Gastric CancerPhase 1NCT02970539
Ph1b Study of Oraxol in Comb. w. Ramucirumab in Patients w. Gastric, Gastro-esophageal, or Esophageal Cancers
A Phase 1 study testing Oraxol and Ramucirumab in people with Gastric Cancer and Esophageal Cancer, run by Athenex, Inc. at 5 sites in 2 countries.
Trial summary
This is a nonrandomized, open-label, single group assignment, safety, tolerability and pharmacokinetic (PK) study to determine the MTD and optimal dosing regimen of Oraxol in combination with ramucirumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Esophageal Cancer, Gastro-esophageal Cancer
- What is being tested?
- Oraxol and Ramucirumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 8 Dec 2016to 31 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
- Subjects must meet all of the following criteria to be included in this study:
- 1. Signed written informed consent 2. ≥18 years of age 3. Histologically or cytologically confirmed diagnosis of advanced stage gastric, gastro-esophageal (Part 1 or Part 2), or esophageal adenocarcinoma (Part 1 only) with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy 4. Have documented testing for HER2-neu overexpression, and for those with tumors overexpressing HER2-neu, have documented progression on Trastuzumab-containing therapy 5. Measurable disease on computed tomography (CT) scan of thorax, abdomen, and pelvis, per RECIST v1.1 criteria 6. Able to swallow oral medication as an intact dosage form 7. 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 ≥10 g/dL; subjects with thalassemia having a hemoglobin <10 g/dL may be enrolled, per Investigator discretion 8. Adequate liver function as demonstrated by:
- Total bilirubin of ≤1.5 mg/dL
Show all 13Show fewer
- Alanine aminotransferase (ALT) ≤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
- Gamma-glutamyl transferase (GGT) <10 x ULN 9. 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
- Urinary protein ≤1+. If urinary protein is ≥2+, a 24-hour urine collection for protein must demonstrate <1000 mg of protein in 24 hours to allow participation in this protocol.
- 10. Normal prothrombin time (PT) or international normalized ratio (INR) and normal activated partial thromboplastin time (aPTT) unless subject is on anticoagulation therapy 11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 12. Life expectancy of at least 3 months 13. 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.
- 14. 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
- Subjects who meet any of the following criteria will be excluded from this study:
- Unresolved toxicity from previous anticancer treatments, including investigational products (subjects must have recovered all unacceptable toxicity to ≤ Grade 1 Common Terminology Criteria for Adverse Events [CTCAE] toxicity). This does not extend to symptoms or findings that are attributable to the underlying disease.
- Received investigational products within 14 days or 5 half-lives of the first study dosing day, whichever is longer; subjects receiving biologic agents (eg, monoclonal antibodies) require a 30-day washout period.
- Are currently receiving other medications or radiation intended for the treatment of their malignancy
- Central nervous system metastases, including leptomeningeal involvement
- Women of childbearing potential who are pregnant or breastfeeding
Show all 25Show fewer
- Currently taking a concomitant medication, other than a premedication, that is:
- A strong P-glycoprotein (P-gp) inhibitor or inducer. Subjects who are taking such medications but who are otherwise eligible may be enrolled if they discontinue the medication ≥1 week before dosing
- 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
- Medications known to be strong inhibitors (gemfibrozil) or inducers (rifampin) of cytochrome P450 (CYP) 2C8 or medications known to be strong CYP3A4 inhibitors (eg, ketoconazole) or inducers (eg, rifampin or St. John's Wort). Subjects who are currently 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 during treatment with Oraxol.
- Use of warfarin. Participants receiving warfarin who are otherwise eligible and who may be appropriately managed with low molecular weight heparin, in the opinion of the Investigator, may be enrolled in the study provided they are switched to low molecular weight heparin at least 7 days prior to receiving study treatment.
- Require chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs), chronic antiplatelet therapy, dipyridamole, clopidogrel, or similar agents. Aspirin up to 325 mg per day is allowed.
- Unable to receive iv contrast for required CT scans
- Poorly-controlled hypertension (>160 mm Hg systolic or >100 mm Hg diastolic for >4 weeks) despite standard medical management. Subjects may be rescreened after adjustment of their antihypertensive medication.
- Serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to first dose of protocol therapy
- Prior history of GI perforation/fistula (within 6 months of first dose of protocol therapy) or risk factors for perforation
- Grade 3 or 4 GI bleeding within 3 months prior to first dose of protocol therapy
- Arterial thromboembolic event including, but not limited to, myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina within 6 months prior to first dose of protocol therapy
- Deep vein thrombosis (DVT) or pulmonary embolus or any other significant thromboembolic event during the 3 months prior to first dose of protocol therapy
- Child-Pugh Class B or C cirrhosis of the liver or cirrhosis (any degree) and a history of hepatic encephalopathy or a history of ascites resulting from cirrhosis requiring diuretics or paracentesis
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, poorly controlled diabetes or diabetes with established vascular complications, chronic pulmonary disease requiring oxygen, known bleeding disorders, or any concomitant illness or social situation that would limit compliance with study requirements
- Medical condition that, in the opinion of the investigator, may interfere with oral drug absorption
- Major surgery within 28 days prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement within 7 days prior to the first dose of protocol therapy, or elective or major surgery planned to be performed during the course of the clinical trial
- History of hypersensitivity to paclitaxel, not attributed to a hypersensitivity type reaction to Cremophor®, or history of hypersensitivity type reaction to polysorbate 80 or other components of the formulation of Oraxol
- History of developing any condition during prior treatment with ramucirumab for which ramucirumab must be permanently discontinued according to the ramucirumab Investigator's Brochure
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Taiwan4 sites
China Medical University Hospital
Taichung
Tri-Service General Hospital
Taipei, 11490
Taipei Veterans General Hospital
Taipei
Lotung Poh-Ai Hospital
Yilan, 26546
About this study
Official title: A Phase 1b Study of Oraxol in Combination With Ramucirumab in Patients With Gastric, Gastro-esophageal, or Esophageal Cancers
This is a nonrandomized, open-label, single group assignment, safety, tolerability and pharmacokinetic (PK) study to determine the MTD and optimal dosing regimen of Oraxol in combination with ramucirumab.
Read the detailed description
This is a sequential-group, dose escalation trial to determine the maximum tolerated dose of oral Oraxol in combination with intravenous ramucirumab. After a screening period of up to 28 days subjects will be enrolled into the treatment phase of the study. Each cycle of therapy will last 4 weeks. Subjects may continue in the study until they experience disease progression or unacceptable toxicity. Three to six subjects will be enrolled at each dose level. Once the tolerability of a dose level has been determined, an additional 3-6 subjects may be enrolled at a higher dose level, to determine the maximum tolerated dose. Safety will be monitored through recording of adverse events, serious adverse events, monitoring of laboratory tests including hematology, blood chemistry, urinalyses, physical examinations and electrocardiograms. Subjects will undergo radiographic assessments for tumor response at specified time points. Blood samples will also be obtained in the first cycle of therapy at multiple time points for determination of the amount of paclitaxel and metabolites and HM30181 in the circulation. After the treatment period, there will be a follow-up period during which the subject or family may be contacted every three months for follow-up.
- Conditions
- Gastric Cancer, Esophageal Cancer, Gastro-esophageal Cancer
- Being tested
- Oraxol, Ramucirumab
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OraxolDrug
Also called oral HM30181AK-US tablet and paclitaxel capsule
Oraxol (Paclitaxel and HM30181A) will be dosed orally. Paclitaxel will be supplied as capsules and HM30181A will be supplied as tablets.
