Advanced Solid TumorsPhase 1/2NCT01781429

Phase I Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of BVD-523 in Patients With Advanced Malignancies

A Phase 1/2 study testing BVD-523 in people with Advanced Solid Tumors, run by BioMed Valley Discoveries, Inc at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This open-label, multi-center Phase 1/2 study will assess the safety, pharmacokinetics, and pharmacodynamics of escalating doses of BVD-523 in patients with advanced malignancies. The study also seeks to demonstrate target modulation and early signs of clinical response in select patient populations. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumors
What is being tested?: BVD-523
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 136 participants
Where: 9 sitesUnited States
Study dates: Mar 2013to Sep 2018
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with metastatic or advanced-stage malignant tumor. Patients may have received up to 2 prior lines of chemotherapy for their metastatic disease
ECOG score of 0 or 1
Predicted life expectancy of ≥ 3 months
Adequate bone marrow, liver and renal function renal function
Adequate cardiac function
For women: Negative pregnancy test for females of child-bearing potential; must be surgically sterile, postmenopausal, or compliant with a contraceptive regimen during and for 3 months after the treatment period

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For men: Must be surgically sterile, or compliant with a contraceptive regimen during and for 3 months after the treatment period
For Part 2 of the Study only, patients must have measurable disease by RECIST 1.1 and be in one of the the groups below. Patients in groups 1, 2, 4, 5 and 6 may not have been previously treated with BRAF and/or MEK inhibitors
Group 1: Patients with BRAF mutated cancer, except those with colorectal or non-small cell lung cancers
Group 2: Patients with BRAF mutated colorectal cancer
Group 3: Patients with BRAF mutated melanoma who have progressed on, or are refractory to BRAF and/or MEK inhibitors
Group 4: Patients with NRAS mutated melanoma
Group 5: Patients with MEK mutated cancer
Group 6: Patients with BRAF mutated non-small cell lung cancer
Group 7: Patients with ERK mutated cancer

Who cannot join

Gastrointestinal condition which could impair absorption of study medication
Uncontrolled or severe intercurrent medical condition
Known uncontrolled brain metastases. Stable brain metastases either treated or being treated with a stable dose of steroids/anticonvulsants
Any cancer-directed therapy (chemotherapy, radiotherapy, hormonal therapy, biologic or immunotherapy, etc.) within 28 days or 5 half-lives, whichever is shorter
Major surgery within 4 weeks prior to first dose
Any use of an investigational drug within 28 days or 5 half-lives (whichever is shorter) prior to the first dose of BVD-523.

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Pregnant or breast-feeding women
Any evidence of serious active infections
Any important medical illness or abnormal laboratory finding that would increase the risk of participating in this study
A history or current evidence/risk of retinal vein occlusion or central serous retinopathy
Concurrent therapy with any other investigational agent
Concomitant malignancies or previous malignancies with less than 2 years disease-free interval at the time of enrollment

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114
UT M.D Anderson Cancer Center
Houston, Texas, 77030
UCLA Med-Hematology & Oncology
Los Angeles, California, 90095
Sarah Cannon Research Institute Hospital at Vanderbilt
Nashville, Tennessee, 37203
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37212
Yale Cancer Center
New Haven, Connecticut, 06520
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Florida Cancer Specialists and Research Group (Sarah Cannon Research Institute)
Sarasota, Florida, 34232
Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Read the detailed description

The study is being performed to assess the safety and tolerability of BVD-523

In Part 1 of the study, an accelerated dose escalation plan will be used to establish dose limiting toxicities, maximum tolerated dose, and the recommended Phase 2 dose.

In Part 2 of the study, additional patients with particular tumor types and/or cancers harboring specific genetic mutations will be recruited for treatment at the Recommended Phase 2 Dose. Patients may also be assessed pharmacodynamic measures in healthy or malignant tissues, using biomarker assays for phosphorylation, cytotoxic or cytostatic measures.

Conditions: Advanced Solid Tumors
Being tested: BVD-523

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BVD-523Drug
Oral, multiple escalating doses, twice daily, for 21 days in each treatment cycle

Study groups in NCT01781429
Study group	Role	What they receive
BVD-523	Experimental	Not described Receives: Drug: BVD-523

What is being measured

The primary outcome is the main question the study is designed to answer.

