Gastric CancerPhase 1/2NCT03707028
A Study to Evaluate Safety, Tolerability, and Efficacy Profile of Rivoceranib With Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer
A Phase 1/2 study testing Rivoceranib and Paclitaxel in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Elevar Therapeutics at 1 site in South Korea.
Trial summary
This is an open-label, single-center, single-arm, dose escalation and dose expansion Phase I/IIa study designed to determine the recommended Phase 2 dose (RP2D) and the safety and tolerability profile along with preliminary signs of efficacy of rivoceranib in combination with paclitaxel as a second-line therapy in… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Rivoceranib and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2018to 24 Aug 2021
- Phase
- Phase 1/2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with documented locally advanced unresectable or metastatic gastric or gastroesophageal junction cancer refractory to or relapsing after first line platinum and fluoropyrimidine containing chemotherapy (with or without trastuzumab) with an indication for therapy with paclitaxel and an antiangiogenic agent. If disease progression occurs during or within 6 months after completion of any adjuvant chemotherapy, this therapy is considered a first-line chemotherapy for participant eligibility.
- Participants who have provided tumor tissue prior to initiation of first-line therapy and have provided or can provide tumor tissue prior to screening in this study. This will be optional for Phase I participants. Tumor tissue must not have been irradiated.
- Participants who have at least 1 measurable lesion as defined by RECIST v1.1. This will be optional for Phase I participants.
- Adequate bone marrow, renal, and liver function evidenced by:
- Hematologic: Absolute neutrophil count of ≥1,500/cubic millimeter (mm^3), platelet count of ≥ 1,00,000/mm ^3, and hemoglobin of ≥9.0 grams (g)/deciliter (dL). Transfusion of platelets or red blood cells to meet the inclusion criteria within 2 weeks of screening is not allowed.
- Adequate renal function, defined as meeting any 1 of the following criteria:
Show all 14Show fewer
- Serum creatinine <1.5 × upper limit of normal (ULN). ii. Creatinine clearance based on the Cockcroft-Gault estimate ≥50 milliliters per minute (mL/min) or creatinine clearance based on urine collection (12 or 24 hours) ≥50 mL/min.
- In addition, urinary protein should be <2+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria ≥2+, then a 24 hour urine or urine protein/creatinine ratio must be collected and must demonstrate <2 g of protein in 24 hours.
- Hepatic: Serum bilirubin <1.5 × ULN, aspartate and alanine aminotransferase ≤3.0 × ULN (≤5.0 × UNL, if with liver metastases). If liver and/or bone metastases alkaline phosphatase ≤5 × ULN.
- Blood coagulation tests: Prothrombin time and international normalized ratio ≤1.5 × ULN.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Estimated life expectancy of at least 12 weeks.
- Ability to swallow the study drug without chewing, breaking, crushing, opening or otherwise altering the product formulation. If vomiting occurs, the dose will not be replaced. Antiemetics must be used at efficacious doses.
- No major gastrointestinal disease (e.g., chronic diarrheal disease) or intestinal surgery that can jeopardize drug absorption.
Who cannot join
- Prior use of taxane (paclitaxel or docetaxel) or any contraindication for therapy with paclitaxel.
- Previous treatment with rivoceranib or any other systemic therapy with a vascular endothelial growth factor (VEGF) pathway inhibitor.
- Known hypersensitivity to rivoceranib or any component of its formulation or history of severe adverse events, including uncontrolled hypertension or other common anti-angiogenesis drug class effects during prior exposure to vascular inhibitors.
- Any unresolved toxicity Grade >1 (except alopecia) from previous anticancer therapy (including radiotherapy).
- Has history of another malignancy within 2 years prior to screening. Participants with the following are eligible for this study if, in the opinion of the investigator, they do not pose a significant risk to life expectancy:
- Bladder tumors considered superficial such as noninvasive (T1a) and carcinoma in situ (Tis).
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- Curatively treated cervical carcinoma in situ.
- Thyroid papillary cancer with prior treatment.
