Trial · NCT02599324
Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors
NCT02599324, Phase 1, Phase 2, Completed, Pharmacyclics LLC.; results first posted 2022-10-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors. Trials, record NCT02599324. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02599324
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors
- NCT number
- NCT02599324
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 263 participants, actual
- Lead sponsor
- Pharmacyclics LLC.
- Conditions
- Metastatic Renal Cell Carcinoma, Advanced Urothelial Carcinoma, Advanced Gastric Adenocarcinoma, Metastatic Colorectal Adenocarcinoma
- Interventions
- ibrutinib, everolimus, paclitaxel, docetaxel, cetuximab, pembrolizumab
- First posted
- 2015-11-06
- Last updated
- 2023-11-18
- Other registries' IDs
- eudract:2015-003656-40
- Results first posted
- 2022-10-26
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLTs) in Cohorts 1 to 6 | 21 days after the initiation of therapy at the start of Cycle 1 | A DLT was defined as any Grade 3 (severe) or higher non-hematologic or Grade 4 (life-threatening) hematologic adverse event (AE) occurring during the DLT observation period that was considered to be at least possibly related to the study treatment (ibrutinib or drug combination). |
| Primary | Phase 1b/2 RP2D: Progression-Free Survival (PFS) as Assessed by Investigator in Cohorts 1 and 2 | Maximum time on study for Cohort 1 (Phase 1b/2 RP2D) was 37.4 months; for Cohort 2 (Phase 1b/2 RP2D) was 44.7 months. | PFS is defined as the time from the date of first dose of study treatment to the date of first documentation of progressive disease (PD) or date of death from any cause, whichever occurs first, regardless of the use of subsequent anti-cancer treatment. PD was defined in accordance with Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions. |
| Primary | Phase 1b/2 RP2D: Overall Response Rate (ORR) as Assessed by Investigator in Cohorts 3 to 6 | Maximum time on study (Phase 1b/2 RP2D) for Cohort 3 was 41.9 months; for Cohort 4 was 23.5 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. | ORR is defined as the percentage of participants who have a best response of partial response (PR) or complete response (CR) to therapy in accordance with RECIST 1.1 criteria. CR: The disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Normalization of tumor marker level, if relevant. All lymph nodes must be non-pathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Phase 1b: ORR in Cohorts 1 to 6 | Maximum time on study (Phase 1b only) for Cohort 1 was 37.4 months; for Cohort 2 was 44.7 months; for Cohort 3 was 41.9 months; for Cohort 4 was 34.2 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. | ORR is defined as the percentage of participants who have a best response of partial response (PR) or complete response (CR) to therapy in accordance with RECIST 1.1 criteria. CR: The disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Normalization of tumor marker level, if relevant. All lymph nodes must be non-pathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Phase 1b: Disease Control Rate (DCR) in Cohorts 1 to 6 | Maximum time on study (Phase 1b only) for Cohort 1 was 37.4 months; for Cohort 2 was 44.7 months; for Cohort 3 was 41.9 months; for Cohort 4 was 34.2 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. | DCR is is defined as the percentage of participants who have a best response of PR, CR, or stable disease (SD) to therapy in accordance with RECIST 1.1 criteria. CR: The disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Normalization of tumor marker level, if relevant. All lymph nodes must be non-pathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD since the treatment started (baseline or after). For SD, tthere was no need for confirmation by a subsequent imaging assessment. |
