Solid TumorPhase 1NCT01967043
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies
A Phase 1 study testing Oraxol in people with Solid Tumor, run by Kinex Pharmaceuticals Inc. at 3 sites in United States.
Trial summary
This is a standard "3+3" Phase 1b study to determine the MTD of Oraxol (paclitaxel + HM30181 Methanesulfonate monohydrate) in subjects with advanced malignancies that may be metastatic or unresectable with measurable malignant lesion(s) per RECIST Version 1.1 criteria. 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
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2013to Sep 2016
- 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 Version 1.1 criteria.
- Adequate bone marrow reserve as demonstrated by
- Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L
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- Platelet count ≥ 100 x 10⁹/L
- Hemoglobin (Hgb) ≥ 9 g/L
- 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 (ALT)≤ 3 x upper limit of normal (ULN) or ≤ 5x ULN if liver metastasis is present
- ALP ≤ 3 x ULN or ≤ 5 x ULN if bone metastasis is present
- Adequate renal function as demonstrated by serum creatinine ≤ 1.5 x ULN, or 24-hr urine creatinine clearance calculation >60 mL/min
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Life expectancy of at least 3 months
- Subjects who are not currently taking prohibited medication
- Women must be postmenopausal (> 12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception
Who cannot join
- Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational agents
- Received investigational agents within 14 days or 5 half-lives of the first study dosing day, whichever is longer.
- Women of childbearing potential who are pregnant or breast feeding.
- 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 psychiatric illness/social situations that would limit compliance with study requirements
- Significant or uncontrolled cardiovascular disease or bleeding disorder
- 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
- Subjects with a known history of allergy to paclitaxel. Subjects whose allergy was due to the IV solvent (such as Cremophor®) and not paclitaxel will be eligible for this study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado Cancer Center
Aurora, Colorado, 800045
Johns Hopkins University
Baltimore, Maryland, 21205
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies
This is a standard "3+3" Phase 1b study to determine the MTD of Oraxol (paclitaxel + HM30181 Methanesulfonate monohydrate) in subjects with advanced malignancies that may be metastatic or unresectable with measurable malignant lesion(s) per RECIST Version 1.1 criteria.
- 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
Oraxol (Paclitaxel + HM30181AK). Paclitaxel will be supplied as 30 mg capsules and HM30181AK-US will be supplied as 15 mg tablets.
| Study group | Role | What they receive |
|---|---|---|
| Oraxol Arm 1 | Experimental | HM30181AK-US tablet administered as a single oral dose of xmg on Days x, y, and z of each cycle
Paclitaxel administered as a fixed oral daily dose of xmg (nine xmg capsules) starting on Days x, y, and z of each cycle. Depending on the cohort, subjects will receive 2, 3, 4, or 5 consecutive days of paclitaxel per week. Receives: Drug: Oraxol |
| Oraxol Arm 2 | Experimental | HM30181AK-US tablet administered as a single oral dose of xmg daily with each dose of Paclitaxel
Paclitaxel administered as a fixed oral daily dose of xmg (nine xmg capsules) starting on Days x, y, and z of each cycle. Depending on the cohort, subjects will receive 2, 3, 4, or 5 consecutive days of paclitaxel per week. Receives: Drug: Oraxol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) of Oraxol in subjects with advanced malignancies
Measured: one year
Secondary outcomes (1)
To determine the recommended Phase 2 dose (RP2D) of Oraxol
Measured: one year six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2016
- Study completionSep 2016
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kinex Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantic Research Group
- Responsible party
- Sponsor
- Investigators
- Min-Fun Rudolf Kwan, MD, Study director, Kinex Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967043
- Sponsor's protocol ID
- ORAX-01-13-US
- Status last verified
- Dec 2016
- First submitted
- 18 Sep 2013
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT01967043
- Acronym / sponsor ID
- ORAX-01-13-US
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Kinex Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- Atlantic Research Group
- Study start
- Oct 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 22 Oct 2013 (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 standard "3+3" Phase 1b study to determine the MTD of Oraxol (paclitaxel + HM30181 Methanesulfonate monohydrate) in subjects with advanced malignancies that may be metastatic or unresectable with measurable malignant lesion(s) per RECIST Version 1.1 criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oraxol Arm 1 | Experimental | Drug: OraxolHM30181AK-US tablet administered as a single oral dose of xmg on Days x, y, and z of each cycle Paclitaxel administered as a fixed oral daily dose of xmg (nine xmg capsules) starting on Days x, y, and z of each cycle. Depending on the cohort, subjects will receive 2, 3, 4, or 5 consecutive days of paclitaxel per week. |
| Oraxol Arm 2 | Experimental | Drug: OraxolHM30181AK-US tablet administered as a single oral dose of xmg daily with each dose of Paclitaxel Paclitaxel administered as a fixed oral daily dose of xmg (nine xmg capsules) starting on Days x, y, and z of each cycle. Depending on the cohort, subjects will receive 2, 3, 4, or 5 consecutive days of paclitaxel per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 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 Version 1.1 criteria.
- Adequate bone marrow reserve as demonstrated by
Key exclusion criteria (7 listed)
- Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational agents
- Received investigational agents within 14 days or 5 half-lives of the first study dosing day, whichever is longer.
- Women of childbearing potential who are pregnant or breast feeding.
- 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 psychiatric illness/social situations that would limit compliance with study requirements
- Significant or uncontrolled cardiovascular disease or bleeding disorder
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 |
|---|---|---|
| OraxolOraxol (Paclitaxel + HM30181AK). Paclitaxel will be supplied as 30 mg capsules and HM30181AK-US will be supplied as 15 mg tablets. | Drug | Oraxol Arm 1, Oraxol Arm 2 |
Primary outcome
To determine the maximum tolerated dose (MTD) of Oraxol in subjects with advanced malignancies
Time frame: one year
1 secondary outcome
To determine the recommended Phase 2 dose (RP2D) of Oraxol
Time frame: one year six 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 16 Dec 2016.
- 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.
Min-Fun Rudolf Kwan, 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 Kinex Pharmaceuticals 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 17 inclusion and 7 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 16 Dec 2016. 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?
To determine the maximum tolerated dose (MTD) of Oraxol in subjects with advanced malignancies (time frame: one year). 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 16 Dec 2016.