Renal Cell CarcinomaPhase 1NCT02835833
Study of Nintedanib Plus Bevacizumab in Advanced Solid Tumors
A Phase 1 study testing Nintedanib and Bevacizumab in people with Renal Cell Carcinoma and Colorectal Adenocarcinoma, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Angiogenesis, the development of new blood vessels, plays an important role in the disease development and tumor growth in many solid organ malignancies. Bevacizumab was the first anti-angiogenic drug to be approved in solid tumors and has shown advantageous activity with multiple tumor types. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Colorectal Adenocarcinoma, Non-squamous Non-small Cell Lung Cancer
- What is being tested?
- Nintedanib and Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2016to 14 Jun 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18
- Histologically proven advanced or metastatic solid cancer for which Bevacizumab has an indication: renal cell carcinoma, colorectal adenocarcinoma, non-squamous non-small cell lung cancer, platinum- refractory ovarian carcinoma, cervical carcinoma.
- Life expectancy at least 3 months
- ECOG performance status score 0-1
- Progression after at least first-line systemic therapy for metastatic disease
- At least one measurable lesion according to RECIST criteria or any other baseline prerequisite for the assessment of the principal judgement criteria.
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- Signed and dated written informed consent prior to admission to the study
- Resolution of all acute adverse events resulting from prior cancer therapies to NCI CTCAE grade less than/equal to 1 or baseline (except alopecia)
- Adequate organ function as defined by the following criteria
- AST/ALT ≤ 2.5x upper limit of normal (ULN) in the case of liver metastases or AST/ALT ≤ 1.5 x ULN in patients without liver metastases
- total serum bilirubin within normal limits regardless of liver metastases
- absolute neutrophil count (ANC) > 1500
- Platelets > 100k without transfusion support in the past 28 days
- Hemoglobin > 9.0 without transfusion support in the past 28 days
- Serum creatinine < 1.5x ULN
- Prothrombin time/INR and partial thromboplastin time within normal limits
- Urinalysis ≤ 1+ protein
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Who cannot join
- Previous therapy with Bevacizumab is allowed, but patient who experienced serious dose-limiting toxicities while on prior Bevacizumab therapy are excluded
- Prior treatment with Nintedanib (BIBF1120). Known hypersensitivity to Nintedanib, peanut or soya or any other trial drug, their excipients or to contrast media
- Chemo-, hormone-, radio-(except for brain and extremities) or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug.
- Radiotherapy to the target lesion within the past 3 months prior to baseline imaging
- Persistence of clinically relevant therapy related toxicity from previous chemo and/or radiotherapy
- History of brain involvement with cancer, spinal cord compression, carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. Patients with irradiated or resected brain lesions are permitted provided the lesions are fully treated and inactive, patients are asymptomatic, and no steroids have been used for at least 28 days.
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- Leptomeningeal disease
- Centrally located tumours with radiographic evidence of local invasion of major blood vessels
- Treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with the trial
- Therapeutic anticoagulation (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous devise) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid <325mg per day.
- Major injuries and/or surgery within the past 4 weeks prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period.
- History of clinically significant hemorrhagic or thromboembolic event in the past 6 months.
- Known inherited predisposition to bleeding or thrombosis
- Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within the past 6 months prior to start of study treatment, congestive heart failure >New York Heart Association II, serious cardiac arrhythmia, pericardial effusion)
- Proteinuria CTCAE grade 2 or greater
- Creatinine >1.5 ULN or GFR <45 ml/min
- Hepatic function: total bilirubin outside of normal limits; ALT or AST >2.5 ULN in pts without liver metastasis. For patients with liver metastasis: total bilirubin outside of normal limits, ALT or AST >5 x ULN
- Coagulation parameters: International normalized ratio (INR) >2, prothrombin time (PT) and partial thromboplastin time (PTT) >50% of deviation of institutional ULN
- Absolute neutrophil count (ANC) <1500/ml, platelets <100,000/ml, Hemoglobin <9.0 g/dl
- Other malignancies within the past 5 years other than basal cell skin cancer or carcinoma in situ of the cervix
- Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy
- Active or chronic hepatitis C and/or B infection
- Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
- Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study.
