Ovarian CancerPhase 2NCT02836028
A Study Evaluating Talazoparib in Relapsed Ovarian, Fallopian Tube, and Peritoneal Cancer
A Phase 2 study testing Talazoparib and Temozolomide in people with Ovarian Cancer, run by Pfizer.
Trial summary
The purpose of this phase 2, multiple-cohort, randomized, open-label, international study of talazoparib (a poly (ADP-ribose) polymerase (PARP) inhibitor) is to compare the efficacy and safety of talazoparib monotherapy and talazoparib plus temozolomide in women with relapsed ovarian, fallopian tube, and peritoneal… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Talazoparib and Temozolomide
- 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
- Oct 2016to Jun 2020
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ≥ 18 years of age and willing and able to provide informed consent
- Relapsed, histologically confirmed ovarian, fallopian tube, and peritoneal cancer. Histologic subtypes include serous, endometrioid, clear-cell, mixed, undifferentiated histology, and carcinosarcoma.
- Sufficient archival tumor tissue available or consent to a fresh tissue biopsy for biomarker analysis. Consent to blood sample collection for biomarker analysis is required.
- Disease progression per RECIST 1.1 during or after the last treatment. Have metastatic disease with at least 1 target tumor lesion measurable per RECIST 1.1 on the screening scan. Lesions used for biopsies cannot be designated as a measurable lesion for RECIST 1.1 assessments.
- Additional criteria for cohort 1 include the following:
- Have a deleterious germline or a somatic BRCA1 or BRCA2 mutation, or a high diagnostic HRD test score (myChoice score ≥ 42), which represents a loss of DNA repair function based on testing performed at a sponsor-approved laboratory
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- 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 (COHORT 1 ONLY)
- Additional criteria for cohorts 2 and 3 include the following:
- Received at least 2 platinum-based chemotherapy regimens (including first-line chemotherapy; prior bevacizumab is allowed) and the last dose is ≥ 28 days before randomization
- Received prior PARP inhibitor treatment as a single agent or in combination therapy regimen and the last dose is ≥ 28 days before randomization, as follows:
- For cohort 2 only: Received PARP inhibitor treatment for ≥ 6 months and had a response of CR, PR, or stable disease for ≥ 6 months
- For cohort 3 only: Received PARP inhibitor treatment for < 6 months with no response (disease progression or stable disease)
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Estimated life expectancy of ≥ 3 months.
- Able to swallow drugs, have no known intolerance to study drugs or excipients, and able to comply with study requirements.
Who cannot join
- Have not recovered (recovery is defined as National Cancer Institute Common 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).
- Diagnosis of MDS.
About this study
Official title: A Phase 2, Multiple-Cohort, Open-Label, International Study of Talazoparib Monotherapy and Talazoparib Plus Temozolomide in Women With Relapsed Ovarian, Fallopian Tube, and Peritoneal Cancer
The purpose of this phase 2, multiple-cohort, randomized, open-label, international study of talazoparib (a poly (ADP-ribose) polymerase (PARP) inhibitor) is to compare the efficacy and safety of talazoparib monotherapy and talazoparib plus temozolomide in women with relapsed ovarian, fallopian tube, and peritoneal cancer.
- Conditions
- Ovarian Cancer
- Being tested
- Talazoparib, Temozolomide
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalazoparibDrug
Also called MDV3800, BMN673
Talazoparib monotherapy 1mg/day orally
TemozolomideDrug
temozolomide 37.5 mg/m2 on days 1-5 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| talazoparib | Experimental | Cohorts 1A (PARP inhibitor naïve), 2A (PARP inhibitor sensitive), and 3A (PARP inhibitor refractory) Receives: Drug: Talazoparib |
| talazoparib + temozolomide | Active comparator | Cohorts 1B (PARP inhibitor naïve), 2B (PARP inhibitor sensitive), and 3B (PARP inhibitor refractory) Receives: Drug: Talazoparib; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Objective Response Rate (ORR)
Measured: Anticipated in about 44 months following first patient enrolled
Secondary outcomes (9)
Progression-free survival (PFS)
Measured: Anticipated in about 44 months following first patient enrolled
PFS at 24 weeks
Measured: Anticipated in about 44 months following first patient enrolled
Gynecologic Cancer Intergroup (GCIG) CA125 response rate
Measured: Anticipated in about 44 months following first patient enrolled
Clinical benefit rate at 24 weeks
Measured: Anticipated in about 44 months following first patient enrolled
Duration of response (DOR)
Measured: Anticipated in about 44 months following first patient enrolled
Time to response
Measured: Anticipated in about 44 months following first patient enrolled
Overall survival
Measured: Anticipated in about 44 months following first patient enrolled
Safety as assessed by percentage of patients with any Adverse Event (AE), AE leading to Study Drug Discontinuation, AE leading to death, SAE, AE related to study drug, SAE related to study drug.