Determination of Recommended Phase 2 Dose (RP2D) of BVD-523 by Dose-limiting Toxicities (DLT).
DLT is defined as any BVD-523 related toxicity in the first 21 days of treatment that results in:
1. ≥Grade 4 hematologic toxicity for >1 day;
2. Grade 3 hematologic toxicity with complications e.g., thrombocytopenia with bleeding;
3. ≥Grade 3 non-hematologic toxicity, except untreated nausea, vomiting, constipation, pain and rash (these become DLTs if the adverse event (AE) persists despite adequate treatment), a doubling of aspartate transaminase (AST)/alanine transaminase (ALT) in patients with grade 2 ALT/AST at baseline;
4. A treatment interruption exceeding 5 days (or an interruption exceeding 7 days for rash, despite adequate treatment) in Cycle 1 (or inability to begin Cycle 2 for > 7 days) due to BVD-523-related toxicity.
Measured: As indicated by safety and tolerability during study conduct; ~42 months

Secondary outcomes (2)

Characterization of the Time Versus Plasma Concentration Profiles of BVD-523 and Selected Metabolites.
Data provided is for BVD-523.
Measured: Samples will be collected on day 1 and day 15 of Cycle 1
Clinical Evidence of Tumor Response Assessed by Physical or Radiological Exam.
At enrollment, all study patients had metastatic or advanced-stage malignant tumor for which no curative therapy was known to exist. Patients entering Part 2 additionally had to have measurable disease by RECIST version 1.1. Data shown is best response.
Measured: Patients will be evaluated at baseline & at periodic follow-up visits through the time their participation in the study is completion. The best responses presented occurred at different time points for each patient.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Sep 2018

First posted1 Feb 2013 (estimated)
Study startMar 2013
Primary completionFeb 2018
Study completionSep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 136 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01781429
Sponsor's protocol ID: BVD-523-01
Other IDs: BVD-523-01
Status last verified: Mar 2020
First submitted: 28 Jan 2013
Last updated: 20 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Wu J, Liu D, Offin M, Lezcano C, Torrisi JM, Brownstein S, Hyman DM, Gounder MM, Abida W, Drilon A, Harding JJ, Sullivan RJ, Janku F, Welsch D, Varterasian M, Groover A, Li BT, Lacouture ME. Characterization and management of ERK inhibitor associated dermatologic adverse events: analysis from a nonrandomized trial of ulixertinib for advanced cancers. Invest New Drugs. 2021 Jun;39(3):785-795. doi: 10.1007/s10637-020-01035-9. Epub 2021 Jan 3.
PubMed 33389388
Mendzelevski B, Ferber G, Janku F, Li BT, Sullivan RJ, Welsch D, Chi W, Jackson J, Weng O, Sager PT. Effect of ulixertinib, a novel ERK1/2 inhibitor, on the QT/QTc interval in patients with advanced solid tumor malignancies. Cancer Chemother Pharmacol. 2018 Jun;81(6):1129-1141. doi: 10.1007/s00280-018-3564-1. Epub 2018 Mar 30.
PubMed 29603015
Germann UA, Furey BF, Markland W, Hoover RR, Aronov AM, Roix JJ, Hale M, Boucher DM, Sorrell DA, Martinez-Botella G, Fitzgibbon M, Shapiro P, Wick MJ, Samadani R, Meshaw K, Groover A, DeCrescenzo G, Namchuk M, Emery CM, Saha S, Welsch DJ. Targeting the MAPK Signaling Pathway in Cancer: Promising Preclinical Activity with the Novel Selective ERK1/2 Inhibitor BVD-523 (Ulixertinib). Mol Cancer Ther. 2017 Nov;16(11):2351-2363. doi: 10.1158/1535-7163.MCT-17-0456. Epub 2017 Sep 22.
PubMed 28939558

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
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Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of BVD-523 in Patients With Advanced Malignancies
ClinicalTrials.gov ID: NCT01781429
Acronym / sponsor ID: BVD-523-01
Conditions: Advanced Solid Tumors
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 136 participants (actual)
Lead sponsor: BioMed Valley Discoveries, IncIndustry (pharma, biotech, devices)
Study start: Mar 2013 (actual)
Primary completion: Feb 2018 (actual)
Study completion: Sep 2018 (actual)
First posted: 1 Feb 2013 (estimated)
Results: Posted 20 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study is being performed to assess the safety and tolerability of BVD-523