- Carcinoma of the skin without melanomatous features.
- Prostate cancer which has been surgically or medically treated and not likely to recur within 2 years.
- Known brain metastasis or other central nervous system metastasis that is either symptomatic or untreated. Metastases that have been treated by complete resection and/or radiotherapy demonstrating stability or improvement are not an exclusion criterion provided they are stable as shown by computed tomographic scan at least 4 weeks before screening without evidence of cerebral edema. Participants on stable dose of corticosteroids or anticonvulsants are permitted.
- Has received prior anticancer therapy within 3 weeks before Cycle 1 Day 1. Traditional herbal remedies with anti-infective, immune stimulating, or anticancer properties are not allowed from screening throughout the entire period of study participation.
- Current or recent (within 10 days of Cycle 1 Day 1) use of full dose oral or parenteral anticoagulants or other thrombolytic agents for therapeutic (as opposed to prophylactic) purposes, clinically serious non-healing wounds, or incompletely healed bone fracture. A maximum dose of 325 milligrams (mg)/day of aspirin is allowed.
- Participants who had therapeutic paracentesis of ascites (>1 liter [L]) within the 2 months prior to starting study treatment or who, in the opinion of the investigator, will likely need therapeutic paracentesis of ascites (>1L) within 2 months of Cycle 1 Day 1.
- Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9, and CYP2C19.
- Active bacterial infections (including tuberculosis and syphilis) requiring systemic antibiotic therapy.
- Known history of human immunodeficiency virus infection.
- Active hepatitis B or C infection or chronic hepatitis B or C infection requiring treatment with antiviral therapy or prophylactic antiviral therapy; unless evidence of viral suppression has been documented and the participant will remain on appropriate antiviral therapy throughout the study.
- Child-Pugh Stage B and C liver function impairment.
- Pregnant or breastfeeding women. Participants unwilling to comply with birth control requirements will not be eligible.
- History of uncontrolled hypertension (blood pressure ≥140/90 mmHg and change in antihypertensive medication within 7 days prior to screening) that is not well managed by medication and the risk of which may be precipitated by a VEGF inhibitor therapy. History of hypertensive crisis, and hypertensive encephalopathy.
- Participants who have a known history of symptomatic congestive heart failure (New York Heart Association III to IV), symptomatic or poorly controlled cardiac arrhythmia, complete left bundle branch block, bifascicular block, or any clinically significant ST segment and/or T wave abnormalities, corrected QT interval by Fredericia (QTcF) > 450 msec for males or QTcF > 470 milliseconds (msec) for females prior to screening.
- History of bleeding diathesis or clinically significant bleeding within 14 days prior to Cycle 1 Day 1. This includes a history of gastrointestinal bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3 months prior to Cycle 1 Day 1 that, in the investigator's opinion, may place the participant at risk of side effects from anti-angiogenesis products.
- History of clinically significant thrombosis (bleeding or clotting disorder) within the past 3 months prior to Cycle 1 Day 1 that, in the investigator's opinion, may place the participant at risk of side effects from anti-angiogenesis products.
- History of other significant cardiovascular diseases or vascular diseases within the last 6 months prior to screening (e.g., myocardial infarction or unstable angina pectoris, stroke or transient ischemic attack, or significant peripheral vascular diseases) that, in the investigator's opinion, may pose a risk to the participant on vascular endothelial growth factor receptors (VEGFR) inhibitor therapy.
- History of clinically significant glomerulonephritis, biopsy-proven tubulointerstitial nephritis, crystal nephropathy, or other renal insufficiencies.
- Psychological, familial, sociological, or geographical conditions including drug or alcohol abuse that do not permit compliance with the study participation or evaluation of the study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/IIa Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Rivoceranib in Combination With Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer
This is an open-label, single-center, single-arm, dose escalation and dose expansion Phase I/IIa study designed to determine the recommended Phase 2 dose (RP2D) and the safety and tolerability profile along with preliminary signs of efficacy of rivoceranib in combination with paclitaxel as a second-line therapy in advanced, recurrent and/or metastatic gastric or gastroesophageal junction cancer. This study will also characterize the pharmacokinetic (PK) parameters of rivoceranib and paclitaxel when given in combination.