Measured: Anticipated in about 44 months following first patient enrolled
Pharmacokinetics of talazoparib as assessed by trough plasma concentrations
Measured: Anticipated in about 44 months following first patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Myriad Genetic Laboratories, Inc., Medivation, Inc.
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836028
- Sponsor's protocol ID
- MDV3800-11
- Status last verified
- Sep 2018
- First submitted
- 14 Jul 2016
- Last updated
- 18 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multiple-Cohort, Open-Label, International Study of Talazoparib Monotherapy and Talazoparib Plus Temozolomide in Women With Relapsed Ovarian, Fallopian Tube, and Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT02836028
- Acronym / sponsor ID
- MDV3800-11
- Conditions
- Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Myriad Genetic Laboratories, Inc., Medivation, Inc.
- Study start
- Oct 2016
- Primary completion
- Jun 2020 (estimated)
- First posted
- 18 Jul 2016 (estimated)
- 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.
The purpose of this phase 2, multiple-cohort, randomized, open-label, international study of talazoparib (a poly (ADP-ribose) polymerase (PARP) inhibitor) is to compare the efficacy and safety of talazoparib monotherapy and talazoparib plus temozolomide in women with relapsed ovarian, fallopian tube, and peritoneal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| talazoparib | Experimental | Drug: TalazoparibCohorts 1A (PARP inhibitor naïve), 2A (PARP inhibitor sensitive), and 3A (PARP inhibitor refractory) |
| talazoparib + temozolomide | Active comparator | Drug: Talazoparib, Drug: TemozolomideCohorts 1B (PARP inhibitor naïve), 2B (PARP inhibitor sensitive), and 3B (PARP inhibitor refractory) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Women ≥ 18 years of age and willing and able to provide informed consent
- Relapsed, histologically confirmed ovarian, fallopian tube, and peritoneal cancer. Histologic subtypes include serous, endometrioid, clear-cell, mixed, undifferentiated histology, and carcinosarcoma.
- Sufficient archival tumor tissue available or consent to a fresh tissue biopsy for biomarker analysis. Consent to blood sample collection for biomarker analysis is required.
- Disease progression per RECIST 1.1 during or after the last treatment. Have metastatic disease with at least 1 target tumor lesion measurable per RECIST 1.1 on the screening scan. Lesions used for biopsies cannot be designated as a measurable lesion for RECIST 1.1 assessments.
- Additional criteria for cohort 1 include the following:
Key exclusion criteria (6 listed)
- Have not recovered (recovery is defined as National Cancer Institute Common 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 |
|---|---|---|
| TalazoparibAlso: MDV3800, BMN673Talazoparib monotherapy 1mg/day orally | Drug | talazoparib, talazoparib + temozolomide |
| Temozolomidetemozolomide 37.5 mg/m2 on days 1-5 of each cycle | Drug | talazoparib + temozolomide |
Primary outcome
Determine Objective Response Rate (ORR)
Time frame: Anticipated in about 44 months following first patient enrolled
9 secondary outcomes
Progression-free survival (PFS)
Time frame: Anticipated in about 44 months following first patient enrolled
PFS at 24 weeks
Time frame: Anticipated in about 44 months following first patient enrolled
Gynecologic Cancer Intergroup (GCIG) CA125 response rate
Time frame: Anticipated in about 44 months following first patient enrolled
Clinical benefit rate at 24 weeks
Time frame: Anticipated in about 44 months following first patient enrolled
Duration of response (DOR)
Time frame: Anticipated in about 44 months following first patient enrolled
Time to response
Time frame: Anticipated in about 44 months following first patient enrolled
Overall survival
Time frame: Anticipated in about 44 months following first patient enrolled
Safety as assessed by percentage of patients with any Adverse Event (AE), AE leading to Study Drug Discontinuation, AE leading to death, SAE, AE related to study drug, SAE related to study drug.
Time frame: Anticipated in about 44 months following first patient enrolled
Pharmacokinetics of talazoparib as assessed by trough plasma concentrations
Time frame: Anticipated in about 44 months following first patient enrolled
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 18 Sep 2018.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Talazoparib and Temozolomide in people with Ovarian Cancer, run by Pfizer.
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 16 inclusion and 6 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 18 Sep 2018. 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?
Determine Objective Response Rate (ORR) (time frame: Anticipated in about 44 months 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 18 Sep 2018.