Study of Paclitaxel in Combination With BOS172722 in Patients With Advanced Nonhaematologic Malignancies

April 14, 2021 updated by: Boston Pharmaceuticals

A Phase 1/1b Study of Paclitaxel in Combination With BOS172722, a Monopolar Spindle 1 Kinase Inhibitor, in Patients With Advanced Nonhaematologic Malignancies

This study will be conducted to assess the safety and tolerability of BOS172722 when administered as monotherapy and in combination with paclitaxel in participants with advanced nonhaematologic malignancies and also to establish the maximum tolerated dose and recommended Phase 2 dose of BOS172722 in combination with paclitaxel in those participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom
        • Addenbrooks Hospital
      • Edinburgh, United Kingdom
        • Edinburgh Cancer Centre - Western General Hospital
      • London, United Kingdom, SM2 5NG
        • Royal Marsden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

  • For Part A only, histopathologically confirmed diagnosis of an advanced nonhaematologic malignancy
  • For Part B only, histopathologically confirmed diagnosis of triple-negative breast cancer
  • No standard curative treatment or has declined standard therapy
  • Eastern Cooperative Oncology Group performance status 0 or 1, measured within 72 hours before the first BOS172722 or paclitaxel dose
  • Predicted life expectancy of ≥ 3 months
  • Adequate renal function (creatinine ≤ 1.5 × upper limit of normal [ULN] or glomerular filtration rate ≥ 50 milliliters per minute [mL/min])

  • Adequate hepatic function:

    • Total bilirubin ≤ 1.5 × ULN
    • Aspartate transaminase ≤ 3 × ULN (or ≤ 5 × ULN if due to liver involvement by tumor)
    • Alanine transaminase ≤ 3 × ULN (or ≤ 5 × ULN if due to liver involvement by tumor)

  • Adequate bone marrow function:

    • Hemoglobin ≥ 9.0 grams per deciliter (g/dL)
    • Platelet count ≥ 100 × 10^9 cells per liter (cells/L)
    • Absolute neutrophil count ≥ 1.5 × 10^9 cells/L
  • Mean corrected QT interval as calculated by the Fridericia correction formula < 470 milliseconds
  • Willingness to use adequate contraceptive methods
  • Capable of giving signed informed consent
  • Willingness to avoid direct sunlight and the use of tanning equipment during the study and for at least 30 days after the last BOS172722 dose

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • For Part A combination cohorts and Part B: a history of hypersensitivity to paclitaxel
  • Persistent clinically significant toxicity from prior chemotherapy > Grade 1, excluding alopecia
  • Unable to swallow oral capsules
  • Gastrointestinal (GI) condition which could interfere significantly with the absorption of study medication
  • History of upper GI bleeding, ulceration, or perforation within 6 months before the first or paclitaxel BOS172722 dose
  • Uncontrolled or severe concurrent medical condition (including uncontrolled brain metastases). (Stable brain metastases either treated or being treated with a stable dose of steroids/anticonvulsants, with no dose change within 28 days before the first BOS172722 or paclitaxel dose, will be allowed.)
  • History of stroke or cerebrovascular accident within 3 months before the first BOS172722 or paclitaxel dose
  • Any evidence of serious active infection
  • Uncontrolled or severe cardiovascular disease, including myocardial infarct or unstable angina within 6 months before the first BOS172722 or paclitaxel dose, New York Heart Association Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, or cardiac amyloidosis
  • Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
  • Known infection with Human Immunodeficiency Virus or hepatitis A, B, or C (testing not required)
  • Major surgery within 28 days before the first BOS172722 or paclitaxel dose
  • Pregnant or breastfeeding
  • Active treatment for a secondary malignancy
  • Cancer-directed therapy (chemo-, radio-, immuno-, biologic, or hormonal therapy with the exception of luteinizing hormone-releasing hormone agonists/antagonists, receptor activator of nuclear factor kappa-B ligand inhibitors, and bisphosphonates) within 21 days or 5 half-lives, whichever is longer, before the first BOS172722 or paclitaxel dose (Palliative radiotherapy is allowed before initiating study treatment if any associated toxicity resolved to ≤ Grade 1.)
  • Use of a medication known to be a strong or moderate inhibitor or inducer of CYP3A4 within 14 days before the first BOS172722 or paclitaxel dose
  • Use of a medication known to be a substrate of CYP3A4 and to have a narrow therapeutic range within 14 days before the first BOS172722 or paclitaxel dose
  • Consumption of grapefruit or Seville oranges (including juice, marmalade, etc.) within 14 days before the first BOS172722 or paclitaxel dose

