Phase 2
N=15
BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma
Renal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01034631 ↗Enrolled (actual)
15
Serious AEs
40.3%
Results posted
May 2017
Primary outcome: Primary: Phase I: Maximum Tolerated Dose of BNC105P in Combination With Everolimus. — 16 mg/m^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Everolimus (Drug); BNC105P (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoosier Cancer Research Network
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase I: Maximum Tolerated Dose of BNC105P in Combination With Everolimus. |
16 | — |
| PRIMARY Phase I: Toxicities of BNC105P in Combination With Everolimus. |
1; 1; 1; 4; 1; 1 | — |
| PRIMARY Phase II: 6-month Progression Free Survival (PFS) With the Addition of BNC105P to Everolimus. |
.3382; .3030 | .6625 |
| SECONDARY Phase I: Response Rate of BNC105P in Combination With Everolimus. |
0; 0; 8; 4; 3 | — |
| SECONDARY Geometric Mean Half-life of BNC105 and BNC105P in Combination With Everolimus. |
.32; .08 | — |
| SECONDARY Phase II: Response Rate With Combination Therapy Compared to Everolimus Alone |
1; 1 | — |
| SECONDARY Phase II: Progression Free Survival (PFS) With BNC105P Alone in Patients After Progressing on Everolimus. |
1.8 | — |
| SECONDARY Phase II: Adverse Events of Everolimus and BNC105P When Administered as a Combination or Sequential Regimen. |
1419; 1654; 39; 50 | — |
| SECONDARY Phase II: Overall Survival |
.15; .21 | — |
| SECONDARY Exploratory Objective: Correlation of PFS With Biomarkers |
0.0184; 0.0063; 0.0421; 0.0291 | — |
Summary
The purpose of this study is to determine whether BNC105P in combination with/following everolimus is effective in the treatment of progressive metastatic clear cell renal cell carcinoma following prior tyrosine kinase inhibitors.
Eligibility Criteria
Inclusion Criteria
- Histological or cytological proof of component (any percent) of clear cell RCC (renal cell carcinoma).
- Metastatic or locally advanced unresectable RCC. NOTE: Prior nephrectomy is not mandatory.
- Progressive disease after 1-2 prior VEGF-directed tyrosine kinase inhibitors (TKIs).
- Measurable disease according to RECIST and obtained by imaging within 30 days prior to registration for protocol therapy.
- Written informed consent and HIPAA authorization for release of personal health information.
- Age > 18 years at the time of consent.
- Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after treatment discontinuation.
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy.
Exclusion Criteria
- No active brain metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis within 30 days prior to registration on protocol therapy. NOTE: A patient with prior brain metastasis are eligible if they have completed their radiation treatment for brain metastasis ≥30 days prior to registration for protocol therapy, are off steroids, and are asymptomatic.
- No other currently active malignancy.
- No treatment with any investigational agent within 14 days prior to registration for protocol therapy. NOTE: If treated with investigational agent within 14 days prior to registration, AE must be resolved back to baseline.
- Prior cancer treatment must be completed at least 14 days prior to registration for protocol therapy and the patient must have recovered from the acute toxic effects of the regimen. With the exception of Bevacizumab treatment, which must be completed 30 days prior to registration for protocol therapy.
- Prior radiation therapy to 150/100mmHg despite full doses of 1 anti-hypertensive medication).
- No thrombotic event within 6 months (deep vein thrombosis, pulmonary embolism) of registration for protocol therapy.
- No grade 2 or greater peripheral neuropathy.
Data sourced from ClinicalTrials.gov (NCT01034631). 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.