RamucirumabDrug
Also called LY3009806
Ramucirumab will be administered by iv infusion and supplied as a solution at a concentration of 10 mg/mL
| Study group | Role | What they receive |
|---|---|---|
| Oraxol +Ramucirumab | Experimental | Oraxol (oral HM30181 + oral paclitaxel)
* HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets
* Paclitaxel - supplied as 30-mg capsules Ramucirumab - supplied as a solution at a concentration of 10 mg/mL Receives: Drug: Oraxol; Drug: Ramucirumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
The primary endpoint of determining the MTD will be based on DLT
Measured: The first 4 weeks
Secondary outcomes (13)
To determine the safety and tolerability of Oraxol in combination with ramucirumab
Safety assessments will consist of determining and recording all AEs (including for both increasing and decreasing severity) and SAEs
Measured: through study completion
The recommended Phase 2 dose of Oraxol in combination with ramucirumab
Evaluation of the 3-day MTD for Oraxol in combination with ramucirumab, including safety, tolerability, and pharmacokinetics, will be used to determine the recommended Phase 2 dose
Measured: One month
To characterize the area under the blood concentration curve (AUCt) of Oraxol in combination with ramucirumab
Derived by noncompartmental analysis using the plasma concentration-time data of Oraxol (paclitaxel and its major metabolites, 3'-p-hydroxy paclitaxel and 6α-hydroxy paclitaxel, and HM30181 methanesulfonate monohydrate and its M1 metabolite)
Measured: Day 1 and 3: Predose, 8 timepoints up to 8 hours postdose; Day 2: Predose; Day 8 and 15: Predose, and between 1 and 3 hours postdose
To characterize the area under the plasma concentration-time curve from 0 to 8 hours (AUC0-8h) of Oraxol in combination with ramucirumab
Derived by noncompartmental analysis using the plasma concentration-time data of Oraxol (paclitaxel and its major metabolites, 3'-p-hydroxy paclitaxel and 6α-hydroxy paclitaxel, and HM30181 methanesulfonate monohydrate and its M1 metabolite)
Measured: Day 1 and 3: Predose, 8 timepoints up to 8 hours postdose; Day 2: Predose; Day 8 and 15: Predose, and between 1 and 3 hours postdose
To characterize the maximum observed plasma concentration (Cmax) of Oraxol in combination with ramucirumab
Derived by noncompartmental analysis using the plasma concentration-time data of Oraxol (paclitaxel and its major metabolites, 3'-p-hydroxy paclitaxel and 6α-hydroxy paclitaxel, and HM30181 methanesulfonate monohydrate and its M1 metabolite)
Measured: Day 1 and 3: Predose, 8 timepoints up to 8 hours postdose; Day 2: Predose; Day 8 and 15: Predose, and between 1 and 3 hours postdose
To characterize the minimum observed plasma concentration (Cmin) of Oraxol in combination with ramucirumab
Derived by noncompartmental analysis using the plasma concentration-time data of Oraxol (paclitaxel and its major metabolites, 3'-p-hydroxy paclitaxel and 6α-hydroxy paclitaxel, and HM30181 methanesulfonate monohydrate and its M1 metabolite)
Measured: Day 1 and 3: Predose, 8 timepoints up to 8 hours postdose; Day 2: Predose; Day 8 and 15: Predose, and between 1 and 3 hours postdose
To characterize the plasma half-life (t1/2) of Oraxol in combination with ramucirumab
Derived by noncompartmental analysis using the plasma concentration-time data of Oraxol (paclitaxel and its major metabolites, 3'-p-hydroxy paclitaxel and 6α-hydroxy paclitaxel, and HM30181 methanesulfonate monohydrate and its M1 metabolite)
Measured: Day 1 and 3: Predose, 8 timepoints up to 8 hours postdose; Day 2: Predose; Day 8 and 15: Predose, and between 1 and 3 hours postdose
To characterize the accumulation factor (R) of Oraxol in combination with ramucirumab
Derived by noncompartmental analysis using the plasma concentration-time data of Oraxol (paclitaxel and its major metabolites, 3'-p-hydroxy paclitaxel and 6α-hydroxy paclitaxel, and HM30181 methanesulfonate monohydrate and its M1 metabolite)
Measured: Day 1 and 3: Predose, 8 timepoints up to 8 hours postdose; Day 2: Predose; Day 8 and 15: Predose, and between 1 and 3 hours postdose
To characterize the apparent volume of distribution (Vd/F) of Oraxol in combination with ramucirumab
Derived by noncompartmental analysis using the plasma concentration-time data of Oraxol (paclitaxel and its major metabolites, 3'-p-hydroxy paclitaxel and 6α-hydroxy paclitaxel, and HM30181 methanesulfonate monohydrate and its M1 metabolite)
Measured: Day 1 and 3: Predose, 8 timepoints up to 8 hours postdose; Day 2: Predose; Day 8 and 15: Predose, and between 1 and 3 hours postdose
To characterize the apparent total clearance (CL/F) of Oraxol in combination with ramucirumab
Derived by noncompartmental analysis using the plasma concentration-time data of Oraxol (paclitaxel and its major metabolites, 3'-p-hydroxy paclitaxel and 6α-hydroxy paclitaxel, and HM30181 methanesulfonate monohydrate and its M1 metabolite)
Measured: Day 1 and 3: Predose, 8 timepoints up to 8 hours postdose; Day 2: Predose; Day 8 and 15: Predose, and between 1 and 3 hours postdose
Preliminary activity of Oraxol plus ramucirumab as determined by response rate
Tumor response will be evaluated according to RECIST v1.1 criteria
Measured: Subjects will be evaluated for tumor response per RECIST v1.1 criteria after every 8 weeks (ie, at Weeks 9, 17, 25, etc).
