Advanced or Recurrent Solid TumorsPhase 1NCT03426254
Comparison of Safety and Clinical Benefit of Injections Subcutaneously Talazoparib Versus Oral Talazoparib in Patients With Solid Tumors
A Phase 1 study testing Injections Subcutaneously Talazoparib and Oral capsules Talazoparib in people with Advanced or Recurrent Solid Tumors and Breast Neoplasm, run by Center Trials & Treatment at 1 site in Albania.
Trial summary
To assess the safety and efficacy of two forms of Talazoparib therapy (injections subcutaneously Talazoparib and oral form for the treatment in the equivalent therapeutics dose Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Advanced or Recurrent Solid Tumors, Breast Neoplasm
- What is being tested?
- Injections Subcutaneously Talazoparib and Oral capsules Talazoparib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAlbania
- Study dates
- 10 Nov 2022to 10 Jan 2024
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent form (by the patient or a legally acceptable representative as per the local regulations) obtained prior to initiation of any study-specific procedure and treatment.
- Female of at least 21 years of age.
- Histologically or cytologically confirmed advanced solid tumor with no available standard approved treatment options in the opinion of the Investigator
- Eastern Cooperative Oncology Group (ECOG) Performance status (PS) ≤ 2.
- Renal function at screening and enrollment as defined by the
- Patient has had no clinically significant change in renal status within 3 months prior to screening, according to Investigator's review of clinical patient records.
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- Patient is not currently on hemodialysis and/or peritoneal dialysis for management of chronic kidney disease or acute failure/conditions.
- Patient has no unstable renal function, defined as a change in estimated glomerular filtration rate (eGFR) (calculated with the MDRD equation) of > 25% for patients with mild and moderate renal impaired or as a change in eGFR > 30% for patients with severe renal impaired, from screening to enrollment.
- Received at least 1 and no more than 3 platinum-based chemotherapy regimens (prior bevacizumab is allowed) and the last dose is ≥ 28 days before randomization
- No prior PARP inhibitor treatment
- Adequate other organ function at screening and enrollment.
- Female patients of childbearing potential must have a negative serum pregnancy test at screening, and must agree to use a highly effective birth control method from the time of the first dose of study drug through 60 days after the last dose of study drug.
- Female patients must not be breastfeeding at screening nor during the study participation until 60 days after the last dose of study drug.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Who cannot join
- Terminology Criteria for Adverse Events [CTCAE] grade ≤ 1) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
- Use of any investigational agent within 14 days before randomization.
- Had > 2 paracentesis procedures within 28 days before randomization.
- Major surgery within 14 days before randomization.
- Requirement for intravenous alimentation (at the time of randomization).
- Seropositive for human immunodeficiency virus (HIV).
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- Any serious or unstable medical condition that interferes with ability to tolerate treatment or assessments associated with the protocol.
- Gastrointestinal disorder affecting absorption.
- Known or suspected hypersensitivity to any of the talazoparib capsule components.
- Any condition or reason that interferes with ability to participate in the study, tolerate treatment or assessments associated with the protocol, causes undue risk, or complicates the interpretation of safety data, in the opinion of the Investigator or Medical Monitor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Safety and Clinical Benefit of Injections Subcutaneously Talazoparib Versus Oral Talazoparib in Patients With Advanced Solid Tumors ( Phase I )
To assess the safety and efficacy of two forms of Talazoparib therapy (injections subcutaneously Talazoparib and oral form for the treatment in the equivalent therapeutics dose
Read the detailed description
The intent of this study was to assess the safety and efficacy of two forms of Talazoparib therapy for the treatment of advanced solid tumors . After an enrollment period, patients will randomized to receive oral Talazoparib (1 mg, one times a day ) or subcutaneously Talazoparib (1 mg by subcutaneous injection with NovoPen / Autopen) one times a day in the appropriate volume
- Being tested
- Injections Subcutaneously Talazoparib, Oral capsules Talazoparib
- Keywords
- Subcutaneously Talazoparib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injections Subcutaneously TalazoparibBiological
Also called MDV3800, BMN673
Patients receive per day single dose of subcutaneous Injection contains 1 mg Talazoparib on days 1-28
Oral capsules TalazoparibDrug
Also called MDV3800, BMN673
Patients receive 1 mg of Talazoparib PO QD on days 1-28.
| Study group | Role | What they receive |
|---|---|---|
| Injections Subcutaneously Talazoparib | Experimental | Patients receive per day single dose of subcutaneous Injection contains 1 mg Talazoparib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Auto-Injector delivers a single dose of 1 mg Talazoparib injection (subcutaneous) Receives: Biological: Injections Subcutaneously Talazoparib |
| Oral capsules Talazoparib | Active comparator | Patients receive 1 mg of Talazoparib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Oral capsules Talazoparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of occurrence and evaluation of adverse events in the use of Subcutaneously Talazoparib ( 1 mg / dose )
Frequency of occurrence and evaluation of adverse events in the use of Subcutaneously Talazoparib , assessed by percentage of patients with any Adverse Event (AE), leading to Study Drug Discontinuation, Serious Adverse Event (SAE), related to study drug, SAE related to study drug.
Incidence of toxicity, graded according to the National Cancer Institute (NCI) CTCAE version 4.03 Incidence of toxicity, graded according to the National Cancer Institute (NCI) CTCAE version 4.03
Measured: Anticipated in about 12 month following first patient enrolled
Secondary outcomes (1)
Clinical Benefit of Injections Subcutaneously Talazoparib
Clinical benefit (CB) defined as any of the following, complete response, partial response, or stable disease for > 24 weeks by RECIST 1.1. Assessments performed using computed tomography (CT) or magnetic resonance imaging (MRI) or ultrasound examination (Use) scan every 9 weeks.