- Patients who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least three months after end of active therapy.
- Pregnancy or breast feeding. Female patients must have a negative pregnancy test (β-HCG test in urine or serum) prior to commencing study treatment and must agree with the use of effective contraception during the study and for three months following last dose of Nintedanib.
- Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
- Active alcohol or drug abuse
- Minor surgical procedures such as Mediport placement or core biopsies within 7 days of study treatment
- Stroke, transient ischemic attack, arterial embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) within the past 6 months
- History of pulmonary hemorrhage or hemoptysis within 6 months of starting study treatment
- Open wounds or unhealed fractures within 28 days of starting study treatment
- Known HIV or AIDS related illness
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294
About this study
Official title: Phase I Dose Escalation Study of Nintedanib Plus Bevacizumab in Advanced Solid Tumors
Angiogenesis, the development of new blood vessels, plays an important role in the disease development and tumor growth in many solid organ malignancies. Bevacizumab was the first anti-angiogenic drug to be approved in solid tumors and has shown advantageous activity with multiple tumor types. However, the responses from Bevacizumab are often transient due to the tumor's manipulative abilities to circumvent the usual pathways to find salvage pathways instead.
Nintedanib has demonstrated anti-tumor activity in non-squamous non-small cell lung cancer, colorectal cancer, ovarian cancer, and renal cell cancer. The combination of Bevacizumab and Nintedanib are being proposed to target the tumor's manipulation processes to generate alternate pathways for angiogenesis thus creating a potential benefit to delay tumor growth.
Read the detailed description
This is an open-label, phase I dose-escalation study of Nintedanib combined with standard-dose Bevacizumab for advanced solid tumors in which Bevacizumab has an indication. The primary endpoints will be safety and tolerability of the drug combination and a determination of recommended Phase II dose for Nintedanib in combination with standard dose Bevacizumab.
The first three patients will be treated with Nintedanib daily plus Bevacizumab on day one of each three week cycle. If there are no dose limiting toxicities, then three additional patients will be treated with the same drugs with Nintedanib at a slightly higher level. Finally, a third cohort of three patients will be dosed at an even higher level. Once the maximum tolerated dose of Nintedanib is reached, then an additional six patients will be treated at that dose in combination with Bevacizumab until disease progression or unacceptable toxicities.
- Conditions
- Renal Cell Carcinoma, Colorectal Adenocarcinoma, Non-squamous Non-small Cell Lung Cancer, Platinum-refractory Ovarian Carcinoma, Cervical Carcinoma
- Being tested
- Nintedanib, Bevacizumab
- Keywords
- advanced solid tumors, Nintedanib, Bevacizumab, dose escalation
- Medical subject headings
- Carcinoma, Renal Cell, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NintedanibDrug
Also called BIBF1120
Nintedanib will be given twice daily at either 150 mg or 200 mg.
BevacizumabDrug
Also called Avastin
Bevacizumab will be given at 15 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Nintedanib 150 mg + Bevacizumab 15 mg/kg | Experimental | The first three patients on study will be treated with 150 mg orally of Nintedanib two times daily plus 15 mg/kg of Bevacizumab administered intravenously on day one of each three week cycle.
If one dose limiting toxicity occurs in the first cohort, then three more patients will be treated at that same starting dose and assessed for toxicity after cycle two. If two or more patients have dose limiting toxicity, then dose escalation will end and the maximum tolerated dose will be reached. Receives: Drug: Nintedanib; Drug: Bevacizumab |
| Nintedanib 200 mg + Bevacizumab 15 mg/kg | Experimental | If no patients experience dose limiting toxicity, then three additional patients will be treated with 200 mg orally of Nintedanib two times daily plus 15 mg/kg of Bevacizumab administered intravenously on day one of each three week cycle. Receives: Drug: Nintedanib; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability
Adverse event reporting will be graded following the National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Measured: Initial dose of study drug until four weeks after the last dose or until death, whichever occurs first
Maximum tolerable dose of Nintedanib
The maximum dosage of drug that yields acceptable toxicity levels.