Read the detailed description
Primary Phase I Objectives
- To determine the RP2D dose of rivoceranib in combination with paclitaxel.
Primary Phase II Objectives
- To determine clinical activity of the combination of rivoceranib and paclitaxel.
Secondary Phase I Objectives
- To evaluate the PK of rivoceranib and paclitaxel when given in combination.
- To assess the efficacy of rivoceranib in combination with paclitaxel.
Secondary Phase II Objectives
- To assess the efficacy of rivoceranib in combination with paclitaxel.
- To assess the safety and tolerability of rivoceranib in combination with paclitaxel.
- To assess the PK of rivoceranib and paclitaxel when given in combination.
- Being tested
- Rivoceranib, Paclitaxel
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivoceranibDrug
Also called Apatinib
Film-coated tablet
PaclitaxelDrug
Also called Taxol
Solution administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Rivoceranib with Paclitaxel | Experimental | Participants will receive oral daily doses of rivoceranib per 28-day cycle (as its mesylate salt) with a fixed dose of paclitaxel given intravenously on Day 1, Day 8, and Day 15 of the 28-day cycle. Receives: Drug: Rivoceranib; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Incidence of Dose-Limiting Toxicities (DLT) During Cycle 1
The number and proportion of participants experiencing DLTs will be reported by dose level, based on DLT observations during Cycle 1. Each Cycle is 28 days.
Measured: Cycle 1 (first 28 days)
Phase I: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs)
An AE is any untoward medical occurrence in a participant or participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent 1 of the other outcomes listed above.
Measured: Up to 24 months
Phase II: Objective Response Rate (ORR)
ORR is the percentage of participants who achieve objective tumor response (complete response [CR] or partial response [PR]) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for response.
Measured: Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months
Secondary outcomes (19)
Phase I: Maximum Observed Concentration (Cmax)
Measured: Day 1 & 15 of Cycle 1 (each cycle is 28 days)
Phase I: Time to Maximum Observed Concentration (tmax)
Measured: Day 1 & 15 of Cycle 1 (each cycle is 28 days)
Phase I: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-t)
Measured: Day 1 & 15 of Cycle 1 (each cycle is 28 days)
Phase I: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞)
Measured: Day 1 & 15 of Cycle 1 (each cycle is 28 days)
Phase I: Terminal Half-life (t1/2)
Measured: Day 1 & 15 of Cycle 1 (each cycle is 28 days)
Phase I: Apparent Oral Plasma Clearance (CL/F)
Measured: Day 1 & 15 of Cycle 1 (each cycle is 28 days)
Phase I: Apparent Volume of Distribution (Vz/F)
Measured: Day 1 & 15 of Cycle 1 (each cycle is 28 days)
Phase I: Terminal Rate Constant (λz)
Measured: Day 1 & 15 of Cycle 1 (each cycle is 28 days)
Phase I: ORR
ORR by RECIST 1.1
Measured: Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months
Phase I: Progression-free Survival (PFS)
Defined as time from first dose of study drug (Cycle 1 Day 1) to the time of first documented disease progression or death due to any cause.
Measured: Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months
Phase I: Overall survival (OS)
OS is the time from first dose of study drug (Cycle 1 Day 1) to the time of death from any cause.
Measured: Ongoing assessment from enrollment until end of study, up to approximately 24 months
Phase I: Disease Control Rate (DCR)
DCR is defined as the percentage of participants who achieve CR or PR and stable disease (SD) at ≥12 weeks.
Measured: Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months
Phase I: Duration of Response
Defined as the time from first documentation of (complete response or partial response) to the first documentation of progression.
Measured: Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months
Phase II: PFS
Defined as time from first dose of study drug (Cycle 1 Day 1) to the time of first documented disease progression or death due to any cause.
