A study to assess the safety and tolerability of adavosertib for patients with advanced solid tumours

Study identifier:D601HC00009

ClinicalTrials.gov identifier:NCT04949425

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

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

Medical condition

Advanced Solid Tumours

Phase

Phase 1

Healthy volunteers

Study drug

Adavosertib

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 13 Sept 2021

Primary Completion Date: 12 Apr 2022

Study Completion Date: 12 Apr 2022

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2023 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria

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 > 2) caused by previous anticancer therapy, excluding alopecia and CTCAE Grade 2 peripheral neuropathy.
2.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.
3.Any significant cardiac diseases currently or within the last 6 months such as:
(a) unstable angina pectoris
(b) acute myocardial infarction, congestive heart failure
(c) conduction abnormality not controlled with pacemaker or medication
(d) significant ventricular or supraventricular arrhythmias
4.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.
5.Known to have tested positive for human immunodeficiency virus or active tuberculosis infection.
6.Known active hepatitis infection, positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening.
7.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.
8.Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
9.Use of an anti-cancer treatment drug ≤ 21 days (≤ 6 weeks for nitroureas or mitomycin C) or use of an investigational product within 5 half-lives prior to the first dose of adavosertib.
10.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.
11.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.
12.Currently pregnant (confirmed with positive pregnancy test) or breast feeding.

No locations available

Arms	Assigned Interventions
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.	-

Documents available

redactedCSRsynopsis required on EudraCT instead of ERF (study 1 terminated)
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]