Measured: Baseline up to three years
Secondary outcomes (7)
Objective tumor response rate
Response will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Measured: up to 100 weeks
Progression-free survival
Progression-free survival is defined as the duration of time from start of treatment to the first documentation of tumor progression. Kaplan-Meier estimates will be used.
Measured: Baseline up to three years
Plasma level of vascular endothelial growth factor (VEGF)
Correlative analysis will be conducted using Chi-square tests and Spearman rank correlations. Differences between responders and non-responders will utilize the Kruskal-Wallis test.
Measured: Baseline up to two years
Plasma level of platelet-derived growth factor (PDGF)
Correlative analysis will be conducted using Chi-square tests and Spearman rank correlations. Differences between responders and non-responders will utilize the Kruskal-Wallis test.
Measured: Baseline up to two years
Plasma level of vascular endothelial growth factor and receptor (VEGF-R)
Correlative analysis will be conducted using Chi-square tests and Spearman rank correlations. Differences between responders and non-responders will utilize the Kruskal-Wallis test.
Measured: Baseline up to two years
Plasma level of phosphatidylinositol-glycan biosynthesis class F protein (PIGF)
Correlative analysis will be conducted using Chi-square tests and Spearman rank correlations. Differences between responders and non-responders will utilize the Kruskal-Wallis test.
Measured: Baseline up to two years
Plasma level of fibroblast growth factor (FGF)
Correlative analysis will be conducted using Chi-square tests and Spearman rank correlations. Differences between responders and non-responders will utilize the Kruskal-Wallis test.
Measured: Baseline up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study start9 Jun 2016
- Primary completion14 Apr 2018
- Study completion14 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Francisco Robert,MD, University of Alabama at Birmingham
- Investigators
- Francisco Robert, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835833
- Sponsor's protocol ID
- F160202011 (UAB 15108)
- Status last verified
- Jul 2018
- First submitted
- 7 Jul 2016
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paluri R, Madan A, Li P, Jones B, Saleh M, Jerome M, Miley D, Keef J, Robert F. Phase 1b trial of nintedanib in combination with bevacizumab in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2019 Mar;83(3):551-559. doi: 10.1007/s00280-018-3761-y. Epub 2019 Jan 2.
PubMed 30603797
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalation Study of Nintedanib Plus Bevacizumab in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02835833
- Acronym / sponsor ID
- F160202011 (UAB 15108)
- Conditions
- Renal Cell Carcinoma, Colorectal Adenocarcinoma, Non-squamous Non-small Cell Lung Cancer, Platinum-refractory Ovarian Carcinoma, Cervical Carcinoma
- Keywords
- advanced solid tumors, Nintedanib, Bevacizumab, dose escalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 9 Jun 2016 (actual)
- Primary completion
- 14 Apr 2018 (actual)
- Study completion
- 14 Jun 2018 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Angiogenesis, the development of new blood vessels, plays an important role in the disease development and tumor growth in many solid organ malignancies. Bevacizumab was the first anti-angiogenic drug to be approved in solid tumors and has shown advantageous activity with multiple tumor types. However, the responses from Bevacizumab are often transient due to the tumor's manipulative abilities to circumvent the usual pathways to find salvage pathways instead.
Nintedanib has demonstrated anti-tumor activity in non-squamous non-small cell lung cancer, colorectal cancer, ovarian cancer, and renal cell cancer. The combination of Bevacizumab and Nintedanib are being proposed to target the tumor's manipulation processes to generate alternate pathways for angiogenesis thus creating a potential benefit to delay tumor growth.
Detailed description
This is an open-label, phase I dose-escalation study of Nintedanib combined with standard-dose Bevacizumab for advanced solid tumors in which Bevacizumab has an indication. The primary endpoints will be safety and tolerability of the drug combination and a determination of recommended Phase II dose for Nintedanib in combination with standard dose Bevacizumab.