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A: Monotherapy (BOS172722)
BOS172722 will be administered on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycles in participants with histopathologically confirmed advanced nonhaematologic malignancies.
Drug: BOS172722
Oral capsules
Experimental: Part A: Combination therapy (BOS172722 + Paclitaxel)
BOS172722 will be administered on Cycle 0 Day 1 and on Days 1, 2, 8, 9, 15, and 16 in Cycle 1 and subsequent 28-day cycles in participants with histopathologically confirmed advanced nonhaematologic malignancies. The participants will also receive 80 milligrams per meters squared (mg/m^2) paclitaxel as an intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle. During dose escalation, further exploration of the treatment schedule for the BOS172722-paclitaxel combination will be initiated. In such combination cohorts, BOS172722 will be administered with paclitaxel on Days 1, 8, and 15 only of each treatment cycle (except for Cycle 2 Day1), and will not be administered on Day 2, 9, and 16. These alternative schedules will be explored to further characterize the pharmacokinetics and tolerability of such a dosing regimen.
Drug: Paclitaxel
IV infusion
Drug: BOS172722
Oral capsules
Experimental: Part B: Combination therapy (BOS172722 + Paclitaxel)
Participants with triple-negative breast cancer will be treated with oral BOS172722 at the recommended Phase 2 dose (RP2D) established in Part A on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle and IV paclitaxel at 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle.
Drug: Paclitaxel
IV infusion
Drug: BOS172722
Oral capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (AEs)
Time Frame: a minimum of approximately 3 months
An AE is any untoward medical occurrence and does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product (IP), whether or not related to the IP. AEs include pre-existing conditions that worsen.
a minimum of approximately 3 months
Number of participants with a dose-limiting toxicity (DLT)
Time Frame: Cycle 1 (28 days)
A DLT is defined as any toxicity attributable to BOS172722 that occurs before the end of Cycle 1.
Cycle 1 (28 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part A Monotherapy: Plasma concentration of BOS172722 measured over 24 hours when administered alone
Time Frame: Cycle 1: Day 1
The plasma concentration of BOS172722 when administered as monotherapy will be characterized
Cycle 1: Day 1
Part A Combination: Plasma concentration of BOS172722 and paclitaxel measured over 24 hours when administered either individually or in combination
Time Frame: Cycle 0: Day 1; Cycle 1: Day 1; Cycle 2: Day 1
The plasma concentration of BOS172722 and paclitaxel will be characterized.
Cycle 0: Day 1; Cycle 1: Day 1; Cycle 2: Day 1
Part B Expansion: Plasma concentration of BOS172722 and paclitaxel measured over 24 hours when administered in combination
Time Frame: Cycle 1: Days 1 and 8 or 15
The plasma concentration of BOS172722 and paclitaxel will be characterized.
Cycle 1: Days 1 and 8 or 15
Objective response rate (ORR)
Time Frame: a minimum of approximately 3 months
ORR is defined as the percentage of participants achieving the best overall response of confirmed partial response (PR) or complete response (CR), as determined by investigator review. Responses are assessed by the Investigators using Response Evaluation Criteria in Solid Tumours (RECIST) guideline version 1.1.
a minimum of approximately 3 months
Duration of response (DOR)
Time Frame: a minimum of approximately 3 months
DOR is defined as the time from documentation of tumor response to disease progression. Responses are assessed by the Investigators using RECIST guideline version 1.1.
a minimum of approximately 3 months
Time to response (TTR)
Time Frame: a minimum of approximately 3 months
TTR is defined as the time from the start of treatment to the first objective tumor response observed for participants who achieved a CR or PR. Responses are assessed by the Investigators using RECIST guideline version 1.1.
a minimum of approximately 3 months
Time to progression on study
Time Frame: a minimum of approximately 3 months
Time to progression is defined as the time from treatment until objective tumor progression. This does not include deaths. Responses are assessed by the Investigators using RECIST guideline version 1.1.
a minimum of approximately 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 16, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BOS172722-01
  • 2017-001749-29 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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