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Ovarian CancerPhase 1NCT03763123

A Phase 1b Study of Sevacizumab in Combination With Chemotherapy in Chinese Patients With Platinum-Resistant Recurrent Ovarian Cancer.

A Phase 1 study testing Sevacizumab, Paclitaxel and Topotecan in people with Ovarian Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 6 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in combination with Chemotherapy in Chinese patients with Platinum-Resistant Recurrent 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?
Sevacizumab, Paclitaxel and Topotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
6 sitesChina
Study dates
24 Apr 2018to 31 Dec 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

  • age≥18 years
  • Histologically documented platinum resistant
  • EOC, FTC, or PPC of the following types: adenocarcinoma not otherwise specified (NOS), clear cell adenocarcinoma, endometriod adenocarcinoma, malignant Brenner's tumor, mixed epithelial carcinoma, mucinous adenocarcinoma, serous adenocarcinoma, transitional cell carcinoma and undifferentiated carcinoma.
  • At least one measurable leision. (according to RECIST 1.1 )
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1.
  • Adequate hematologic function: ANC ≥ 1.5 × 10^9 /L, HB ≥ 90 g /L (blood transfusion allowed), PLT ≥ 100 ×10^9 /L; Adequate hepatic function: ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN, TBIL ≤ 1.5 × ULN (patients with liver metastases ALT ≤ 5 × ULN, AST ≤ 5 × ULN); Adequate renal function: creatinine ≤ 1 × ULN; Coagulation function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN
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  • Progression within 6 months from completion of a minimum of 4 platinum therapy cycles.
  • Life expectancy ≥12 weeks.
  • At least 4 weeks from the last chemotherapy. If patients received anti-tumor biological products, at least four t1/2 of washout period is needed
  • Toxicity from previous treatment has to restore to ≤ grade 1 (NCI CTC4.0)
  • Patients signed written inform consent.
  • Willingness and capability to communicate with investigators and to comply with protocol requirements

Who cannot join

  • Previous treatment with > 2 anti-cancer regimens.
  • Patients whose disease was refractory to their previous platinum treatment. (Refractory disease was defined as those patients who progressed during the preceding platinum treatment.)
  • Ovarian tumors with low malignant potential (i.e. borderline tumors).
  • Patients with a prior invasive malignancy (except non-melanoma skin cancer) or whose prior malignancy treatment contraindicated the current protocol therapy.
  • Any prior radiotherapy to the pelvis or abdomen.
  • Patients with serious non-healing wound, ulcer, or bone fracture.
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  • patients with a history of bowel obstruction (including subocclusive disease) related to underlying disease, a history of abdominal fistula, GI perforation, or intra-abdominal abscess or evidence of rectosigmoid involvement by pelvic examination, bowel involvement on computed tomography, or clinical symptoms of bowel obstruction.
  • Serious infection requiring intravenous antibiotic therapy
  • history or evidence of thrombotic or hemorrhagic disorder within 6 months before first study treatment
  • untreated CNS disease unrelated to cancer or symptomatic CNS metastasis
  • Patients with clinically significant cardiovascular disease. This included:Uncontrolled hypertension, defined as systolic > 150 mmHg or diastolic > 90 mmHg;Myocardial infarction or unstable angina > 6 months prior to registration;New York Heart Association (NYHA) Grade II or greater congestive heart failure;Serious cardiac arrhythmia requiring medication. This did not include asymptomatic, atrial fibrillation with controlled ventricular rate.
  • left ventricular ejection fraction below the institutional lower limit of normal
  • pre-existing neuropathy ≥ CTC Grade 2 for those in the paclitaxel group
  • Known allergies to any excipient in the study drug
  • Pregnant and lactating women
  • Patients with proteinuria (urine protein >1+ at screening, or urine protein 1+, not recover to normal value within 24h)
  • Previously received anti-VEGF protein drugs, such as Bevacizumab, Sevacizumab
  • Patients with or with anticipation of invasive procedures as defined below:Major surgical procedure or significant traumatic injury within 28 days prior to the first date of sevacizumab therapy;Major surgical procedure anticipated during the course of the study. This included, but was not limited to abdominal surgery (laparotomy or laparoscopy) prior to disease progression;Core biopsy, within 7 days prior to randomization.
  • Participation in other clinical trials within 4 weeks before enrollment
  • The investigators consider the patients are not suitable for this trial.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites, 5 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

    zheng hong, 010-88196102, zhhong306@hotmail.com

    zheng hong

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

    Wu Lingying, 010-87788787, wulingying@csco.org.cn

    wu lingying

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Zhang Keqiang, 0731-89762695 ext. 073189762695, 1465217100@qq.com