| Secondary | Phase 1b/2 RP2D: DCR in Cohorts 1 to 6 | Maximum time on study (Phase 1b/2 RP2D) for Cohort 1 was 37.4 months; for Cohort 2 was 44.7 months; for Cohort 3 was 41.9 months; for Cohort 4 was 23.5 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. (Reverse Kaplan-Meier estimates) | DCR is is defined as the percentage of participants who have a best response of PR, CR, or SD to therapy in accordance with RECIST 1.1 criteria. CR: The disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Normalization of tumor marker level, if relevant. All lymph nodes must be non-pathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD since the treatment started (baseline or after). For SD, tthere was no need for confirmation by a subsequent imaging assessment. |
| Secondary | Phase 1b/2 RP2D: PFS in Cohorts 3 to 6 | Maximum time on study (Phase 1b/2 RP2D) for Cohort 3 was 41.9 months; for Cohort 4 was 23.5 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. (Reverse Kaplan-Meier estimates) | PFS is defined as the time from the date of first dose of study treatment to the date of first documentation of PD or date of death from any cause, whichever occurs first, regardless of the use of subsequent anti-cancer treatment. PD was defined in accordance with RECIST 1.1 criteria. |
| Secondary | Phase 1b/2 RP2D: ORR in Cohorts 1 and 2 | Maximum time on study for Cohort 1 (Phase 1b/2 RP2D) was 37.4 months; for Cohort 2 (Phase 1b/2 RP2D) was 44.7 months. (Reverse Kaplan-Meier estimates) | ORR is defined as the percentage of participants who have a best response to therapy of PR or CR in accordance with RECIST 1.1 criteria. CR: The disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Normalization of tumor marker level, if relevant. All lymph nodes must be non-pathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Phase 1b/2 RP2D: Overall Survival (OS) in Cohorts 1 to 6 | Maximum time on study (Phase 1b/2 RP2D) for Cohort 1 was 37.4 months; for Cohort 2 was 44.7 months; for Cohort 3 was 41.9 months; for Cohort 4 was 23.5 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. (Reverse Kaplan-Meier estimates) | OS is defined as the time from the date of first dose of study treatment to the date of death from any cause. Subjects who were not known to have died at the data extraction will be censored at date last known alive. |
| Secondary | Phase 1b/2 RP2D: Duration of Response (DOR) in Cohorts 1 to 6 | Maximum time on study (Phase 1b/2 RP2D) for Cohort 1 was 37.4 months; for Cohort 2 was 44.7 months; for Cohort 3 was 41.9 months; for Cohort 4 was 23.5 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. (Reverse Kaplan-Meier estimates) | DOR is defined for confirmed responders (PR or better) as time from the date of initial response (PR or better) to the date of first documentation of PD (according to RECIST 1.1) or death, whichever occurs first, regardless of use of subsequent anti-cancer treatment. Confirmed responders without documentation of PD or death or with unknown status at the data extraction were censored at the last adequate post-baseline disease assessment showing no evidence of PD. PD was defined as at least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. Per protocol, participants in Phase 1b receiving the Phase 2 RP2D and participants in Phase 2 RP2D were analyzed together. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLTs) in Cohorts 1 to 6 | 21 days after the initiation of therapy at the start of Cycle 1 | DLT Evaluable Population: participants from Phase 1b who completed at least 21 days of treatment with ibrutinib in combination with the relevant anticancer agent after the initiation of study treatment at the start of Cycle 1, or those who discontinued from study treatment due to a DLT event prior to completion of DLT observation period. For UC Cohorts 5 and 6, a DLT-evaluable participant had ≥ 90% compliance with ibrutinib during Cycle 1 (the first 21 days). