Trial · NCT02667886
Trial of X4P-001 in Participants With Advanced Renal Cell Carcinoma
NCT02667886, Phase 1, Phase 2, Completed, X4 Pharmaceuticals; results first posted 2024-08-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of X4P-001 in Participants With Advanced Renal Cell Carcinoma. Trials, record NCT02667886. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02667886
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of X4P-001 in Participants With Advanced Renal Cell Carcinoma
- NCT number
- NCT02667886
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 74 participants, actual
- Lead sponsor
- X4 Pharmaceuticals
- Conditions
- Clear Cell Renal Cell Carcinoma
- Interventions
- X4P-001, axitinib
- First posted
- 2016-01-29
- Last updated
- 2024-10-03
- Results first posted
- 2024-08-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug up to 10 days after last dosing (maximum exposure: 52.1 months) | An AE was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), important medical event or reaction. Adverse events with onset after administration of the first dose of study drug up to 10 days after last dosing date were considered TEAEs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. |
| Secondary | Parts A and B: Objective Response Rate (ORR), as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | From administration of first dose of study medication until disease progression, study completion or early termination (up to 80 weeks) | The ORR was defined as percentage of participants with best overall response of complete response (CR) or partial response (PR). CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) with a reduction in short axis to \<10 millimeters (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Parts A and B: Time to Objective Response, as Assessed Using RECIST v1.1 | From administration of first dose of study medication until first appearance of CR or PR (up to 80 weeks) | Time to objective response was defined as time from first administration of combination regimen to first CR or PR whichever came first. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) with a reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Parts A and B: Duration of Objective Response (DOR), as Assessed Using RECIST v1.1 | Time from first CR or PR until the time of disease progression or death due to any cause (up to 80 weeks) | The DOR was defined as the time from first CR or PR whichever came first until the time of disease progression or death by any cause. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) with a reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of 1 or more new lesions was also considered progression. |
| Secondary | Parts A and B: Disease Control Rate (DCR), as Assessed Using RECIST v1.1 | From administration of first dose of study medication until disease progression, study completion or early termination (up to 80 weeks) | The DCR was defined as the percentage of participants with best overall response of CR, PR or stable disease (SD). CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) with a reduction in short axis to \<10 mm. 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 progressive disease (PD), taking as reference the smallest sum diameters while on study. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of 1 or more new lesions was also considered progression. |
| Secondary | Parts A and B: Time to Progression (TTP), as Assessed Using RECIST v1.1 | From administration of first dose of study medication until disease progression (up to 80 weeks) | The TTP was defined as the time from first administration of combination regimen until PD. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions or the appearance of 1 or more new lesions was also considered progression. |
| Secondary | Parts A and B: Progression Free Survival (PFS), as Assessed Using RECIST v1.1 | From administration of first dose of study medication until disease progression or death from any cause (up to 80 weeks) | The PFS was defined as the time from first administration of combination regimen until disease progression or death from any cause. Disease progression: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. An unequivocal progression of existing non-target lesions or the appearance of 1 or more new lesions was also considered progression. |
| Secondary | Parts A and B: Maximum Plasma Concentration (Cmax) of X4P-001 | Day 1 and Day 15 of Cycle 1 | |
