A Phase 2 interventional study of Leucovorin and Fluorouracil - bolus in Cancer, sponsored by AbbVie. Terminated at 65 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-09.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
A study to evaluate the efficacy and tolerability of ABT-165 plus FOLFIRI compared to bevacizumab plus FOLFIRI in participants with previously treated metastatic adenocarcinoma of the colon or rectum.
Diagnosis of histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
Exclusion Criteria:
ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Drug: Leucovorin · Drug: Fluorouracil - bolus · Drug: Fluorouracil - infusion · Drug: ABT-165 · Drug: Irinotecan
Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Drug: Leucovorin · Drug: Fluorouracil - bolus · Drug: Bevacizumab · Drug: Fluorouracil - infusion · Drug: Irinotecan
Intravenous
Also known as: Folinic Acid
Intravenous
Also known as: 5-FU
Intravenous
Also known as: Avastin
Intravenous
Also known as: 5-FU
Intravenous
Intravenous
Also known as: Irinotecan hydrochloride
Progression Free Survival (PFS)
PFS is defined as the time from randomization until the first occurrence of radiographic progression determined by investigator assessment or death from any cause.
Time frame: Follow up continued until the first occurrence of radiographic progression, death from any cause or termination of the study; median follow-up time was 25.6(0.3-64.4) and 37.6(0.3-66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab + FOLFIRI, respectively
Objective Response Rate (ORR)
ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) as determined by a investigator assessment based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
Time frame: From randomization up to 30 days after last dose of study drug; median time on follow-up was 25.6 (0.3 - 64.4) and 37.6 (0.3 - 66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab plus FOLFIRI, respectively
Overall Survival (OS)
OS is defined as the time from randomization until death from any cause.
Time frame: Follow up continued until the first occurrence of radiographic progression, death from any cause or termination of the study; median follow-up time was 25.6(0.3-64.4) and 37.6(0.3-66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab + FOLFIRI, respectively
The intent to treat (ITT) population included all randomized participants and was used for all efficacy and baseline analyses.
| Milestone | ABT-165 Plus FOLFIRI | Bevacizumab Plus FOLFIRI |
|---|---|---|
| Started | 36 | 34 |
| Completed | 0 | 0 |
| Not completed | 36 | 34 |
| Withdrew: Withdrew consent | 5 | 4 |
| Withdrew: Death | 12 | 6 |
| Withdrew: Study terminated by sponsor | 18 | 23 |
| Withdrew: Other | 1 | 1 |
PFS is defined as the time from randomization until the first occurrence of radiographic progression determined by investigator assessment or death from any cause.
| Months | ABT-165 Plus FOLFIRI | Bevacizumab Plus FOLFIRI |
|---|---|---|
| Progression Free Survival (PFS) | 3.78 (2.07 to 7.20) | 7.36 (5.68 to 10.55) |
ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) as determined by a investigator assessment based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
| percentage of participants | ABT-165 Plus FOLFIRI | Bevacizumab Plus FOLFIRI |
|---|---|---|
| Objective Response Rate (ORR) | 5.6 (0.7 to 18.7) | 14.7 (5.0 to 31.1) |
OS is defined as the time from randomization until death from any cause.
| Months | ABT-165 Plus FOLFIRI | Bevacizumab Plus FOLFIRI |
|---|---|---|
| Overall Survival (OS) | 7.95 (7.00 to NA) | NA (10.55 to NA) |
Collected over Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ABT-165 Plus FOLFIRI | 12/34 (35.3%) | 17/34 (50%) | 32/34 (94.1%) |
| Bevacizumab Plus FOLFIRI | 6/32 (18.8%) | 8/32 (25%) | 31/32 (96.9%) |
| Event | ABT-165 Plus FOLFIRI | Bevacizumab Plus FOLFIRI |
|---|---|---|
| MALIGNANT NEOPLASM PROGRESSIONNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/34 | 2/32 |
| FEBRILE NEUTROPENIABlood and lymphatic system disorders | 2/34 | 1/32 |
| INTESTINAL PERFORATIONGastrointestinal disorders | 2/34 | 0/32 |
| SEPSISInfections and infestations | 2/34 | 0/32 |
| ANAL HAEMORRHAGEGastrointestinal disorders | 0/34 | 1/32 |
| GASTRIC PERFORATIONGastrointestinal disorders | 0/34 | 1/32 |
| DISEASE PROGRESSIONGeneral disorders | 0/34 | 1/32 |
| BILE DUCT STENOSISHepatobiliary disorders | 0/34 | 1/32 |
| CELLULITISInfections and infestations | 0/34 | 1/32 |
| HEPATITIS BInfections and infestations | 0/34 | 1/32 |
| Event | ABT-165 Plus FOLFIRI | Bevacizumab Plus FOLFIRI |
|---|---|---|
| DIARRHOEAGastrointestinal disorders | 18/34 | 15/32 |
| NAUSEAGastrointestinal disorders | 18/34 | 14/32 |
| NEUTROPENIABlood and lymphatic system disorders | 14/34 | 12/32 |
| FATIGUEGeneral disorders | 14/34 | 13/32 |
| STOMATITISGastrointestinal disorders | 7/34 | 10/32 |
| HYPERTENSIONVascular disorders | 10/34 | 4/32 |
| VOMITINGGastrointestinal disorders | 5/34 | 9/32 |
| CONSTIPATIONGastrointestinal disorders | 8/34 | 5/32 |
| DECREASED APPETITEMetabolism and nutrition disorders | 8/34 | 7/32 |
| DIZZINESSNervous system disorders | 7/34 | 2/32 |
| Age, Continuous(years) | ABT-165 Plus FOLFIRI | Bevacizumab Plus FOLFIRI | Total |
|---|---|---|---|
| Mean | 60.8 ± 11.41 | 60.2 ± 10.19 | 60.5 ± 10.76 |
| Sex: Female, Male(Participants) | ABT-165 Plus FOLFIRI | Bevacizumab Plus FOLFIRI | Total |
|---|---|---|---|
| Female | 15 | 15 | 30 |
| Male | 21 | 19 | 40 |
| Ethnicity (NIH/OMB)(Participants) | ABT-165 Plus FOLFIRI | Bevacizumab Plus FOLFIRI | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 3 | 5 |
| Not Hispanic or Latino | 34 | 31 | 65 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | ABT-165 Plus FOLFIRI | Bevacizumab Plus FOLFIRI | Total |
|---|---|---|---|
| White | 20 | 20 | 40 |
| Black or African American | 2 | 1 | 3 |
| Asian | 11 | 11 | 22 |
| American Indian or Alaska native | 1 | 0 | 1 |
| Native Hawaiian or other Pacific Islander | 1 | 0 | 1 |
| Missing | 1 | 2 | 3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting information: Study protocol, Sap, Csr
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