In Part 1 of the study, an accelerated dose escalation plan will be used to establish dose limiting toxicities, maximum tolerated dose, and the recommended Phase 2 dose.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BVD-523	Experimental	Drug: BVD-523

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Patients with metastatic or advanced-stage malignant tumor. Patients may have received up to 2 prior lines of chemotherapy for their metastatic disease
ECOG score of 0 or 1
Predicted life expectancy of ≥ 3 months
Adequate bone marrow, liver and renal function renal function
Adequate cardiac function

Key exclusion criteria (12 listed)

Gastrointestinal condition which could impair absorption of study medication
Uncontrolled or severe intercurrent medical condition
Known uncontrolled brain metastases. Stable brain metastases either treated or being treated with a stable dose of steroids/anticonvulsants
Any cancer-directed therapy (chemotherapy, radiotherapy, hormonal therapy, biologic or immunotherapy, etc.) within 28 days or 5 half-lives, whichever is shorter
Major surgery within 4 weeks prior to first dose

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
BVD-523Oral, multiple escalating doses, twice daily, for 21 days in each treatment cycle	Drug	BVD-523

Primary outcome

Determination of Recommended Phase 2 Dose (RP2D) of BVD-523 by Dose-limiting Toxicities (DLT).
Time frame: As indicated by safety and tolerability during study conduct; ~42 months
DLT is defined as any BVD-523 related toxicity in the first 21 days of treatment that results in: 1. ≥Grade 4 hematologic toxicity for >1 day; 2. Grade 3 hematologic toxicity with complications e.g., thrombocytopenia with bleeding; 3. ≥Grade 3 non-hematologic toxicity, except untreated nausea, vomiting, constipation, pain and rash (these become DLTs if the adverse event (AE) persists despite adequate treatment), a doubling of aspartate transaminase (AST)/alanine transaminase (ALT) in patients with grade 2 ALT/AST at baseline; 4. A treatment interruption exceeding 5 days (or an interruption exceeding 7 days for rash, despite adequate treatment) in Cycle 1 (or inability to begin Cycle 2 for > 7 days) due to BVD-523-related toxicity.

2 secondary outcomes

Characterization of the Time Versus Plasma Concentration Profiles of BVD-523 and Selected Metabolites.
Time frame: Samples will be collected on day 1 and day 15 of Cycle 1
Clinical Evidence of Tumor Response Assessed by Physical or Radiological Exam.
Time frame: Patients will be evaluated at baseline & at periodic follow-up visits through the time their participation in the study is completion. The best responses presented occurred at different time points for each patient.

Results and safety

Results posted to the registry on 20 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose-escalation 10mg b.i.d. Cohort	1	0
Dose-escalation 20mg b.i.d. Cohort	1	0
Dose-escalation 40mg b.i.d. Cohort	1	0
Dose-escalation 75mg b.i.d. Cohort	1	0
Dose-escalation 150mg b.i.d. Cohort	1	0
Dose-escalation 300mg b.i.d. Cohort	4	0
Dose-escalation 600mg b.i.d. Cohort	7	0
Dose-escalation 750mg b.i.d. Cohort	4	0
Dose-escalation 900mg b.i.d. Cohort	7	0
Cohort-expansion Group 1	24	0
Cohort-expansion Group 2	18	0
Cohort-expansion Group 3	21	0
Cohort-expansion Group 4	22	0
Cohort-expansion Group 5	8	0
Cohort-expansion Group 6	16	0
Cohort-expansion Group 7	0	0

Primary outcome: Determination of Recommended Phase 2 Dose (RP2D) of BVD-523 by Dose-limiting Toxicities (DLT).

Time frame: As indicated by safety and tolerability during study conduct; ~42 months. Count of participants. Unit: Participants

Measure	Dose-escalation 10mg b.i.d. Cohort n = 1	Dose-escalation 20mg b.i.d. Cohort n = 1	Dose-escalation 40mg b.i.d. Cohort n = 1	Dose-escalation 75mg b.i.d. Cohort n = 1	Dose-escalation 150mg b.i.d. Cohort n = 1	Dose-escalation 300mg b.i.d. Cohort n = 4	Dose-escalation 600mg b.i.d. Cohort n = 7	Dose-escalation 750mg b.i.d. Cohort n = 4	Dose-escalation 900mg b.i.d. Cohort n = 7
Any DLT: Yes	0	0	0	0	0	0	1	2	2
Any DLT: No	1	1	1	1	1	4	6	2	5
Grade 3 Hematologic Toxicity with Complications: Yes	0	0	0	0	0	0	0	1	2
Grade 3 Hematologic Toxicity with Complications: No	1	1	1	1	1	4	7	3	5
≥Grade 3 Non-Hematologic Toxicity: Yes	0	0	0	0	0	0	1	2	2
≥Grade 3 Non-Hematologic Toxicity: No	1	1	1	1	1	4	6	2	5