Preliminary activity of Oraxol plus ramucirumab as determined by progression-free survival
Tumor response will be evaluated according to RECIST v1.1 criteria
Measured: Subjects will be evaluated for tumor response per RECIST v1.1 criteria after every 8 weeks (ie, at Weeks 9, 17, 25, etc).
Preliminary activity of Oraxol plus ramucirumab as determined by overall survival
There will be a Follow-up Period during which survival data will be collected
Measured: Investigator,telephone, or family member contact or public records access will be performed every 3 months for the purpose of assessing overall survival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study start8 Dec 2016
- Primary completion27 Mar 2019
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Part 1 of the study will follow the standard "3+3" study design to determine the MTD of Oraxol administered continuously for 3 consecutive days per week (3-day MTD) in combination with ramucirumab. And Part 2 will obtain confirmatory activity, safety, and tolerability data.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
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
- NCT02970539
- Sponsor's protocol ID
- KX-ORAX-005
- Status last verified
- Feb 2021
- First submitted
- 3 Nov 2016
- Last updated
- 16 Feb 2022
- 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 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of Oraxol in Combination With Ramucirumab in Patients With Gastric, Gastro-esophageal, or Esophageal Cancers
- ClinicalTrials.gov ID
- NCT02970539
- Acronym / sponsor ID
- KX-ORAX-005
- Conditions
- Gastric Cancer, Esophageal Cancer, Gastro-esophageal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Athenex, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2016 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 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, single group assignment, safety, tolerability and pharmacokinetic (PK) study to determine the MTD and optimal dosing regimen of Oraxol in combination with ramucirumab.
Detailed description
This is a sequential-group, dose escalation trial to determine the maximum tolerated dose of oral Oraxol in combination with intravenous ramucirumab. After a screening period of up to 28 days subjects will be enrolled into the treatment phase of the study. Each cycle of therapy will last 4 weeks. Subjects may continue in the study until they experience disease progression or unacceptable toxicity. Three to six subjects will be enrolled at each dose level. Once the tolerability of a dose level has been determined, an additional 3-6 subjects may be enrolled at a higher dose level, to determine the maximum tolerated dose. Safety will be monitored through recording of adverse events, serious adverse events, monitoring of laboratory tests including hematology, blood chemistry, urinalyses, physical examinations and electrocardiograms. Subjects will undergo radiographic assessments for tumor response at specified time points. Blood samples will also be obtained in the first cycle of therapy at multiple time points for determination of the amount of paclitaxel and metabolites and HM30181 in the circulation. After the treatment period, there will be a follow-up period during which the subject or family may be contacted every three months for follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Part 1 of the study will follow the standard "3+3" study design to determine the MTD of Oraxol administered continuously for 3 consecutive days per week (3-day MTD) in combination with ramucirumab. And Part 2 will obtain confirmatory activity, safety, and tolerability data.
| Arm | Type | Receives |
|---|---|---|
| Oraxol +Ramucirumab | Experimental | Drug: Oraxol, Drug: RamucirumabOraxol (oral HM30181 + oral paclitaxel) * HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets * Paclitaxel - supplied as 30-mg capsules Ramucirumab - supplied as a solution at a concentration of 10 mg/mL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects must meet all of the following criteria to be included in this study:
- 1. Signed written informed consent 2. ≥18 years of age 3. Histologically or cytologically confirmed diagnosis of advanced stage gastric, gastro-esophageal (Part 1 or Part 2), or esophageal adenocarcinoma (Part 1 only) with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy 4. Have documented testing for HER2-neu overexpression, and for those with tumors overexpressing HER2-neu, have documented progression on Trastuzumab-containing therapy 5. Measurable disease on computed tomography (CT) scan of thorax, abdomen, and pelvis, per RECIST v1.1 criteria 6. Able to swallow oral medication as an intact dosage form 7. Adequate hematologic status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain:
- 10. Normal prothrombin time (PT) or international normalized ratio (INR) and normal activated partial thromboplastin time (aPTT) unless subject is on anticoagulation therapy 11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 12. Life expectancy of at least 3 months 13. 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.
- 14. 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.
Key exclusion criteria (25 listed)
- Unresolved toxicity from previous anticancer treatments, including investigational products (subjects must have recovered all unacceptable toxicity to ≤ Grade 1 Common Terminology Criteria for Adverse Events [CTCAE] toxicity). This does not extend to symptoms or findings that are attributable to the underlying disease.