    Zhang Keqiang, 073189762695 ext. 073189762695, 1465217100@qq.com

    Recruiting

  • The first affiliated hospital,sun yat-sen university

    Guangzhou, Guangdong

    Yao Shuzhong, 020-87755766 ext. 8185, yszlfy@163.com

    Yao Shuzhong, 02087755766 ext. 02087755766, yszlfy@163.com

    Recruiting

  • the Affiliated Cancer Hospital of Harbin Medical University

    Harbin, Hei Longjiang

    Suspended

  • Wuhan Union Hospital

    Wuhan, Hunan

    Li Guiling, 027-83691785, lgl6714@163.com

    Li Guiling

    Recruiting

Other trials in China

About this study

Official title: A Phase Ib, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody(Sevacizumab) Injection Plus Chemotherapy in Chinese Patients With Platinum-Resistant Recurrent Ovarian Cancer.

This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in combination with Chemotherapy in Chinese patients with Platinum-Resistant Recurrent Ovarian Cancer. This study includes two stages. Stage 1 is the dose-escalation stage. Once the maximum tolerated dose (MTD of Sevacizumab has been established, additional patients will be enrolled in the cohort-expansion stage (Stage 2).

Read the detailed description

This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in combination with Chemotherapy in Chinese patients with Platinum-Resistant Recurrent Ovarian Cancer. This study includes two stages. Stage 1 is the dose-escalation stage. Once the maximum tolerated dose (MTD of Sevacizumab has been established, additional patients will be enrolled in the cohort-expansion stage (Stage 2).

Conditions
Ovarian Cancer
Being tested
Sevacizumab, Paclitaxel, Topotecan
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SevacizumabDrug

    Drug: Sevacizumab escalating doses of Sevacizumab : 0.5mg/kg，1mg/kg，1.5mg/kg and 2mg/kg

  • PaclitaxelDrug

    paclitaxel 80mg/m2 as a > 3-hour IV infusion on days 1, 8,15, and 22 every 4 weeks;

  • TopotecanDrug

    topotecan 4 mg/m2 as a >30 minute IV infusion on days 1, 8, and 15 every 4 weeks ;

Study groups in NCT03763123
Study groupRoleWhat they receive
Sevacizumab +Chemotherapy Combined chemotherapy drug includingExperimentalInvestigators selected single-agent chemotherapy on an individual patient basis from the following options, with appropriate premedication according to local standards: paclitaxel 80mg/m2 intravenously (IV)on days 1, 8, 15, and 22 every 4 weeks; or topotecan 4 mg/m2 IV on days 1, 8, and 15 every 4 weeks.
Receives: Drug: Sevacizumab; Drug: Paclitaxel; Drug: Topotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD)

    Measured: 3 years

  2. The ratio of adverse of event

    Measured: 3 years

Secondary outcomes (7)

  1. Maximum Plasma Concentration [Cmax]

    Maximum Plasma Concentration [Cmax]

    Measured: 3 years

  2. Area Under the Curve [AUC],

    Area Under the Curve [AUC]

    Measured: 3 years

  3. Tmax

    Tmax for Cmax of sevacizumab

    Measured: 3 years

  4. Objective Response Rate (ORR)

    Measured: 3 years

  5. Disease Control Rate (DCR)

    Measured: 3 years

  6. Overall Survival (OS)

    Measured: 3 years

  7. Progression Free Survival (PFS)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2018
  2. Study start24 Apr 2018
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

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
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03763123
Sponsor's protocol ID
SIM-63-OC-101
Status last verified
Dec 2018
First submitted
25 Nov 2018
Last updated
4 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sevacizumab, Paclitaxel and Topotecan in people with Ovarian Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 6 sites 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 12 inclusion and 20 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 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03763123.

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 4 Dec 2018.

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