Phase 2
Completed N=34
A Confirmation Study of Eribulin in Combination With Capecitabine
Source: ClinicalTrials.gov NCT01323530 ↗Enrolled (actual)
34
Serious AEs
34.2%
Results posted
Jan 2021
Primary outcomePrimary: Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) — 1; 1; 2; 0 Participants
Summary
This is a Phase 1b/2, multi-center, open-label, dose escalation (in 2 different dosing schedules [1 and 2]) and dose-confirmation study of eribulin administered in combination with capecitabine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) |
1; 1; 2; 0; 1; 1 | — |
| PRIMARY Phase 2: Objective Response Rate (ORR) |
42.9 | — |
| SECONDARY Phase 2: Time to Response |
44.0 | — |
| SECONDARY Phase 2: Duration of Response (DOR) |
261.0 | — |
| SECONDARY Phase 2: Stable Disease (SD) Rate |
38.1 | — |
| SECONDARY Phase 1b and Phase 2: Percentage of Participants With Non-CR/Non-PD |
0; 0; 0; 0; 16.7; 0 | — |
| SECONDARY Phase 2: Duration of Stable Disease (SD) |
162.0 | — |
| SECONDARY Phase 2: Disease Control Rate (DCR) |
81.0 | — |
| SECONDARY Phase 2: Clinical Benefit Rate (CBR) |
57.1 | — |
| SECONDARY Phase 2: Progression-free Survival (PFS) |
219.0 | — |
Eligibility Criteria
Inclusion Criteria
Subjects who meet all of the following criteria will be included in the study:
Dose-escalation cohorts (Phase 1b):
- Histologically or cytologically confirmed cancer that is advanced and/or metastatic
- Resistant/refractory to approved therapies (defined as progressive disease during or within 6 months after the last anti-cancer therapy) or for whom single agent capecitabine at this dose level and schedule would be a reasonable treatment option in the opinion of the investigator
- For subjects that previously received capecitabine, all capecitabine related toxicities must have completely resolved
- Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L, hemoglobin greater than or equal to 10.0 g/dL (this may have been corrected by growth factor or transfusion), and platelet count greater than or equal to 100 x 10^9/L
- Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) and alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 x ULN (in the case of liver metastases less than or equal to 5 x ULN). In case AP is greater than 3 x ULN (in absence of liver metastases) or greater than 5 x ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP.
- Adequate renal function as evidenced by calculated creatinine clearance greater than or equal to 50 mL/min as per the Cockcroft-Gault formula (Appendix 1) or radioisotope measurement.
- Females of childbearing potential must have a negative urine or serum beta human chorionic gonadotropin (hCG) at Visit 1 (Screening) and prior to starting study drugs on Day 1. Female subjects of childbearing potential must agree to be abstinent or to use highly effective methods of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, intrauterine device (IUD), or have a vasectomized partner) having starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of nonchildbearing potential.
- Male subjects who are not abstinent or have not undergone a successful vasectomy, who are partners of women of childbearing potential must use, or their partners must use, a highly affective method of contraception (e.g. condom + spermicide, condom + diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously)
- Life expectancy of greater than 3 months
- Willing and able to comply with all aspects of the protocol
- Provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal to 2
- Males and females, age greater than or equal to18 years
Dose-confirmation cohorts (Phase 2):
- Histologically or cytologically confirmed carcinoma of the breast that is advanced and/or metastatic
- Received up to three prior chemotherapy regimens in any setting (sequential neoadjuvant/ adjuvant treatment counting as one regimen)
- Chemotherapy regimens must have included an anthracycline (unless anthracycline containing chemotherapy is inappropriate) and a taxane, either in combination or in separate regimens
- No prior treatment with capecitabine in any
Data sourced from ClinicalTrials.gov (NCT01323530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.