| Secondary | Area Under the Curve From Time 0 to the Last Quantifiable Timepoint (AUC0-tlast) | Day 1 and Day 15 of Cycle 1 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug up to 10 days after last dosing (maximum exposure: 52.1 months) | Safety population included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Parts A and B: Objective Response Rate (ORR), as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | From administration of first dose of study medication until disease progression, study completion or early termination (up to 80 weeks) | Clinically evaluable population included all participants who received at least 1 dose of study medication, who had at least 1 valid post-baseline response (CR/PR/stable disease \[SD\]/progressive disease \[PD\]) and had no major protocol deviations which impacted the efficacy assessment. Due to dose-limiting toxicities (DLTs) experienced by participants, the sample size was too small for data to be collected for this Outcome Measure for the X4P-001 600 mg QD With Axitinib arm. | percentage of participants | NUMBER |
| SECONDARY | Parts A and B: Time to Objective Response, as Assessed Using RECIST v1.1 | From administration of first dose of study medication until first appearance of CR or PR (up to 80 weeks) | Clinically evaluable population included all participants who received at least 1 dose of study medication, who had at least 1 valid post-baseline response (CR/PR/SD/PD) and had no major protocol deviations which impacted the efficacy assessment. Due to DLTs experienced by participants, the sample size was too small for data to be collected for this Outcome Measure for the X4P-001 600 mg QD With Axitinib arm. | months | MEDIAN |
| SECONDARY | Parts A and B: Duration of Objective Response (DOR), as Assessed Using RECIST v1.1 | Time from first CR or PR until the time of disease progression or death due to any cause (up to 80 weeks) | Clinically evaluable population included all participants who received at least 1 dose of study medication, who had at least 1 valid post-baseline response (CR/PR/SD/PD) and had no major protocol deviations which impacted efficacy assessment. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. Due to DLTs experienced by participants, the sample size was too small for data to be collected for this Outcome Measure for X4P-001 600 mg QD With Axitinib arm. | months | MEDIAN |
| SECONDARY | Parts A and B: Disease Control Rate (DCR), as Assessed Using RECIST v1.1 | From administration of first dose of study medication until disease progression, study completion or early termination (up to 80 weeks) | Clinically evaluable population included all participants who received at least 1 dose of study medication, who had at least 1 valid post-baseline response (CR/PR/SD/PD) and had no major protocol deviations which impacted the efficacy assessment. Due to DLTs experienced by participants, the sample size was too small for data to be collected for this Outcome Measure for the X4P-001 600 mg QD With Axitinib arm. | percentage of participants | NUMBER |
| SECONDARY | Parts A and B: Time to Progression (TTP), as Assessed Using RECIST v1.1 | From administration of first dose of study medication until disease progression (up to 80 weeks) | Clinically evaluable population included all participants who received at least 1 dose of study medication, who had at least 1 valid post-baseline response (CR/PR/SD/PD) and had no major protocol deviations which impacted the efficacy assessment. Due to DLTs experienced by participants, the sample size was too small for data to be collected for this Outcome Measure for the X4P-001 600 mg QD With Axitinib arm. | months | MEDIAN |
| SECONDARY | Parts A and B: Progression Free Survival (PFS), as Assessed Using RECIST v1.1 | From administration of first dose of study medication until disease progression or death from any cause (up to 80 weeks) | Clinically evaluable population included all participants who received at least 1 dose of study medication, who had at least 1 valid post-baseline response (CR/PR/SD/PD) and had no major protocol deviations which impacted the efficacy assessment. Due to DLTs experienced by participants, the sample size was too small for data to be collected for this Outcome Measure for the X4P-001 600 mg QD With Axitinib arm. | months | MEDIAN |
| SECONDARY | Parts A and B: Maximum Plasma Concentration (Cmax) of X4P-001 | Day 1 and Day 15 of Cycle 1 | The pharmacokinetic (PK) population included all participants who had at least one evaluable concentration. Here 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | nanograms (ng)/milliliter (mL) | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Curve From Time 0 to the Last Quantifiable Timepoint (AUC0-tlast) | Day 1 and Day 15 of Cycle 1 | The PK population included all participants who had at least one evaluable concentration. Here 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | hours*ng/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | X4P-001 200 mg BID With Axitinib | 3 | Participants | ||
| Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | X4P-001 400 mg QD With Axitinib | 62 | Participants | ||
| Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | X4P-001 600 mg QD With Axitinib | 6 | Participants | ||
| Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | X4P-001 600 mg QD Monotherapy | 3 | Participants | ||
| Parts A and B: Objective Response Rate (ORR), as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | X4P-001 200 mg BID With Axitinib | 66.7 | 95% Confidence Interval 9.4 to 99.2 | percentage of participants | |
| Parts A and B: Objective Response Rate (ORR), as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | X4P-001 400 mg QD With Axitinib | 27.1 | 95% Confidence Interval 16.4 to 40.3 | percentage of participants | |
| Parts A and B: Time to Objective Response, as Assessed Using RECIST v1.1 | X4P-001 200 mg BID With Axitinib | 12.9 | 95% Confidence Interval 1.9 to NA | months | |
| Parts A and B: Time to Objective Response, as Assessed Using RECIST v1.1 | X4P-001 400 mg QD With Axitinib | 14.6 | 95% Confidence Interval 12.9 to NA | months | |
| Parts A and B: Duration of Objective Response (DOR), as Assessed Using RECIST v1.1 | X4P-001 200 mg BID With Axitinib | NA | 95% Confidence Interval 9.2 to NA | months | |
| Parts A and B: Duration of Objective Response (DOR), as Assessed Using RECIST v1.1 | X4P-001 400 mg QD With Axitinib | 16.6 | 95% Confidence Interval 10.8 to 36.0 | months |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation (Part A) | STARTED | Dose Escalation (Part A): X4P-001 200 mg BID With Axitinib | 3 | |
| Dose Escalation (Part A) | STARTED | Dose Escalation (Part A): X4P-001 400 mg QD With Axitinib | 7 | |
| Dose Escalation (Part A) | STARTED | Dose Escalation (Part A): X4P-001 600 mg QD With Axitinib | 6 | |
| Dose Escalation (Part A) | STARTED | Dose Expansion (Part B): X4P-001 400 mg QD With Axitinib | 0 | |
| Dose Escalation (Part A) | STARTED | Dose Escalation and Expansion (Part C): X4P-001 600 mg QD Monotherapy | 0 | |
| Dose Escalation (Part A) | Received at Least 1 Dose of Study Drug | Dose Escalation (Part A): X4P-001 200 mg BID With Axitinib | 3 | |
| Dose Escalation (Part A) | Received at Least 1 Dose of Study Drug | Dose Escalation (Part A): X4P-001 400 mg QD With Axitinib | 7 | |
| Dose Escalation (Part A) | Received at Least 1 Dose of Study Drug | Dose Escalation (Part A): X4P-001 600 mg QD With Axitinib | 6 | |
| Dose Escalation (Part A) | Received at Least 1 Dose of Study Drug | Dose Expansion (Part B): X4P-001 400 mg QD With Axitinib | 0 | |
| Dose Escalation (Part A) | Received at Least 1 Dose of Study Drug | Dose Escalation and Expansion (Part C): X4P-001 600 mg QD Monotherapy | 0 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events1,240
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 | Diarrhoea | Gastrointestinal disorders | X4P-001 200 mg BID With Axitinib | 3 | 3 | |
| other | Diarrhoea | Gastrointestinal disorders | X4P-001 400 mg QD With Axitinib | 33 | 62 | |
| other | Diarrhoea | Gastrointestinal disorders | X4P-001 600 mg QD With Axitinib | 3 | 6 | |
| other | Diarrhoea | Gastrointestinal disorders | X4P-001 600 mg QD Monotherapy | 1 | 3 | |
| other | Nausea | Gastrointestinal disorders | X4P-001 200 mg BID With Axitinib | 2 | 3 | |
| other | Nausea | Gastrointestinal disorders | X4P-001 400 mg QD With Axitinib | 22 | 62 | |
| other | Nausea | Gastrointestinal disorders | X4P-001 600 mg QD With Axitinib | 3 | 6 | |
| other | Nausea | Gastrointestinal disorders | X4P-001 600 mg QD Monotherapy | 2 | 3 | |
| other | Vomiting | Gastrointestinal disorders | X4P-001 200 mg BID With Axitinib | 2 | 3 | |
| other | Vomiting | Gastrointestinal disorders | X4P-001 400 mg QD With Axitinib | 20 | 62 |
1 to 10 of 1,240Source ClinicalTrials.gov
See all 1,240 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | X4P-001 200 mg BID With Axitinib | 1 | 3 |
| Total, all-cause mortality | X4P-001 400 mg QD With Axitinib | 2 | 62 |
| Total, all-cause mortality | X4P-001 600 mg QD With Axitinib | 1 | 6 |
| Total, all-cause mortality | X4P-001 600 mg QD Monotherapy | 3 | 3 |
| Total, other adverse events | X4P-001 200 mg BID With Axitinib | 3 | 3 |
| Total, other adverse events | X4P-001 400 mg QD With Axitinib | 62 | 62 |
| Total, other adverse events | X4P-001 600 mg QD With Axitinib | 6 | 6 |
| Total, other adverse events | X4P-001 600 mg QD Monotherapy | 3 | 3 |
| Total, serious adverse events | X4P-001 200 mg BID With Axitinib | 1 | 3 |
| Total, serious adverse events | X4P-001 400 mg QD With Axitinib | 26 | 62 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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