Ovarian CancerPhase 1NCT03895788
A Study of Niraparib in Combination With Brivanib in Recurrent Ovarian Cancer
A Phase 1 study testing niraparib and Brivanib in people with Ovarian Cancer, run by Hunan Cancer Hospital at 1 site in China.
Trial summary
Open-label, cohort study to determine the safety and tolerability of the combination of daily niraparib and daily brivanib for one 28-day cycle in patients with advanced ovarian cancer. 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?
- niraparib and Brivanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 14 Jan 2019to Mar 2020
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent .
- Female, age ≥ 18 years.
- Histologically confirmed diagnosis of ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- Patients must have ovarian cancer and have failed at least 1 prior line of therapy
- Life expectancy of more than 16 weeks.
- ECOG 0-1.
Show all 20Show fewer
- Patient agrees to blood draws during study for the gBRCA test
- Has good organ function, including:
- Absolute neutrophil count ≥1,500/µL
- Platelets ≥125,000/µL
- Hemoglobin ≥10 g/dL
- Serum creatinine ≤1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥60 mL/min using the Cockcroft-Gault equation
- Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤1 x ULN
- Aspartate aminotransferase and alanine aminotransferase ≤2.5 x ULN unless liver metastases are present, in which case they must be ≤5 x ULN
- Female patient has a negative serum pregnancy test within 3 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 3 months after the last dose of study treatment, or is of non-childbearing potential. Non-childbearing potential is defined as follows (by other than medical reasons):
- ≥45 years and <60 years of age and has not had menses for >1 year
- ≥60 years of age
- Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation.
- Is able to adhere to the protocol.
- Has recovered from previous chemotherapy induced toxic side effects to ≤ grade 1 CTCAE or basal level, apart from ≤ grade 2 CTCAE peripheral neuropathy or hair loss symptoms at steady state.
Who cannot join
- Has a known hypersensitivity to the active or inactive ingredients of ZL-2306 (niraparib) or compound which has similar chemical structure to ZL-2306 (niraparib).
- Has a known hypersensitivity to the active or inactive ingredients of brivanib or compound which has similar chemical structure to brivanib.
- Has symptomatic uncontrolled brain or leptomeningeal metastasis.
- Major surgery or chemotherapy within 3 weeks of starting the study or patient has not recovered from any effects of the surgery.
- Receive palliative radiotherapy encompassing > 20% of the bone marrow within 1 week of entering the study.
- Be diagnosed any invasive cancer other than ovarian cancer (apart from cured basal cell carcinoma and squamous cell carcinoma) within 2 years prior to study enrolment.
Show all 12Show fewer
- Patient must has any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
- Has other serious or uncontrolled disease
- Has any disease, treatment and laboratory abnormality that may interfere the study results and affect the fully attendance of study. Or the patient is considered to be not suitable for the study by the investigator. Cannot receive platelet or red blood cell transfusion within 4 weeks of study drug administration.
- Pregnant, breastfeeding or expecting to conceive children during the study treatment period.
- Corrected QT (QTc) interval > 450 msec.
- Prior PARP inhibitor therapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jing Wang
Changsha, Hunan
Jing Wang, MD, +86-18908482599 ext. +8618908482599, wangjing189@163.com
About this study
Official title: An Open-Label, Single-Arm, Phase I Clinical Trial to Evaluate the Safety and Tolerability of ZL-2306 (Niraparib) in Combination With Brivanib in Patients With Recurrent Ovarian Cancer
Open-label, cohort study to determine the safety and tolerability of the combination of daily niraparib and daily brivanib for one 28-day cycle in patients with advanced ovarian cancer.
- Conditions
- Ovarian Cancer
- Being tested
- niraparib, Brivanib
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
niraparibDrug
Niraparib will be administered as a flat-fixed dose (100mg or 200 mg, daily) depending on the cohort the patient is enrolled to, and not by body weight or body surface area. Each dose should be swallowed whole without chewing. The consumption of water is permissible. Patients should take doses at approximately the same times each day, and record this information in the patient diary. Patients will be provided with a diary in which to record their intake of study drug. However, the actual number of doses taken by the patient must be calculated from the number of tablets dispensed and returned.
