Trial · NCT01034631

BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma

NCT01034631, Phase 1, Phase 2, Completed, Hoosier Cancer Research Network; results first posted 2017-05-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma. Trials, record NCT01034631. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01034631

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma
NCT number: NCT01034631
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 154 participants, actual
Lead sponsor: Hoosier Cancer Research Network
Conditions: Renal Cell Carcinoma
Interventions: Everolimus, BNC105P
First posted: 2009-12-17
Last updated: 2022-07-11
Results first posted: 2017-05-24

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Phase I: Maximum Tolerated Dose of BNC105P in Combination With Everolimus.	Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months	Phase I
Primary	Phase I: Toxicities of BNC105P in Combination With Everolimus.	Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months	Determine the toxicities of BNC105P in combination with everolimus. Drug-related treatment emergent adverse events by CTCAE grade 2 or greater are reported
Primary	Phase II: 6-month Progression Free Survival (PFS) With the Addition of BNC105P to Everolimus.	6 months	Improvement in 6-month PFS with the addition of BNC105P to everolimus. Progression is defined using RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Secondary	Phase I: Response Rate of BNC105P in Combination With Everolimus.	Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months	Number of objective responses per RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Secondary	Geometric Mean Half-life of BNC105 and BNC105P in Combination With Everolimus.	12 months	Determine the PK Profile for BN105P in combination with everolimus by calculating the geometric mean half-life of BNC105P
Secondary	Phase II: Response Rate With Combination Therapy Compared to Everolimus Alone	12 months	Objective response is defined as a confirmed CR or PR per RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Secondary	Phase II: Progression Free Survival (PFS) With BNC105P Alone in Patients After Progressing on Everolimus.	12 months	Median time to progression for arm P participants who crossed over to BNC105P monotherapy after progression. Progression is defined per RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Secondary	Phase II: Adverse Events of Everolimus and BNC105P When Administered as a Combination or Sequential Regimen.	12 months	Determine adverse events of everolimus and BNC105P when administered as a combination or sequential regimen. Total number of serious and non-serious adverse events for Arm A and Arm B are summarized. Complete adverse event information is supplied in the Adverse Events reporting section.
Secondary	Phase II: Overall Survival	60 months	Determine overall survival probability, up to a maximum of 5 years from registration for protocol therapy.
Secondary	Exploratory Objective: Correlation of PFS With Biomarkers	6 months	Exploratory analysis of serum biomarkers were undertaken to generate a potential signature for response. The correlation with 6 month progression free survival P value for four plasma biomarkers is reported.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Phase I: Maximum Tolerated Dose of BNC105P in Combination With Everolimus.	Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months	12 participants completed at least one cycle of combination therapy and were evaluable.	mg/m^2	NUMBER
PRIMARY	Phase I: Toxicities of BNC105P in Combination With Everolimus.	Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months	12 participants who completed at least one cycle of combination therapy.	participants	NUMBER
PRIMARY	Phase II: 6-month Progression Free Survival (PFS) With the Addition of BNC105P to Everolimus.	6 months		probability of 6MPFS	NUMBER
SECONDARY	Phase I: Response Rate of BNC105P in Combination With Everolimus.	Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Geometric Mean Half-life of BNC105 and BNC105P in Combination With Everolimus.	12 months	14 participants has sufficient data collected for the analysis of this objective	hours	GEOMETRIC_MEAN
SECONDARY	Phase II: Response Rate With Combination Therapy Compared to Everolimus Alone	12 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Phase II: Progression Free Survival (PFS) With BNC105P Alone in Patients After Progressing on Everolimus.	12 months		months	MEDIAN
SECONDARY	Phase II: Adverse Events of Everolimus and BNC105P When Administered as a Combination or Sequential Regimen.	12 months		number of adverse events	NUMBER
SECONDARY	Phase II: Overall Survival	60 months		probability of OS at 60 months.	NUMBER
SECONDARY	Exploratory Objective: Correlation of PFS With Biomarkers	6 months	Analysis was pre-specified to look at the correlation irrespective of arm.	Correlation with PFS P Value	NUMBER