The first three patients will be treated with Nintedanib daily plus Bevacizumab on day one of each three week cycle. If there are no dose limiting toxicities, then three additional patients will be treated with the same drugs with Nintedanib at a slightly higher level. Finally, a third cohort of three patients will be dosed at an even higher level. Once the maximum tolerated dose of Nintedanib is reached, then an additional six patients will be treated at that dose in combination with Bevacizumab until disease progression or unacceptable toxicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nintedanib 150 mg + Bevacizumab 15 mg/kg | Experimental | Drug: Nintedanib, Drug: BevacizumabThe first three patients on study will be treated with 150 mg orally of Nintedanib two times daily plus 15 mg/kg of Bevacizumab administered intravenously on day one of each three week cycle. If one dose limiting toxicity occurs in the first cohort, then three more patients will be treated at that same starting dose and assessed for toxicity after cycle two. If two or more patients have dose limiting toxicity, then dose escalation will end and the maximum tolerated dose will be reached. |
| Nintedanib 200 mg + Bevacizumab 15 mg/kg | Experimental | Drug: Nintedanib, Drug: BevacizumabIf no patients experience dose limiting toxicity, then three additional patients will be treated with 200 mg orally of Nintedanib two times daily plus 15 mg/kg of Bevacizumab administered intravenously on day one of each three week cycle. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age >18
- Histologically proven advanced or metastatic solid cancer for which Bevacizumab has an indication: renal cell carcinoma, colorectal adenocarcinoma, non-squamous non-small cell lung cancer, platinum- refractory ovarian carcinoma, cervical carcinoma.
- Life expectancy at least 3 months
- ECOG performance status score 0-1
- Progression after at least first-line systemic therapy for metastatic disease
Key exclusion criteria (33 listed)
- Previous therapy with Bevacizumab is allowed, but patient who experienced serious dose-limiting toxicities while on prior Bevacizumab therapy are excluded
- Prior treatment with Nintedanib (BIBF1120). Known hypersensitivity to Nintedanib, peanut or soya or any other trial drug, their excipients or to contrast media
- Chemo-, hormone-, radio-(except for brain and extremities) or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug.
- Radiotherapy to the target lesion within the past 3 months prior to baseline imaging
- Persistence of clinically relevant therapy related toxicity from previous chemo and/or radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NintedanibAlso: BIBF1120Nintedanib will be given twice daily at either 150 mg or 200 mg. | Drug | Nintedanib 150 mg + Bevacizumab 15 mg/kg, Nintedanib 200 mg + Bevacizumab 15 mg/kg |
| BevacizumabAlso: AvastinBevacizumab will be given at 15 mg/kg | Drug | Nintedanib 150 mg + Bevacizumab 15 mg/kg, Nintedanib 200 mg + Bevacizumab 15 mg/kg |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Initial dose of study drug until four weeks after the last dose or until death, whichever occurs first
Adverse event reporting will be graded following the National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Maximum tolerable dose of Nintedanib
Time frame: Baseline up to three years
The maximum dosage of drug that yields acceptable toxicity levels.
7 secondary outcomes
Objective tumor response rate
Time frame: up to 100 weeks
Progression-free survival
Time frame: Baseline up to three years
Plasma level of vascular endothelial growth factor (VEGF)
Time frame: Baseline up to two years
Plasma level of platelet-derived growth factor (PDGF)
Time frame: Baseline up to two years
Plasma level of vascular endothelial growth factor and receptor (VEGF-R)
Time frame: Baseline up to two years
Plasma level of phosphatidylinositol-glycan biosynthesis class F protein (PIGF)
Time frame: Baseline up to two years
Plasma level of fibroblast growth factor (FGF)
Time frame: Baseline up to two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Derived from this study: PubMed 30603797Paluri R, Madan A, Li P, Jones B, Saleh M, Jerome M, Miley D, Keef J, Robert F. Phase 1b trial of nintedanib in combination with bevacizumab in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2019 Mar;83(3):551-559. doi: 10.1007/s00280-018-3761-y. Epub 2019 Jan 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Robert, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nintedanib and Bevacizumab in people with Renal Cell Carcinoma and Colorectal Adenocarcinoma, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events as a measure of safety and tolerability (time frame: Initial dose of study drug until four weeks after the last dose or until death, whichever occurs first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02835833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.