BrivanibDrug
Brivanib will be administered as a flat-fixed dose (200mg, 400 mg, or 600 mg daily) depending on the cohort the patient is enrolled to, and not by body weight or body surface area.
| Study group | Role | What they receive |
|---|---|---|
| niraparib and brivanib | Experimental | Subjects will be assigned into niraparib 100mg+brivanib 200mg, niraparib 200mg+brivanib 200mg, niraparib 200mg+brivanib 400mg, niraparib 200mg+brivanib 600mg dose group at the first day of the first cycle. Receives: Drug: niraparib; Drug: Brivanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
To determine the maximum tolerated dose of the combination of niraparib and brivanib for the treatment of patients with advanced ovarian cancer. The maximum tolerated dose (MTD) that is defined as the dose level at which less than one-third of patients will experience a dose-limiting toxicity (DLT).
Measured: 1 year
Secondary outcomes (1)
Assess the toxicity of the combination of niraparib and brivanib in each cohort by number of participants with treatment related adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start14 Jan 2019
- Primary completionDec 2019 (estimated)
- Study completionMar 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895788
- Sponsor's protocol ID
- CH1809001
- Status last verified
- Mar 2019
- First submitted
- 28 Feb 2019
- Last updated
- 29 Mar 2019
- Results posted
- 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 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Phase I Clinical Trial to Evaluate the Safety and Tolerability of ZL-2306 (Niraparib) in Combination With Brivanib in Patients With Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03895788
- Acronym / sponsor ID
- CH1809001
- Conditions
- Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 29 Mar 2019 (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.
Open-label, cohort study to determine the safety and tolerability of the combination of daily niraparib and daily brivanib for one 28-day cycle in patients with advanced ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| niraparib and brivanib | Experimental | Drug: niraparib, Drug: BrivanibSubjects will be assigned into niraparib 100mg+brivanib 200mg, niraparib 200mg+brivanib 200mg, niraparib 200mg+brivanib 400mg, niraparib 200mg+brivanib 600mg dose group at the first day of the first cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Signed informed consent .
- Female, age ≥ 18 years.
- Histologically confirmed diagnosis of ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- Patients must have ovarian cancer and have failed at least 1 prior line of therapy
- Life expectancy of more than 16 weeks.
Key exclusion criteria (12 listed)
- Has a known hypersensitivity to the active or inactive ingredients of ZL-2306 (niraparib) or compound which has similar chemical structure to ZL-2306 (niraparib).
- Has a known hypersensitivity to the active or inactive ingredients of brivanib or compound which has similar chemical structure to brivanib.
- Has symptomatic uncontrolled brain or leptomeningeal metastasis.
- Major surgery or chemotherapy within 3 weeks of starting the study or patient has not recovered from any effects of the surgery.
- Receive palliative radiotherapy encompassing > 20% of the bone marrow within 1 week of entering the study.
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 |
|---|---|---|
| niraparibNiraparib will be administered as a flat-fixed dose (100mg or 200 mg, daily) depending on the cohort the patient is enrolled to, and not by body weight or body surface area. Each dose should be swallowed whole without chewing. The consumption of water is permissible. Patients should take doses at approximately the same times each day, and record this information in the patient diary. Patients will be provided with a diary in which to record their intake of study drug. However, the actual number of doses taken by the patient must be calculated from the number of tablets dispensed and returned. | Drug | niraparib and brivanib |
| BrivanibBrivanib will be administered as a flat-fixed dose (200mg, 400 mg, or 600 mg daily) depending on the cohort the patient is enrolled to, and not by body weight or body surface area. | Drug | niraparib and brivanib |
Primary outcome
Maximum tolerated dose
Time frame: 1 year
To determine the maximum tolerated dose of the combination of niraparib and brivanib for the treatment of patients with advanced ovarian cancer. The maximum tolerated dose (MTD) that is defined as the dose level at which less than one-third of patients will experience a dose-limiting toxicity (DLT).
1 secondary outcome
Assess the toxicity of the combination of niraparib and brivanib in each cohort by number of participants with treatment related adverse events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
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 niraparib and Brivanib in people with Ovarian Cancer, run by Hunan Cancer Hospital at 1 site in China.
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 20 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 29 Mar 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Wang (+86-18908482599, wangjing189@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (time frame: 1 year). 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 2019.