A Phase 2 interventional study of nab-paclitaxel and ramucirumab in Gastroesophageal Cancer, sponsored by SCRI Development Innovations, LLC. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-01.
Sponsored by SCRI Development Innovations, LLC · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether nab-Paclitaxel (Abraxane®) and ramucirumab (Cyramza®) are effective when used in combination for treating patients with metastatic gastroesophageal cancer who have either progressed or not responded to prior therapy.
Adenocarcinoma of the esophagus and the gastroesophageal junction (GE junction) is the ninth most common cancer worldwide. Ramucirumab (Cyramza®), a monoclonal antibody, is approved as a single agent and in combination with paclitaxel as a treatment for patients with metastatic gastric or GE junction adenocarcinoma whose cancer has progressed after prior chemotherapy. Nab-paclitaxel (Abraxane®) is an albumin-based formulation of paclitaxel which was developed to improve the therapeutic index and reduce toxicity. Nab-paclitaxel is approved in over 40 countries/regions for treatment of various metastatic cancers including breast cancer, non-small cell lung cancer (NSCLC), and pancreatic cancer. In this Phase II study, the investigators propose to combine the less toxic nab-paclitaxel to increase tumor uptake of the drug and improve efficacy while minimizing side effects. The biological rationale of using this combination is that ramucirumab will inhibit tumor angiogenesis and nab-paclitaxel will induce apoptosis of the rapidly dividing tumor cell.
SCRI Development Innovations, LLC is the lead sponsor of 174 studies on the registry; 5 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients will receive 125 mg/m\^2 of nab-Paclitaxel intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle (weekly for 3 weeks, with 1 week of rest). Patients will receive ramucirumab 8mg/kg IV in combination with nab-paclitaxel on Days 1 and 15 of the 28-day cycle.
Drug: nab-paclitaxel · Biological: ramucirumab
nab-paclitaxel 125 mg/m\^2 IV
Also known as: Abraxane, ABI-007
Ramucirumab 8 mg/kg IV
Also known as: Cyramza, IMC-1121B
Progression-Free Survival (PFS)
Measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation in Solid Tumors Criteria (RECIST v1.1), or death on study from any cause. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Participants who are alive and free from disease progression were censored at the date of the last adequate tumor assessment. If no adequate post-treatment tumor assessments were obtained for participants, PFS will be censored on Day 1.
Time frame: up to 1 year
Overall Response Rate (ORR)
ORR is defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR), i.e., two CRs and/or PRs at least 4 weeks apart, according to the RECIST v1.1 criteria. CR=disappearance of all target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: every 8 weeks up to 1 year
Time to Progression (TTP)
TTP is defined as the time from the first day of study drug administration (Day 1) to objective disease progression as defined by the RECIST v1.1 criteria. Patients who are alive and free from disease progression will be censored at the date of the last adequate tumor assessment. If no adequate post-treatment tumor assessments were obtained for a patient, TTP will be censored on Day 1. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or unequivocal progression of non-target lesions or the appearance of one or more new lesions.
Time frame: up to 1 year
Overall Survival (OS)
OS is defined as the time from the first treatment until date of death due to any cause. In the absence of confirmation of death or lack of data beyond follow-up period, the survival time was censored to last date the participant was known to be alive.
Time frame: up to 1 year
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Adverse events will be graded utilizing the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
Time frame: For duration of treatment, up to of 6 months
| Milestone | Nab-paclitaxel and Ramucirumab |
|---|---|
| Started | 65 |
| Completed | 0 |
| Not completed | 65 |
| Withdrew: Adverse event | 12 |
| Withdrew: Death | 4 |
| Withdrew: Withdrawal by subject | 8 |
| Withdrew: Progressive disease | 41 |
Measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation in Solid Tumors Criteria (RECIST v1.1), or death on study from any cause. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Participants who are alive and free from disease progression were censored at the date of the last adequate tumor assessment. If no adequate post-treatment tumor assessments were obtained for participants, PFS will be censored on Day 1.
| months | Nab-paclitaxel and Ramucirumab |
|---|---|
| Progression-Free Survival (PFS) | 3.8 (3.4 to 5.7) |
ORR is defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR), i.e., two CRs and/or PRs at least 4 weeks apart, according to the RECIST v1.1 criteria. CR=disappearance of all target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
| percentage of participants | Nab-paclitaxel and Ramucirumab |
|---|---|
| Overall Response Rate (ORR) | 20 (10.3 to 29.7) |
TTP is defined as the time from the first day of study drug administration (Day 1) to objective disease progression as defined by the RECIST v1.1 criteria. Patients who are alive and free from disease progression will be censored at the date of the last adequate tumor assessment. If no adequate post-treatment tumor assessments were obtained for a patient, TTP will be censored on Day 1. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or unequivocal progression of non-target lesions or the appearance of one or more new lesions.
| months | Nab-paclitaxel and Ramucirumab |
|---|---|
| Time to Progression (TTP) | 4.5 (3.5 to 6.4) |
OS is defined as the time from the first treatment until date of death due to any cause. In the absence of confirmation of death or lack of data beyond follow-up period, the survival time was censored to last date the participant was known to be alive.
| months | Nab-paclitaxel and Ramucirumab |
|---|---|
| Overall Survival (OS) | 8 (6.4 to 10.5) |
Adverse events will be graded utilizing the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
| Participants | Nab-paclitaxel and Ramucirumab |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability | 62 |
Collected over For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nab-paclitaxel and Ramucirumab | 51/65 (78.5%) | 30/65 (46.2%) | 62/65 (95.4%) |
| Event | Nab-paclitaxel and Ramucirumab |
|---|---|
| PneumoniaInfections and infestations | 6/65 |
| SepsisInfections and infestations | 5/65 |
| Febrile neutropeniaBlood and lymphatic system disorders | 3/65 |
| Septic shockInfections and infestations | 3/65 |
| DysphagiaGastrointestinal disorders | 2/65 |
| NauseaGastrointestinal disorders | 2/65 |
| Upper gastrointestinal haemorrhageGastrointestinal disorders | 2/65 |
| VomitingGastrointestinal disorders | 2/65 |
| AnaemiaBlood and lymphatic system disorders | 1/65 |
| Iron deficiency anaemiaBlood and lymphatic system disorders | 1/65 |
| Event | Nab-paclitaxel and Ramucirumab |
|---|---|
| NeutropeniaBlood and lymphatic system disorders | 29/65 |
| FatigueGeneral disorders | 29/65 |
| Decreased appetiteMetabolism and nutrition disorders | 24/65 |
| NauseaGastrointestinal disorders | 17/65 |
| Weight decreasedInvestigations | 16/65 |
| AlopeciaSkin and subcutaneous tissue disorders | 16/65 |
| Neuropathy peripheralNervous system disorders | 15/65 |
| Oedema peripheralGeneral disorders | 14/65 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 14/65 |
| Abdominal painGastrointestinal disorders | 13/65 |
| Age, Continuous(years) | Nab-paclitaxel and Ramucirumab |
|---|---|
| Median | 63 (35 to 86) |
| Sex: Female, Male(Participants) | Nab-paclitaxel and Ramucirumab |
|---|---|
| Female | 16 |
| Male | 49 |
| Race (NIH/OMB)(Participants) | Nab-paclitaxel and Ramucirumab |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 58 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Nab-paclitaxel and Ramucirumab |
|---|---|
| United States | 65 |
| Participants with HER2 positive status (confirmed by FISH)(Participants) | Nab-paclitaxel and Ramucirumab |
|---|---|
| Count of participants | 12 |
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SCRI Development Innovations, LLC