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1b/2 RP2D: Progression-Free Survival (PFS) as Assessed by Investigator in Cohorts 1 and 2 | Maximum time on study for Cohort 1 (Phase 1b/2 RP2D) was 37.4 months; for Cohort 2 (Phase 1b/2 RP2D) was 44.7 months. | Efficacy Evaluable Population: Participants who received at least one dose of ibrutinib (at RP2D) in combination with at least one dose of the relevant companion drug and had at least one adequate post-baseline overall disease assessment per RECIST 1.1 guidelines or died prior to the first adequate post-baseline overall disease assessment. Per protocol, participants in Phase 1b receiving the Phase 2 RP2D and participants in Phase 2 RP2D were analyzed together. | months | MEDIAN |
| PRIMARY | Phase 1b/2 RP2D: Overall Response Rate (ORR) as Assessed by Investigator in Cohorts 3 to 6 | Maximum time on study (Phase 1b/2 RP2D) for Cohort 3 was 41.9 months; for Cohort 4 was 23.5 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. | Efficacy Evaluable Population (Phase 1b/2 RP2D): participants who received ≥ 1 dose of ibrutinib (at RP2D) in combination with ≥ 1 dose of the relevant companion drug or ibrutinib (at RP2D) for the single-agent therapy and: 1) Had measurable disease per RECIST 1.1 guidelines at baseline. 2) Had ≥ 1 adequate post-baseline overall disease assessment per RECIST 1.1 guidelines. Per protocol, participants in Phase 1b receiving the Phase 2 RP2D and participants in Phase 2 RP2D were analyzed together. | percentage of participants | NUMBER |
| SECONDARY | Phase 1b: ORR in Cohorts 1 to 6 | Maximum time on study (Phase 1b only) for Cohort 1 was 37.4 months; for Cohort 2 was 44.7 months; for Cohort 3 was 41.9 months; for Cohort 4 was 34.2 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. | Efficacy Evaluable Population (Phase 1b): participants who received at least one dose of ibrutinib (at RP2D) in combination with at least one dose of the relevant companion drug or ibrutinib (at RP2D) for the single-agent therapy and: 1) Had measurable disease per RECIST 1.1 guidelines at baseline. 2) Had at least one adequate post-baseline overall disease assessment per RECIST 1.1 guidelines. | percentage of participants | NUMBER |
| SECONDARY | Phase 1b: Disease Control Rate (DCR) in Cohorts 1 to 6 | Maximum time on study (Phase 1b only) for Cohort 1 was 37.4 months; for Cohort 2 was 44.7 months; for Cohort 3 was 41.9 months; for Cohort 4 was 34.2 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. | Efficacy Evaluable Population (Phase 1b): participants who received at least one dose of ibrutinib (at RP2D) in combination with at least one dose of the relevant companion drug or ibrutinib (at RP2D) for the single-agent therapy and: 1) Had measurable disease per RECIST 1.1 guidelines at baseline. 2) Had at least one adequate post-baseline overall disease assessment per RECIST 1.1 guidelines. | percentage of participants | NUMBER |
| SECONDARY | Phase 1b/2 RP2D: DCR in Cohorts 1 to 6 | Maximum time on study (Phase 1b/2 RP2D) for Cohort 1 was 37.4 months; for Cohort 2 was 44.7 months; for Cohort 3 was 41.9 months; for Cohort 4 was 23.5 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. (Reverse Kaplan-Meier estimates) | Efficacy Evaluable Population (Phase 1b/2 RP2D): participants who received ≥ 1 dose of ibrutinib (at RP2D) in combination with ≥ 1 dose of the relevant companion drug or ibrutinib (at RP2D) for the single-agent therapy and: 1) Had measurable disease per RECIST 1.1 guidelines at baseline. 2) Had ≥ 1 adequate post-baseline overall disease assessment per RECIST 1.1 guidelines. Per protocol, participants in Phase 1b receiving the Phase 2 RP2D and participants in Phase 2 RP2D were analyzed together. | percentage of participants | NUMBER |
