AzTrials
AzTrials

Advanced Nonhaematologic MalignanciesPhase 1NCT03328494

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

A Phase 1 study testing BOS172722 and Paclitaxel in people with Advanced Nonhaematologic Malignancies, run by Boston Pharmaceuticals at 3 sites in United Kingdom.

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 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Nonhaematologic Malignancies
What is being tested?
BOS172722 and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
3 sitesUnited Kingdom
Study dates
13 Oct 2017to 16 Mar 2021
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

  • Addenbrooks Hospital

    Cambridge

  • Edinburgh Cancer Centre - Western General Hospital

    Edinburgh

  • Royal Marsden

    London, SM2 5NG

Other trials in United Kingdom

About this study

Official title: 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.

Being tested
BOS172722, Paclitaxel
Keywords
Paclitaxel, BOS172722, triple-negative breast cancer
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

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

  • BOS172722Drug

    Oral capsules

  • PaclitaxelDrug

    IV infusion

Study groups in NCT03328494
Study groupRoleWhat they receive
Part A: Monotherapy (BOS172722)ExperimentalBOS172722 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.
Receives: Drug: BOS172722
Part A: Combination therapy (BOS172722 + Paclitaxel)ExperimentalBOS172722 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.
Receives: Drug: BOS172722; Drug: Paclitaxel
Part B: Combination therapy (BOS172722 + Paclitaxel)ExperimentalParticipants 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.
Receives: Drug: BOS172722; Drug: Paclitaxel

What is being measured

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

  1. Incidence of adverse events (AEs)

    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.

    Measured: a minimum of approximately 3 months

  2. Number of participants with a dose-limiting toxicity (DLT)

    A DLT is defined as any toxicity attributable to BOS172722 that occurs before the end of Cycle 1.

    Measured: Cycle 1 (28 days)

Secondary outcomes (7)

  1. Part A Monotherapy: Plasma concentration of BOS172722 measured over 24 hours when administered alone

    The plasma concentration of BOS172722 when administered as monotherapy will be characterized

    Measured: Cycle 1: Day 1

  2. Part A Combination: Plasma concentration of BOS172722 and paclitaxel measured over 24 hours when administered either individually or in combination

    The plasma concentration of BOS172722 and paclitaxel will be characterized.

    Measured: Cycle 0: Day 1; Cycle 1: Day 1; Cycle 2: Day 1

  3. Part B Expansion: Plasma concentration of BOS172722 and paclitaxel measured over 24 hours when administered in combination

    The plasma concentration of BOS172722 and paclitaxel will be characterized.

    Measured: Cycle 1: Days 1 and 8 or 15

  4. Objective response rate (ORR)

    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.

    Measured: a minimum of approximately 3 months

  5. Duration of response (DOR)

    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.

    Measured: a minimum of approximately 3 months

  6. Time to response (TTR)

    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.

    Measured: a minimum of approximately 3 months

  7. Time to progression on study

    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.

    Measured: a minimum of approximately 3 months

Timeline

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

  1. First posted1 Nov 2017
  2. Study start13 Oct 2017
  3. Primary completion16 Mar 2021
  4. Study completion16 Mar 2021

Resources

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
Sequential
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03328494
Sponsor's protocol ID
BOS172722-01
Other IDs
2017-001749-29, 2017
Status last verified
Apr 2021
First submitted
30 Oct 2017
Last updated
15 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BOS172722 and Paclitaxel in people with Advanced Nonhaematologic Malignancies, run by Boston Pharmaceuticals at 3 sites in United Kingdom.

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 19 inclusion and 19 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 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. 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?

Incidence of adverse events (AEs) (time frame: a minimum of approximately 3 months). 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 NCT03328494.

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 15 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in