Measured: Every 9 weeks for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start10 Nov 2022 (estimated)
- Primary completion10 Dec 2023 (estimated)
- Study completion10 Jan 2024 (estimated)
Why it stopped: the company is liquidated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Recurrent Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intent of this study was to assess the safety and efficacy of two forms of Talazoparib therapy for the treatment of advanced solid tumors . After an enrollment period, patients will randomized to receive oral Talazoparib (1 mg, one times a day ) or subcutaneously Talazoparib (1 mg subcutaneous injection by pen-syringe / mechanical dispenser) .
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Trials & Treatment
- Sponsor type
- University, hospital or other
- Collaborators
- BioGene Pharmaceutical Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426254
- Sponsor's protocol ID
- TST-9-H
- Status last verified
- Mar 2023
- First submitted
- 27 Jan 2018
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety and Clinical Benefit of Injections Subcutaneously Talazoparib Versus Oral Talazoparib in Patients With Advanced Solid Tumors ( Phase I )
- ClinicalTrials.gov ID
- NCT03426254
- Acronym / sponsor ID
- TST-9-H
- Keywords
- Subcutaneously Talazoparib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the company is liquidated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Center Trials & TreatmentUniversity, hospital or other
- Collaborators
- BioGene Pharmaceutical Ltd.
- Study start
- 10 Nov 2022 (estimated)
- Primary completion
- 10 Dec 2023 (estimated)
- Study completion
- 10 Jan 2024 (estimated)
- First posted
- 8 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety and efficacy of two forms of Talazoparib therapy (injections subcutaneously Talazoparib and oral form for the treatment in the equivalent therapeutics dose
Detailed description
The intent of this study was to assess the safety and efficacy of two forms of Talazoparib therapy for the treatment of advanced solid tumors . After an enrollment period, patients will randomized to receive oral Talazoparib (1 mg, one times a day ) or subcutaneously Talazoparib (1 mg by subcutaneous injection with NovoPen / Autopen) one times a day in the appropriate volume
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intent of this study was to assess the safety and efficacy of two forms of Talazoparib therapy for the treatment of advanced solid tumors . After an enrollment period, patients will randomized to receive oral Talazoparib (1 mg, one times a day ) or subcutaneously Talazoparib (1 mg subcutaneous injection by pen-syringe / mechanical dispenser) .
| Arm | Type | Receives |
|---|---|---|
| Injections Subcutaneously Talazoparib | Experimental | Biological: Injections Subcutaneously TalazoparibPatients receive per day single dose of subcutaneous Injection contains 1 mg Talazoparib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Auto-Injector delivers a single dose of 1 mg Talazoparib injection (subcutaneous) |
| Oral capsules Talazoparib | Active comparator | Drug: Oral capsules TalazoparibPatients receive 1 mg of Talazoparib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed and dated informed consent form (by the patient or a legally acceptable representative as per the local regulations) obtained prior to initiation of any study-specific procedure and treatment.
- Female of at least 21 years of age.
- Histologically or cytologically confirmed advanced solid tumor with no available standard approved treatment options in the opinion of the Investigator
- Eastern Cooperative Oncology Group (ECOG) Performance status (PS) ≤ 2.
- Renal function at screening and enrollment as defined by the
Key exclusion criteria (10 listed)
- Terminology Criteria for Adverse Events [CTCAE] grade ≤ 1) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
- Use of any investigational agent within 14 days before randomization.
- Had > 2 paracentesis procedures within 28 days before randomization.
- Major surgery within 14 days before randomization.
- Requirement for intravenous alimentation (at the time of randomization).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injections Subcutaneously TalazoparibAlso: MDV3800, BMN673Patients receive per day single dose of subcutaneous Injection contains 1 mg Talazoparib on days 1-28 | Biological | Injections Subcutaneously Talazoparib |
| Oral capsules TalazoparibAlso: MDV3800, BMN673Patients receive 1 mg of Talazoparib PO QD on days 1-28. | Drug | Oral capsules Talazoparib |
Primary outcome
Frequency of occurrence and evaluation of adverse events in the use of Subcutaneously Talazoparib ( 1 mg / dose )
Time frame: Anticipated in about 12 month following first patient enrolled
Frequency of occurrence and evaluation of adverse events in the use of Subcutaneously Talazoparib , assessed by percentage of patients with any Adverse Event (AE), leading to Study Drug Discontinuation, Serious Adverse Event (SAE), related to study drug, SAE related to study drug. Incidence of toxicity, graded according to the National Cancer Institute (NCI) CTCAE version 4.03 Incidence of toxicity, graded according to the National Cancer Institute (NCI) CTCAE version 4.03
1 secondary outcome
Clinical Benefit of Injections Subcutaneously Talazoparib
Time frame: Every 9 weeks for 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Injections Subcutaneously Talazoparib and Oral capsules Talazoparib in people with Advanced or Recurrent Solid Tumors and Breast Neoplasm, run by Center Trials & Treatment at 1 site in Albania.
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 14 inclusion and 10 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 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Albania. 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 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?
Frequency of occurrence and evaluation of adverse events in the use of Subcutaneously Talazoparib ( 1 mg / dose ) (time frame: Anticipated in about 12 month following first patient enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2023.