| SECONDARY | Phase 1b/2 RP2D: PFS in Cohorts 3 to 6 | Maximum time on study (Phase 1b/2 RP2D) for Cohort 3 was 41.9 months; for Cohort 4 was 23.5 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. (Reverse Kaplan-Meier estimates) | Efficacy Evaluable Population (Phase 1b/2 RP2D): participants who received ≥ 1 dose of ibrutinib (at RP2D) in combination with ≥ 1 dose of the relevant companion drug or ibrutinib (at RP2D) for the single-agent therapy and: 1) Had measurable disease per RECIST 1.1 guidelines at baseline. 2) Had ≥ 1 adequate post-baseline overall disease assessment per RECIST 1.1 guidelines. Per protocol, participants in Phase 1b receiving the Phase 2 RP2D and participants in Phase 2 RP2D were analyzed together. | months | MEDIAN |
| SECONDARY | Phase 1b/2 RP2D: ORR in Cohorts 1 and 2 | Maximum time on study for Cohort 1 (Phase 1b/2 RP2D) was 37.4 months; for Cohort 2 (Phase 1b/2 RP2D) was 44.7 months. (Reverse Kaplan-Meier estimates) | Efficacy Evaluable Population (Phase 1b/2 RP2D): participants who received ≥ 1 dose of ibrutinib (at RP2D) in combination with ≥ 1 dose of the relevant companion drug or ibrutinib (at RP2D) for the single-agent therapy and: 1) Had measurable disease per RECIST 1.1 guidelines at baseline. 2) Had ≥ 1 adequate post-baseline overall disease assessment per RECIST 1.1 guidelines. Per protocol, participants in Phase 1b receiving the Phase 2 RP2D and participants in Phase 2 RP2D were analyzed together. | percentage of participants | NUMBER |
| SECONDARY | Phase 1b/2 RP2D: Overall Survival (OS) in Cohorts 1 to 6 | Maximum time on study (Phase 1b/2 RP2D) for Cohort 1 was 37.4 months; for Cohort 2 was 44.7 months; for Cohort 3 was 41.9 months; for Cohort 4 was 23.5 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. (Reverse Kaplan-Meier estimates) | Efficacy Evaluable Population (Phase 1b/2 RP2D): participants who received ≥ 1 dose of ibrutinib (at RP2D) in combination with ≥ 1 dose of the relevant companion drug or ibrutinib (at RP2D) for the single-agent therapy and: 1) Had measurable disease per RECIST 1.1 guidelines at baseline. 2) Had ≥ 1 adequate post-baseline overall disease assessment per RECIST 1.1 guidelines. Per protocol, participants in Phase 1b receiving the Phase 2 RP2D and participants in Phase 2 RP2D were analyzed together. | months | MEDIAN |
| SECONDARY | Phase 1b/2 RP2D: Duration of Response (DOR) in Cohorts 1 to 6 | Maximum time on study (Phase 1b/2 RP2D) for Cohort 1 was 37.4 months; for Cohort 2 was 44.7 months; for Cohort 3 was 41.9 months; for Cohort 4 was 23.5 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. (Reverse Kaplan-Meier estimates) | Confirmed responders in Efficacy Evaluable Population (Phase 1b/2 RP2D): participants who received ≥ 1 dose of ibrutinib (at RP2D) in combination with ≥ 1 dose of the relevant companion drug or ibrutinib (at RP2D) for the single-agent therapy and: 1) Had measurable disease per RECIST 1.1 guidelines at baseline. 2) Had ≥ 1 adequate post-baseline overall disease assessment per RECIST 1.1 guidelines. | months | MEDIAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group161
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLTs) in Cohorts 1 to 6 | Cohort 1 (RCC): Ibrutinib 560 mg + Everolimus | 0 | Participants | ||
| Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLTs) in Cohorts 1 to 6 | Cohort 1 (RCC): Ibrutinib 840 mg + Everolimus | 1 | Participants | ||
| Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLTs) in Cohorts 1 to 6 | Cohort 2 (UC): Ibrutinib 560 mg + Paclitaxel | 0 | Participants | ||
| Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLTs) in Cohorts 1 to 6 | Cohort 2 (UC): Ibrutinib 840 mg + Paclitaxel | 0 | Participants | ||
| Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLTs) in Cohorts 1 to 6 | Cohort 3 (GA): Ibrutinib 560 mg + Docetaxel | 2 | Participants | ||
| Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLTs) in Cohorts 1 to 6 | Cohort 4 (CRC): Ibrutinib 560 mg + Cetuximab | 0 | Participants | ||
| Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLTs) in Cohorts 1 to 6 | Cohort 4 (CRC): Ibrutinib 840 mg + Cetuximab | 0 | Participants | ||
| Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLTs) in Cohorts 1 to 6 | Cohort 5 (UC): Ibrutinib 840 mg | 0 | Participants | ||
| Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLTs) in Cohorts 1 to 6 | Cohort 6 (UC): Ibrutinib 560 mg + Pembrolizumab | 0 | Participants | ||
| Phase 1b/2 RP2D: Progression-Free Survival (PFS) as Assessed by Investigator in Cohorts 1 and 2 | Cohort 1 (RCC): Ibrutinib 840 mg + Everolimus | 5.6 | 90% Confidence Interval 3.9 to 7.5 | months |
1 to 10 of 161Source ClinicalTrials.gov
See all 161 results by groupParticipant flow81
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1b | STARTED | Cohort 1 (RCC): Ibrutinib 560 mg + Everolimus | 3 | |
| Phase 1b | STARTED | Cohort 1 (RCC): Ibrutinib 840 mg + Everolimus | 7 | |
| Phase 1b | STARTED | Cohort 2 (UC): Ibrutinib 560 mg + Paclitaxel | 4 | |
| Phase 1b | STARTED | Cohort 2 (UC): Ibrutinib 840 mg + Paclitaxel | 10 | |
| Phase 1b | STARTED | Cohort 3 (GA): Ibrutinib 560 mg + Docetaxel | 21 | |
| Phase 1b | STARTED | Cohort 4 (CRC): Ibrutinib 560 mg + Cetuximab | 8 | |
| Phase 1b | STARTED | Cohort 4 (CRC): Ibrutinib 840 mg + Cetuximab | 12 | |
| Phase 1b | STARTED | Cohort 5 (UC): Ibrutinib 840 mg | 10 | |
| Phase 1b | STARTED | Cohort 6 (UC): Ibrutinib 560 mg + Pembrolizumab | 17 | |
| Phase 1b | COMPLETED | Cohort 1 (RCC): Ibrutinib 560 mg + Everolimus | 3 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 participant flowAdverse events6,030
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 1 (RCC) Phase 1b: Ibrutinib 560 mg + Everolimus | 2 | 3 | 5 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 1 (RCC) Phase 1b: Ibrutinib 840 mg + Everolimus | 2 | 7 | 16 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 1 (RCC) Phase 2: Ibrutinib 840 mg + Everolimus | 19 | 38 | 58 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 2 (UC) Phase 1b: Ibrutinib 560 mg + Paclitaxel | 1 | 4 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 2 (UC) Phase 1b: Ibrutinib 840 mg + Paclitaxel | 4 | 10 | 7 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 2 (UC) Phase 2: Ibrutinib 840 mg + Paclitaxel | 20 | 55 | 57 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 3 (GA) Phase 1b: Ibrutinib 560 mg + Docetaxel | 8 | 21 | 32 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 3 (GA) Phase 2 (RP2D): Ibrutinib 560 mg + Docetaxel | 16 | 31 | 33 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 4 (CA) Phase 1b: Ibrutinib 560 mg + Cetuximab | 1 | 8 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 4 (CA) Phase 1b: Ibrutinib 840 mg + Cetuximab | 1 | 12 | 1 |
1 to 10 of 6,030Source ClinicalTrials.gov
See all 6,030 adverse eventsAdverse event totals45
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 (RCC) Phase 1b: Ibrutinib 560 mg + Everolimus | 3 | 3 |
| Total, all-cause mortality | Cohort 1 (RCC) Phase 1b: Ibrutinib 840 mg + Everolimus | 1 | 7 |
| Total, all-cause mortality | Cohort 1 (RCC) Phase 2: Ibrutinib 840 mg + Everolimus | 22 | 38 |
| Total, all-cause mortality | Cohort 2 (UC) Phase 1b: Ibrutinib 560 mg + Paclitaxel | 3 | 4 |
| Total, all-cause mortality | Cohort 2 (UC) Phase 1b: Ibrutinib 840 mg + Paclitaxel | 4 | 10 |
| Total, all-cause mortality | Cohort 2 (UC) Phase 2: Ibrutinib 840 mg + Paclitaxel | 51 | 55 |
| Total, all-cause mortality | Cohort 3 (GA) Phase 1b: Ibrutinib 560 mg + Docetaxel | 13 | 21 |
| Total, all-cause mortality | Cohort 3 (GA) Phase 2 (RP2D): Ibrutinib 560 mg + Docetaxel | 17 | 31 |
| Total, all-cause mortality | Cohort 4 (CA) Phase 1b: Ibrutinib 560 mg + Cetuximab | 6 | 8 |
| Total, all-cause mortality | Cohort 4 (CA) Phase 1b: Ibrutinib 840 mg + Cetuximab | 4 | 12 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37919668 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02599324
GET https://conductscience.org/api/trials/v1/NCT02599324/results?page=2