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The reporting period of an AE began from the time that the patient provided informed consent through and including 30 calendar days after the last administration of BVD-523 (or at the time when a patient begins a new anti-cancer therapy). Anticipated fluctuations of preexisting conditions, including the disease under study that did not represent a clinically significant exacerbation or worsening, did not need to be considered AEs. AEs were collected/assessed at each study visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dose-escalation 10mg b.i.d. Cohort	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Dose-escalation 20mg b.i.d. Cohort	1 of 1 (100%)	1 of 1 (100%)	0 of 1
Dose-escalation 40mg b.i.d. Cohort	1 of 1 (100%)	1 of 1 (100%)	0 of 1
Dose-escalation 75mg b.i.d. Cohort	1 of 1 (100%)	1 of 1 (100%)	0 of 1
Dose-escalation 150mg b.i.d. Cohort	1 of 1 (100%)	1 of 1 (100%)	0 of 1
Dose-escalation 300mg b.i.d. Cohort	2 of 4 (50%)	4 of 4 (100%)	0 of 4
Dose-escalation 600mg b.i.d. Cohort	2 of 7 (28.6%)	7 of 7 (100%)	0 of 7
Dose-escalation 750mg b.i.d. Cohort	1 of 4 (25%)	4 of 4 (100%)	0 of 4
Dose-escalation 900mg b.i.d. Cohort	5 of 7 (71.4%)	7 of 7 (100%)	0 of 7
Cohort-expansion	57 of 108 (52.8%)	107 of 108 (99.1%)	3 of 108

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33389388Wu J, Liu D, Offin M, Lezcano C, Torrisi JM, Brownstein S, Hyman DM, Gounder MM, Abida W, Drilon A, Harding JJ, Sullivan RJ, Janku F, Welsch D, Varterasian M, Groover A, Li BT, Lacouture ME. Characterization and management of ERK inhibitor associated dermatologic adverse events: analysis from a nonrandomized trial of ulixertinib for advanced cancers. Invest New Drugs. 2021 Jun;39(3):785-795. doi: 10.1007/s10637-020-01035-9. Epub 2021 Jan 3.
Derived from this study: PubMed 29603015Mendzelevski B, Ferber G, Janku F, Li BT, Sullivan RJ, Welsch D, Chi W, Jackson J, Weng O, Sager PT. Effect of ulixertinib, a novel ERK1/2 inhibitor, on the QT/QTc interval in patients with advanced solid tumor malignancies. Cancer Chemother Pharmacol. 2018 Jun;81(6):1129-1141. doi: 10.1007/s00280-018-3564-1. Epub 2018 Mar 30.
Derived from this study: PubMed 28939558Germann UA, Furey BF, Markland W, Hoover RR, Aronov AM, Roix JJ, Hale M, Boucher DM, Sorrell DA, Martinez-Botella G, Fitzgibbon M, Shapiro P, Wick MJ, Samadani R, Meshaw K, Groover A, DeCrescenzo G, Namchuk M, Emery CM, Saha S, Welsch DJ. Targeting the MAPK Signaling Pathway in Cancer: Promising Preclinical Activity with the Novel Selective ERK1/2 Inhibitor BVD-523 (Ulixertinib). Mol Cancer Ther. 2017 Nov;16(11):2351-2363. doi: 10.1158/1535-7163.MCT-17-0456. Epub 2017 Sep 22.

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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.

The record lists no contact. Use the official record to reach the sponsor.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BVD-523 in people with Advanced Solid Tumors, run by BioMed Valley Discoveries, Inc at 9 sites 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 15 inclusion and 12 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 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Determination of Recommended Phase 2 Dose (RP2D) of BVD-523 by Dose-limiting Toxicities (DLT). (time frame: As indicated by safety and tolerability during study conduct; ~42 months). 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 NCT01781429, which also lists 3 linked publications.

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 20 Mar 2020.