AzTrials
AzTrials

Urologic MalignanciesPhase 2NCT02232646

A Study of BBI503 in Adult Patients With Advanced Urologic Malignancies

A Phase 2 study testing BBI503 in people with Urologic Malignancies and Renal Cell Carcinoma, run by Sumitomo Pharma America, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This is an open label, multi-center, Phase II study of BBI503 administered to adult patients with selected advanced urologic malignancies. The primary objective of this study is to evaluate the disease control rate of patients with renal cell cancer and urothelial carcinoma treated with BBI503. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BBI503
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2017to 1 Aug 2018
Phase
Phase 2
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

  • Signed written informed consent
  • Histologically or cytologically confirmed renal cell cancer or urothelial carcinoma that is metastatic, unresectable, or recurrent.
  • ≥ 18 years of age
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last BBI503 dose
Show all 22Show fewer
  • Females of childbearing potential must have a negative serum pregnancy test
  • Alanine transaminase (ALT) ≤ 2.5 x the upper limit of normal (ULN), or ≤ 3.5 x ULN in the presence of primary or metastatic hepatic lesions
  • Hemoglobin (Hgb) ≥ 10 g/dl
  • Total bilirubin ≤ 1.5 x ULN
  • Creatinine ≤ 1.5 x ULN or creatinine clearance > 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
  • Absolute neutrophil count ≥ 1.5 x 10^9/L
  • Platelets ≥ 100 x 10^9/L
  • Prothrombin time (PT) ≤ 16 seconds and partial thromboplastin time (PTT) ≤ 1.5 x ULN
  • Life expectancy ≥ 3 months
  • A patient with renal cell carcinoma (RCC) must be classified into clear-cell or non-clear cell subtype, and must then meet the following criteria:
  • Patients with clear cell renal cancer must have received prior treatment with at least one line of standard systemic therapy which included treatment with a tyrosine kinase inhibitor; either alone or in combination. The patient must have had either progressive disease during treatment, or have had documented intolerance to first line tyrosine kinase inhibitor (TKI)-based therapy.
  • Patients with clear cell renal cancer who have received anti-cancer treatment beyond first-line TKI-based therapy may enroll.
  • Patients with clear cell renal cancer who have not received anti-cancer treatment beyond first-line TKI-based therapy may enroll only after discussing the potential risks and benefits of alternative treatment options, such as other currently available agents approved for treatment of patients with clear cell renal cancer.
  • Patients with non-clear cell RCC which is metastatic may enroll without having received prior treatment in the metastatic setting
  • A patient with urothelial carcinoma must also meet the following criteria:
  • Must have received at least one prior line of standard systemic cytotoxic therapy in the metastatic setting.

Who cannot join

  • Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 7 days of first dose of BBI503. Patients may begin BBI503 on a date determined by the investigator and medical monitor for the sponsor provided there is a minimum of 7 days since last receiving anti-cancer treatment, and that all prior treatment-related adverse events (AEs) have resolved or have been deemed irreversible.
  • Major surgery within 4 weeks prior to first dose (requiring general anesthesia and/or inpatient hospitalization for recovery).
  • Any known symptomatic or untreated brain metastases requiring increase of steroid dose within 2 weeks prior to starting on study. Patients with treated brain metastases must be stable for 4 weeks after completion of that treatment. Post-treatment image documentation of stability is required within 4 months of starting on study. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated.
  • Pregnant or breastfeeding
  • Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection)
  • Unable or unwilling to swallow BBI503 capsules daily
Show all 9Show fewer
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements (e.g. no reliable transportation).
  • Patients with a history of malignancies other than the tumor of interest except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 3 years.
  • Abnormal ECGs which are clinically significant such as QT prolongation - QTc > 480 msec, clinically significant cardiac enlargement or hypertrophy, new bundle branch block, or signs of active ischemia. Patients with evidence of prior infarction who are New York Heart Association (NYHA) functional class II, III, or IV are excluded, as are patients with marked arrhythmia such as Wolff Parkinson White pattern or complete atrioventricular (AV) dissociation.

About this study

Official title: A Phase II Clinical Study of BBI503 in Adult Patients With Advanced Urologic Malignancies

This is an open label, multi-center, Phase II study of BBI503 administered to adult patients with selected advanced urologic malignancies. The primary objective of this study is to evaluate the disease control rate of patients with renal cell cancer and urothelial carcinoma treated with BBI503.

Being tested
BBI503
Medical subject headings
Carcinoma, Renal Cell, Carcinoma, Transitional Cell

What participants receive

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

  • BBI503Drug

    Also called Amcasertib, BBI-503, BB503

    BBI503 will be administered orally, daily, in continuous 28-day cycles at a dose of 300 mg once daily.

Study groups in NCT02232646
Study groupRoleWhat they receive
BBI503ExperimentalNot described
Receives: Drug: BBI503

What is being measured

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

  1. Disease Control Rate (DCR)

    Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.

    Measured: 8 weeks

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

    Defined as the proportion of patients with a documented complete response and partial response (CR + PR) based on RECIST 1.1.

    Measured: 8 weeks

  2. Progression Free Survival (PFS)

    Defined as the time from enrollment to the first objective documentation of disease progression or death due to any cause.

    Measured: 24 months

  3. Overall Survival (OS)

    Defined as the time from enrollment to death due to any cause.

    Measured: 24 months

  4. Number of Patients with Adverse Events

    All patients who have received at least one dose of BBI608 will be included in the safety analysis. The incidence of adverse events will be summarized by type of adverse event and severity.

    Measured: 24 months

  5. Pharmacodynamics (biomarkers) of BBI503 when tumor biopsy is possible

    Measured: baseline, 4 weeks

Timeline

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

  1. First posted5 Sep 2014 (estimated)
  2. Study startJan 2017
  3. Primary completion1 Aug 2018
  4. Study completion1 Aug 2018

Why it stopped: Low feasibility

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02232646
Sponsor's protocol ID
BBI503-205a
Status last verified
Nov 2023
First submitted
2 Sep 2014
Last updated
14 Nov 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BBI503 in people with Urologic Malignancies and Renal Cell Carcinoma, run by Sumitomo Pharma America, Inc..

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 22 inclusion and 9 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: withdrawn, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

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 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Disease Control Rate (DCR) (time frame: 8 weeks). 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 NCT02232646.

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 14 Nov 2023.

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