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A Study to Assess the Safety and Tolerability of Adavosertib for Patients With Advanced Solid Tumours

Sponsor
AstraZeneca (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04949425
Collaborator
Parexel (Industry)
78
Enrollment
15
Locations
1
Arm
26.1
Anticipated Duration (Months)
5.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to allow continued adavosertib treatment of patients with advanced solid tumours participating in the adavosertib clinical pharmacology studies and to assess the continued safety and tolerability of adavosertib for patients enrolled in adavosertib clinical pharmacology studies (hereafter referred to as the 'parent studies') who continue to use the therapy

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Patients will be screened within 14 days of Day 1 of the treatment period. During screening, patients will undergo an appropriate washout period after the last dose of adavosertib in the parent clinical pharmacology study before receiving the first dose of adavosertib in this study.

Patients will continue to receive adavosertib as long as they are benefiting from treatment in the investigator's opinion and do not meet any other discontinuation criteria.

The number of patients who enroll is dependent on the number of patients who complete the parent studies, and who tolerate adavosertib in the parent study.

The anticipated total duration of the study is approximately 3 years.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Non-randomised, Multicentre Study to Allow Continued Access to and Assess the Safety and Tolerability of Adavosertib for Patients With Advanced Solid Tumours Enrolled in Adavosertib Clinical Pharmacology Studies
Actual Study Start Date :
Sep 13, 2021
Anticipated Primary Completion Date :
Nov 16, 2023
Anticipated Study Completion Date :
Nov 16, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients with advanced solid tumours

Patients with advanced solid tumours will receive Adavosertib once daily for 5 days followed by 2 days off for 2 weeks out of a 21-day cycle.

Drug: Adavosertib
Patients will receive Adavosertib orally.
Other Names:
  • AZD1775

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with serious and non-serious adverse events [From screening to safety follow-up (30 days after last dose)]

      Assessment of the safety and tolerability of adavosertib following oral dosing of the capsule formulation in patients with advanced solid tumours

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 130 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, for which standard therapy does not exist or has proven ineffective or intolerable.

    2. Participant has completed one of the parent adavosertib clinical pharmacology studies (i.e., D601HC00004, D601HC00006) and is suitable for continued treatment with adavosertib.

    3. Eastern Cooperative Oncology Group performance status score of 0 to 1.

    4. Life expectancy ≥ 12 weeks.

    5. Participants must have normal organ and marrow function at baseline, within 7 days prior to study drug administration.

    6. Males and females of childbearing potential who agree to use contraceptive measures should be consistent with clinical study protocol.

    Exclusion Criteria:
    1. Persistent toxicities (Common Terminology Criteria for Adverse Events [CTCAE] Grade >
    1. caused by previous anticancer therapy, excluding alopecia and CTCAE Grade 2 peripheral neuropathy.

    1. Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of adavosertib.

    2. Any significant cardiac diseases currently or within the last 6 months such as:

    3. unstable angina pectoris

    4. acute myocardial infarction, congestive heart failure

    5. conduction abnormality not controlled with pacemaker or medication

    6. significant ventricular or supraventricular arrhythmias

    7. Any of the following: History or current evidence of congenital long QT syndrome; concomitant medications known to prolong QT interval or history of medication-related QT prolongation.

    8. Known to have tested positive for human immunodeficiency virus or active tuberculosis infection.

    9. Known active hepatitis infection, positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening.

    10. Any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant, active infections, and active bleeding diseases) which prohibit participating in the study.

    11. Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.

    12. Use of an anti-cancer treatment drug ≤ 21 days (≤ 6 weeks for nitroureas or mitomycin

    1. or use of an investigational product within 5 half-lives prior to the first dose of adavosertib.

    1. Patient uses drugs that are sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or are moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued 2 weeks or 5 halflives (whichever is longer) prior to Day 1 of dosing.

    2. Receipt of live virus and live bacterial vaccines whilst the patient is receiving the study intervention and during the 30-day follow-up period. Inactivated vaccines are permitted.

    3. Currently pregnant (confirmed with positive pregnancy test) or breast feeding.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Newnan Georgia United States 30265
    2 Research Site Lebanon New Hampshire United States 03756
    3 Research Site Portland Oregon United States 97213
    4 Research Site Austin Texas United States 78758
    5 Research Site Dallas Texas United States 75230
    6 Research Site Barcelona Spain 8023
    7 Research Site Madrid Spain 28029
    8 Research Site Madrid Spain 28031
    9 Research Site Madrid Spain 28034
    10 Research Site Madrid Spain 28040
    11 Research Site Madrid Spain 28041
    12 Research Site Malaga Spain 29010
    13 Research Site Pozuelo de Alarcon Spain 28223
    14 Research Site London United Kingdom W12 0HS
    15 Research Site Manchester United Kingdom M20 4BX

    Sponsors and Collaborators

    • AstraZeneca
    • Parexel

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT04949425
    Other Study ID Numbers:
    • D601HC00009
    First Posted:
    Jul 2, 2021
    Last Update Posted:
    Jun 13, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AstraZeneca
    Advanced Solid Tumours
    Continued Access
    Parent Studies
    Additional relevant MeSH terms:
    Neoplasms
    Adavosertib

    Study Results

    No Results Posted as of Jun 13, 2022