Measured: Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months
Phase II: OS
OS is the time from first dose of study drug (Cycle 1 Day 1) to the time of death from any cause.
Measured: Ongoing assessment from enrollment until end of study, up to approximately 24 months
Phase II: DCR
DCR is defined as the percentage of participants who achieve CR or PR and SD at ≥12 weeks.
Measured: Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months
Phase II: Duration of Response
Defined as the time from first documentation of (complete response or partial response) to the first documentation of progression.
Measured: Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months
Phase II: Number of Participants With AEs and SAEs
Adverse Events and Serious Adverse Events
Measured: Ongoing assessment from enrollment until end of study, approximately 24 months
Phase II: Concentration at the End of the Dosage Interval (Ctrough)
Ctrough is characterized at steady state after single and multiple cycles of treatment.
Measured: Ongoing assessment from enrollment until end of study, approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start1 Oct 2018
- Primary completion24 Aug 2021
- Study completion24 Aug 2021
Why it stopped: Terminated after completion of Part 1 due to a change in research plan.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elevar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-Hee Ryu, Dr., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707028
- Sponsor's protocol ID
- LSK-RM109
- Status last verified
- Apr 2022
- First submitted
- 8 Oct 2018
- Last updated
- 11 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Rivoceranib in Combination With Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer
- ClinicalTrials.gov ID
- NCT03707028
- Acronym / sponsor ID
- LSK-RM109
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated after completion of Part 1 due to a change in research plan.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Elevar TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 24 Aug 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 16 Oct 2018 (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 an open-label, single-center, single-arm, dose escalation and dose expansion Phase I/IIa study designed to determine the recommended Phase 2 dose (RP2D) and the safety and tolerability profile along with preliminary signs of efficacy of rivoceranib in combination with paclitaxel as a second-line therapy in advanced, recurrent and/or metastatic gastric or gastroesophageal junction cancer. This study will also characterize the pharmacokinetic (PK) parameters of rivoceranib and paclitaxel when given in combination.
Detailed description
Primary Phase I Objectives
- To determine the RP2D dose of rivoceranib in combination with paclitaxel.
Primary Phase II Objectives
- To determine clinical activity of the combination of rivoceranib and paclitaxel.
Secondary Phase I Objectives
- To evaluate the PK of rivoceranib and paclitaxel when given in combination.
- To assess the efficacy of rivoceranib in combination with paclitaxel.
Secondary Phase II Objectives
- To assess the efficacy of rivoceranib in combination with paclitaxel.
- To assess the safety and tolerability of rivoceranib in combination with paclitaxel.
- To assess the PK of rivoceranib and paclitaxel when given in combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivoceranib with Paclitaxel | Experimental | Drug: Rivoceranib, Drug: PaclitaxelParticipants will receive oral daily doses of rivoceranib per 28-day cycle (as its mesylate salt) with a fixed dose of paclitaxel given intravenously on Day 1, Day 8, and Day 15 of the 28-day cycle. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participants with documented locally advanced unresectable or metastatic gastric or gastroesophageal junction cancer refractory to or relapsing after first line platinum and fluoropyrimidine containing chemotherapy (with or without trastuzumab) with an indication for therapy with paclitaxel and an antiangiogenic agent. If disease progression occurs during or within 6 months after completion of any adjuvant chemotherapy, this therapy is considered a first-line chemotherapy for participant eligibility.
- Participants who have provided tumor tissue prior to initiation of first-line therapy and have provided or can provide tumor tissue prior to screening in this study. This will be optional for Phase I participants. Tumor tissue must not have been irradiated.
- Participants who have at least 1 measurable lesion as defined by RECIST v1.1. This will be optional for Phase I participants.
- Adequate bone marrow, renal, and liver function evidenced by:
- Blood coagulation tests: Prothrombin time and international normalized ratio ≤1.5 × ULN.
Key exclusion criteria (27 listed)
- Prior use of taxane (paclitaxel or docetaxel) or any contraindication for therapy with paclitaxel.
