≥1500 cells/mm3, Platelet count ≥100 x 109/L, Hemoglobin ≥9 g/dL
- Adequate liver function as demonstrated by:Total bilirubin of ≤1.5 mg/dL or ≤2.0 mg/dL for subjects with liver metastasis, Alanine aminotransferase ≤3 x upper limit of normal (ULN) or ≤5 x ULN if liver metastasis is present, Alkaline phosphatase ≤3 x ULN or ≤5 x ULN if bone or liver metastasis is present
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- Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN or creatinine clearance calculation ≥60 mL/min as calculated by the Cockcroft and Gault formula
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Life expectancy of at least 3 months
- Women must be postmenopausal (>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or 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
- Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)
- Received IPs within 30 days or 5 half lives of the first study dosing day
- Are currently receiving other medications or radiation intended for the treatment of their malignancy
- Women of childbearing potential who are pregnant or breastfeeding
- Currently taking a concomitant medication
- Require therapeutic use of anticoagulation medications
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- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia, chronic pulmonary disease requiring oxygen, known bleeding disorders, or any concomitant illness or social situation 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
- History of hypersensitivity to paclitaxel, not attributed to a hypersensitivity type reaction to Cremophor
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14263
Cancer Therapy &Research Center @ UTHSCSA
San Antonio, Texas, 78229
About this study
Official title: A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Maximum Tolerated Dose, Pharmacokinetics, and Activity of Oraxol in Subjects With Advanced Malignancies
This is a multicenter, open-label, safety study. Eligible subjects will be adults with advanced malignancies. The study includes a pretreatment and treatment phase. The pretreatment phase consists of screening and baseline periods. The treatment phase consists of 4-week treatment periods and a follow-up period.
- Conditions
- Solid Tumor
- Being tested
- Oraxol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OraxolDrug
Also called Paclitaxel and HM30181AK-US
Oraxol will be supplied as paclitaxel capsules and HM30181AK-US tablets.
| Study group | Role | What they receive |
|---|---|---|
| ORAXOL | Experimental | Oraxol (paclitaxel + HM30181AK-US) Oraxol paclitaxel - supplied as 30-mg capsules
Oraxol HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets Receives: Drug: Oraxol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of Oraxol
The highest dose at which no more than 1 of 6 subjects experience a dose-limiting toxicity (DLT) during treatment
Measured: 20 weeks
Secondary outcomes (4)
Evaluate tumor response
RECIST v1.1 criteria defined as complete response, partial response, stable disease or progressive disease
Measured: At baseline and every 8 weeks through study completion, approximately 24 months
Number of Participants with abnormal laboratory values and/or adverse events that are related to treatment
Number of Participants with abnormal laboratory values and/or adverse events that are related to treatment
Measured: 4 weeks
The amount of Oraxol in the blood stream
The measurement of Oraxol levels in the blood stream over time
Measured: 3 weeks
The recommended Phase 2 dose of paclitaxel as Oraxol
The totality of information from the number of participants that reach the MTD (outcome #1), the number of participants that experience abnormal laboratory values and/or adverse events that are related to treatment (outcome #3), and the amount of Oraxol in the blood stream in participants (outcome #4)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2021
- Study completionMay 2021
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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athenex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- E D Kramer, MD, Study director, Kinex Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730481
- Sponsor's protocol ID
- KX-ORAX-004
- Status last verified
- Sep 2021
- First submitted
- 3 Mar 2016
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. 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, Maximum Tolerated Dose, Pharmacokinetics, and Activity of Oraxol in Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT02730481
- Acronym / sponsor ID
- KX-ORAX-004
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Athenex, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 6 Apr 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 multicenter, open-label, safety study. Eligible subjects will be adults with advanced malignancies. The study includes a pretreatment and treatment phase. The pretreatment phase consists of screening and baseline periods. The treatment phase consists of 4-week treatment periods and a follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ORAXOL | Experimental | Drug: OraxolOraxol (paclitaxel + HM30181AK-US) Oraxol paclitaxel - supplied as 30-mg capsules Oraxol HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 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
- Measurable disease as per RECIST v1.1 criteria
- Adequate hematologic status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain: ANC ≥1500 cells/mm3, Platelet count ≥100 x 109/L, Hemoglobin ≥9 g/dL
Key exclusion criteria (9 listed)
- Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)
- Received IPs within 30 days or 5 half lives of the first study dosing day
- Are currently receiving other medications or radiation intended for the treatment of their malignancy
- Women of childbearing potential who are pregnant or breastfeeding
- Currently taking a concomitant medication
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 |
|---|---|---|
| OraxolAlso: Paclitaxel and HM30181AK-USOraxol will be supplied as paclitaxel capsules and HM30181AK-US tablets. | Drug | ORAXOL |
Primary outcome
Maximum tolerated dose (MTD) of Oraxol
Time frame: 20 weeks
The highest dose at which no more than 1 of 6 subjects experience a dose-limiting toxicity (DLT) during treatment
4 secondary outcomes
Evaluate tumor response
Time frame: At baseline and every 8 weeks through study completion, approximately 24 months
Number of Participants with abnormal laboratory values and/or adverse events that are related to treatment
Time frame: 4 weeks
The amount of Oraxol in the blood stream
Time frame: 3 weeks
The recommended Phase 2 dose of paclitaxel as Oraxol
Time frame: 24 months
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 13 Sep 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.
E D Kramer, MD study director
Kinex 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 Oraxol 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 11 inclusion and 9 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 13 Sep 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?
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?
Maximum tolerated dose (MTD) of Oraxol (time frame: 20 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 13 Sep 2021.