ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001118392

Ethics application status

Approved

Date submitted

11/07/2017

Date registered

31/07/2017

Date last updated

8/05/2019

Date data sharing statement initially provided

8/05/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Treatment of ectopic pregnancies of participants with vinorelbine tablets.

Scientific title

Safety and efficacy of oral vinorelbine in treatment of ectopic pregnancies

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

VINO trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

ECTOPIC PREGNANCY

Condition category

Condition code

Reproductive Health and Childbirth

Other reproductive health and childbirth disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Given the promising in vitro and in vivo data, coupled with vinorelbine’s established safety and tolerability profiles in the treatment of human oncology patients, we now wish to progress this concept to the clinic. We hope to recruit 20 participants with stable ectopic pregnancies and treat them each with 2 doses of 60mg/m² of oral vinoralbine, spaced one week apart, instead of methotrexate. The primary aims of this study are to assess the safety, toxicity and tolerability profiles of vinorelbine when administered exclusively to a cohort of women with stable ectopic pregnancies.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

No control group in this study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The primary objective of this study is to assess the safety, toxicity and tolerability of administering vinorelbine to patients with ectopic pregnancies with blood tests.

Timepoint [1]

The end (resolution) of the ectopic pregnancy – either when serum hCG levels return to less than 5; or when the pregnancy is surgically excised. Participants will have FBC, U&Es, LFTs and hCG done on day 0, day 4 and day 7 to test for neutropaenia and any derangement in liver enzymes.

Secondary outcome [1]

Length of time from treatment initiation to resolution of ectopic pregnancy by review of medical records.

Timepoint [1]

The end (resolution) of the ectopic pregnancy – either when serum hCG levels return to less than 5; or when the pregnancy is surgically excised,t

Secondary outcome [2]

Failure of medical management . Clinical signs and symptoms of a ruptured ectopic.

Timepoint [2]

Within 30 days post documented resolution of ectopic pregnancy

Eligibility

Key inclusion criteria

• Aged 18-50 years old
• English speaking
• Able to provide informed consent to participate
• A diagnosis of a tubal ectopic pregnancy on transvaginal ultrasound
• A stable ectopic pregnancy (no evidence of bleeding or rupture)
• A pre-treatment serum Human Chorionic Gonadotrophin (hCG) level of 1,000 – 3,000 IU/L
• Adnexal mass less than or equal to 3.0 cm, with no fetal cardiac activity

Minimum age

18 Years

Maximum age

50 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

• Unable to provide informed consent to participate
• A multiple pregnancy
• Contraindication(s) to vinorelbine or to medical management of ectopic pregnancy
• Immunodeficiency disorder(s)
• A current malignancy
• Received chemotherapy or radiation therapy in the previous five years
• Concomitant disease which could significantly impair gastric absorption (Inflammatory bowel disease, coeliac, etc.)
• History of surgical resection of the stomach/small bowel
• Breastfeeding
• Hepatic impairment, renal impairment, or haematological toxicity

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Phase 2

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Statistical analysis for this study will be performed using GraphPad Prism 6 (GraphPad Software, La Jolla, CA). Given the study design and objectives of this particular trial:
• There is no comparison arm, so clinical variables and the clinical course will be presented as descriptive statistics
• There is no power calculation to perform
• Continuous variables will be statistically analysed using a t-test (parametric) or a Mann-Whitney test (non-parametric), as appropriate
• Categorical variables will be statistically analysed using a chi-squared test or Fisher’s exact test, as appropriate
• Biochemical pathology results will be assessed as continuous variables
• A p value of <0.05 will be considered statistically significant.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/02/2018

Actual

9/08/2018

Date of last participant enrolment

Anticipated

4/02/2020

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Prathima Chowdary

Address [1]

North Shore Hospital,
124 Shakespeare Road,
Takapuna,
Auckland 0620, NZ

Country [1]

New Zealand

Primary sponsor type

Hospital

Name

North Shore Hospital

Address

North Shore Hospital,
124 Shakespeare Road,
Takapuna,
Auckland 0620, NZ

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committee

Ethics committee address [1]


Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

03/08/2017

Approval date [1]

02/02/2018

Ethics approval number [1]

Summary

Brief summary

Ectopic pregnancies are pregnancies that occur outside of the womb, with the vast majority located in the Fallopian tube (the tube which carries a fertilised egg to the womb). They are potentially life threatening as they can erode maternal blood vessels and cause fatal internal bleeding. They are relatively common, representing around 2% of pregnancies. 

If an ectopic pregnancy is identified early and is small in size, a drug called methotrexate can be administered via injection. However, only a small number of ectopic pregnancies (~25%) are identified early enough to be suitable for this medication. Additionally, methotrexate is unsuccessful in treating ectopic pregnancies in up to 30% of cases. This means that the majority of ectopic pregnancies are ultimately removed surgically. This exposes many affected women to both surgical and anaesthetic risks; is complex (requiring doctors with specialist surgical skills); and can involve the removal of the woman’s Fallopian tube. As fertility preservation is an important concern in this area of medicine, the development of a new medical therapy with a higher success rate than methotrexate would be a major advance in the clinical care of women who have ectopic pregnancies.

Excitingly, we have discovered in pre-clinical laboratory studies that vinorelbine, an orally available chemotherapeutic medication, may be appropriate for use as an alternative to methotrexate in the medical treatment of ectopic pregnancies. Specifically, we have found in our laboratory studies that vinorelbine is 1,000 to 10,000 times more effective than methotrexate at killing placental cells, is more effective than methotrexate in an animal model ectopic pregnancy, does not cause cell death of donated human Fallopian tubes and does not impact upon subsequent breeding in mice (after a four week washout period). Together, these findings indicate that vinorelbine may not impede future fertility, and that may be an efficacious treatment for ectopic pregnancy. 

Given these promising pre-clinical results, we hope to progress this concept and eventually translate these laboratory findings into clinical care. We propose to begin this process with a proof-of-concept, early phase clinical trial. We will recruit 20 women with stable ectopic pregnancies and treat the participants with two doses of 60mg/m² of oral vinorelbine, spaced one week apart. We will assess the safety, toxicity and tolerability of vinorelbine therapy in these women, as well as monitoring the effectiveness of vinorelbine in killing placental cells and resolving ectopic pregnancies. If successful, we will gain sufficient evidence to progress our investigations of vinorelbine as a treatment for ectopic pregnancies to a large-scale, randomized clinical trial. We hope that it may form the basis for an efficient and safe future medical treatment option for this group of women who do not wish to undergo surgery or have their tube removed.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Prathima Chowdary

Address

Waitemata District Health Board
North Shore Hospital
Auckland 0620, NZ

Country

New Zealand

Phone

+6494868900

Fax

prath1mak@yahoo.co.in

Contact person for public queries

Name

Prathima Chowdary

Address

Waitemata District Health Board
North Shore Hospital
Auckland 0620, NZ

Country

New Zealand

Phone

+6494868900

Fax

prath1mak@yahoo.co.in

Contact person for scientific queries

Name

Prathima Chowdary

Address

Waitemata District Health Board
North Shore Hospital
Auckland 0620, NZ

Country

New Zealand

Phone

+6494868900

Fax

prath1mak@yahoo.co.in

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1983	Informed consent form					373273-(Uploaded-02-05-2019-18-54-36)-Study-related document.doc
1984	Ethical approval					373273-(Uploaded-02-05-2019-18-55-54)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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