- Previous treatment with rivoceranib or any other systemic therapy with a vascular endothelial growth factor (VEGF) pathway inhibitor.
- Known hypersensitivity to rivoceranib or any component of its formulation or history of severe adverse events, including uncontrolled hypertension or other common anti-angiogenesis drug class effects during prior exposure to vascular inhibitors.
- Any unresolved toxicity Grade >1 (except alopecia) from previous anticancer therapy (including radiotherapy).
- Has history of another malignancy within 2 years prior to screening. Participants with the following are eligible for this study if, in the opinion of the investigator, they do not pose a significant risk to life expectancy:
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 |
|---|---|---|
| RivoceranibAlso: ApatinibFilm-coated tablet | Drug | Rivoceranib with Paclitaxel |
| PaclitaxelAlso: TaxolSolution administered intravenously | Drug | Rivoceranib with Paclitaxel |
Primary outcome
Phase I: Incidence of Dose-Limiting Toxicities (DLT) During Cycle 1
Time frame: Cycle 1 (first 28 days)
The number and proportion of participants experiencing DLTs will be reported by dose level, based on DLT observations during Cycle 1. Each Cycle is 28 days.
Phase I: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: Up to 24 months
An AE is any untoward medical occurrence in a participant or participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent 1 of the other outcomes listed above.
Phase II: Objective Response Rate (ORR)
Time frame: Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months
ORR is the percentage of participants who achieve objective tumor response (complete response [CR] or partial response [PR]) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for response.
19 secondary outcomes
Phase I: Maximum Observed Concentration (Cmax)
Time frame: Day 1 & 15 of Cycle 1 (each cycle is 28 days)
Phase I: Time to Maximum Observed Concentration (tmax)
Time frame: Day 1 & 15 of Cycle 1 (each cycle is 28 days)
Phase I: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-t)
Time frame: Day 1 & 15 of Cycle 1 (each cycle is 28 days)
Phase I: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Day 1 & 15 of Cycle 1 (each cycle is 28 days)
Phase I: Terminal Half-life (t1/2)
Time frame: Day 1 & 15 of Cycle 1 (each cycle is 28 days)
Phase I: Apparent Oral Plasma Clearance (CL/F)
Time frame: Day 1 & 15 of Cycle 1 (each cycle is 28 days)
Phase I: Apparent Volume of Distribution (Vz/F)
Time frame: Day 1 & 15 of Cycle 1 (each cycle is 28 days)
Phase I: Terminal Rate Constant (λz)
Time frame: Day 1 & 15 of Cycle 1 (each cycle is 28 days)
Phase I: ORR
Time frame: Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months
Phase I: Progression-free Survival (PFS)
Time frame: Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months
Phase I: Overall survival (OS)
Time frame: Ongoing assessment from enrollment until end of study, up to approximately 24 months
Phase I: Disease Control Rate (DCR)
Time frame: Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months
Phase I: Duration of Response
Time frame: Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months
Phase II: PFS
Time frame: Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months
Phase II: OS
Time frame: Ongoing assessment from enrollment until end of study, up to approximately 24 months
Phase II: DCR
Time frame: Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months
Phase II: Duration of Response
Time frame: Every other cycle (each cycle is 28 days) until end of study, assessed up to 24 months
Phase II: Number of Participants With AEs and SAEs
Time frame: Ongoing assessment from enrollment until end of study, approximately 24 months
Phase II: Concentration at the End of the Dosage Interval (Ctrough)
Time frame: Ongoing assessment from enrollment until end of study, approximately 24 months
Results and safety
The study was stopped early (reason given: Terminated after completion of Part 1 due to a change in research plan.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
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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-Hee Ryu, Dr. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rivoceranib and Paclitaxel in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Elevar Therapeutics at 1 site in South Korea.
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 27 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: stopped early, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Terminated after completion of Part 1 due to a change in research plan.). 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?
Phase I: Incidence of Dose-Limiting Toxicities (DLT) During Cycle 1 (time frame: Cycle 1 (first 28 days)). The study lists 3 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 11 Apr 2022.