Source ClinicalTrials.gov

Results by group38

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Phase I: Maximum Tolerated Dose of BNC105P in Combination With Everolimus.	Phase I Participants		16	mg/m^2
Phase I: Toxicities of BNC105P in Combination With Everolimus.	Phase I Participants	AST-SGOT Grade 2	1	participants
Phase I: Toxicities of BNC105P in Combination With Everolimus.	Phase I Participants	Cough Grade 2	1	participants
Phase I: Toxicities of BNC105P in Combination With Everolimus.	Phase I Participants	Dyspepsia Grade 2	1	participants
Phase I: Toxicities of BNC105P in Combination With Everolimus.	Phase I Participants	Hemoglobin Grade 2	4	participants
Phase I: Toxicities of BNC105P in Combination With Everolimus.	Phase I Participants	Hemoglobin Grade 3	1	participants
Phase I: Toxicities of BNC105P in Combination With Everolimus.	Phase I Participants	Hypomagnesia Grade 2	1	participants
Phase I: Toxicities of BNC105P in Combination With Everolimus.	Phase I Participants	Low Platelets Grade 2	1	participants
Phase I: Toxicities of BNC105P in Combination With Everolimus.	Phase I Participants	Weight Loss Grade 2	1	participants
Phase I: Toxicities of BNC105P in Combination With Everolimus.	Phase I Participants	Fatigue Grade 2	2	participants

1 to 10 of 38Source ClinicalTrials.gov

See all 38 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Phase I	STARTED	Phase I Participants	15
Phase I	STARTED	Phase II: Arm A	0
Phase I	STARTED	Phase II: Arm B Participants	0
Phase I	COMPLETED	Phase I Participants	12
Phase I	COMPLETED	Phase II: Arm A	0
Phase I	COMPLETED	Phase II: Arm B Participants	0
Phase I	NOT COMPLETED	Phase I Participants	3
Phase I	NOT COMPLETED	Phase II: Arm A	0
Phase I	NOT COMPLETED	Phase II: Arm B Participants	0
Phase II	STARTED	Phase I Participants	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events840

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	ACIDOSIS (METABOLIC OR RESPIRATORY)	Metabolism and nutrition disorders	Phase I Participants	1	15	1
other	ACIDOSIS (METABOLIC OR RESPIRATORY)	Metabolism and nutrition disorders	Phase II: Arm A	1	70	1
other	ACIDOSIS (METABOLIC OR RESPIRATORY)	Metabolism and nutrition disorders	Phase II: Arm B Participants	0	69	0
other	ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)	Investigations	Phase I Participants	2	15	3
other	ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)	Investigations	Phase II: Arm A	7	70	11
other	ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)	Investigations	Phase II: Arm B Participants	7	69	8
other	ALKALINE PHOSPHATASE	Investigations	Phase I Participants	5	15	6
other	ALKALINE PHOSPHATASE	Investigations	Phase II: Arm A	10	70	14
other	ALKALINE PHOSPHATASE	Investigations	Phase II: Arm B Participants	14	69	19
other	ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)	Immune system disorders	Phase I Participants	1	15	3

1 to 10 of 840Source ClinicalTrials.gov

See all 840 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase I Participants
Total, all-cause mortality	Phase II: Arm A
Total, all-cause mortality	Phase II: Arm B Participants
Total, other adverse events	Phase I Participants	15	15
Total, other adverse events	Phase II: Arm A	70	70
Total, other adverse events	Phase II: Arm B Participants	69	69
Total, serious adverse events	Phase I Participants	9	15
Total, serious adverse events	Phase II: Arm A	22	70
Total, serious adverse events	Phase II: Arm B Participants	31	69

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25788492	RESULT	PubMed
34108261	DERIVED	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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Combination Arm A: Everolimus + BNC105P vs Sequential Arm B:Everolimus Followed by BNC105P Monotherapy: Phase II: Response Rate With Combination Therapy Compared to Everolimus Alone

Source Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01034631

GET https://conductscience.org/api/trials/v1/NCT01034631/results?page=2

API reference For AI assistants