- Received investigational products within 14 days or 5 half-lives of the first study dosing day, whichever is longer; subjects receiving biologic agents (eg, monoclonal antibodies) require a 30-day washout period.
- Are currently receiving other medications or radiation intended for the treatment of their malignancy
- Central nervous system metastases, including leptomeningeal involvement
- Women of childbearing potential who are pregnant or breastfeeding
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: oral HM30181AK-US tablet and paclitaxel capsuleOraxol (Paclitaxel and HM30181A) will be dosed orally. Paclitaxel will be supplied as capsules and HM30181A will be supplied as tablets. | Drug | Oraxol +Ramucirumab |
| RamucirumabAlso: LY3009806Ramucirumab will be administered by iv infusion and supplied as a solution at a concentration of 10 mg/mL | Drug | Oraxol +Ramucirumab |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: The first 4 weeks
The primary endpoint of determining the MTD will be based on DLT
13 secondary outcomes
To determine the safety and tolerability of Oraxol in combination with ramucirumab
Time frame: through study completion
The recommended Phase 2 dose of Oraxol in combination with ramucirumab
Time frame: One month
To characterize the area under the blood concentration curve (AUCt) of Oraxol in combination with ramucirumab
Time frame: Day 1 and 3: Predose, 8 timepoints up to 8 hours postdose; Day 2: Predose; Day 8 and 15: Predose, and between 1 and 3 hours postdose
To characterize the area under the plasma concentration-time curve from 0 to 8 hours (AUC0-8h) of Oraxol in combination with ramucirumab
Time frame: Day 1 and 3: Predose, 8 timepoints up to 8 hours postdose; Day 2: Predose; Day 8 and 15: Predose, and between 1 and 3 hours postdose
To characterize the maximum observed plasma concentration (Cmax) of Oraxol in combination with ramucirumab
Time frame: Day 1 and 3: Predose, 8 timepoints up to 8 hours postdose; Day 2: Predose; Day 8 and 15: Predose, and between 1 and 3 hours postdose
To characterize the minimum observed plasma concentration (Cmin) of Oraxol in combination with ramucirumab
Time frame: Day 1 and 3: Predose, 8 timepoints up to 8 hours postdose; Day 2: Predose; Day 8 and 15: Predose, and between 1 and 3 hours postdose
To characterize the plasma half-life (t1/2) of Oraxol in combination with ramucirumab
Time frame: Day 1 and 3: Predose, 8 timepoints up to 8 hours postdose; Day 2: Predose; Day 8 and 15: Predose, and between 1 and 3 hours postdose
To characterize the accumulation factor (R) of Oraxol in combination with ramucirumab
Time frame: Day 1 and 3: Predose, 8 timepoints up to 8 hours postdose; Day 2: Predose; Day 8 and 15: Predose, and between 1 and 3 hours postdose
To characterize the apparent volume of distribution (Vd/F) of Oraxol in combination with ramucirumab
Time frame: Day 1 and 3: Predose, 8 timepoints up to 8 hours postdose; Day 2: Predose; Day 8 and 15: Predose, and between 1 and 3 hours postdose
To characterize the apparent total clearance (CL/F) of Oraxol in combination with ramucirumab
Time frame: Day 1 and 3: Predose, 8 timepoints up to 8 hours postdose; Day 2: Predose; Day 8 and 15: Predose, and between 1 and 3 hours postdose
Preliminary activity of Oraxol plus ramucirumab as determined by response rate
Time frame: Subjects will be evaluated for tumor response per RECIST v1.1 criteria after every 8 weeks (ie, at Weeks 9, 17, 25, etc).
Preliminary activity of Oraxol plus ramucirumab as determined by progression-free survival
Time frame: Subjects will be evaluated for tumor response per RECIST v1.1 criteria after every 8 weeks (ie, at Weeks 9, 17, 25, etc).
Preliminary activity of Oraxol plus ramucirumab as determined by overall survival
Time frame: Investigator,telephone, or family member contact or public records access will be performed every 3 months for the purpose of assessing overall survival.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- 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.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oraxol and Ramucirumab in people with Gastric Cancer and Esophageal Cancer, run by Athenex, Inc. at 5 sites in 2 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 13 inclusion and 25 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 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan, 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?
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) (time frame: The first 4 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 16 Feb 2022.