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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03763123
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE November 25, 2018
First Posted Date  ICMJE December 4, 2018
Last Update Posted Date December 4, 2018
Actual Study Start Date  ICMJE April 24, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2018)
  • Maximum Tolerated Dose (MTD) [ Time Frame: 3 years ]
  • The ratio of adverse of event [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2018)
  • Maximum Plasma Concentration [Cmax] [ Time Frame: 3 years ]
    Maximum Plasma Concentration [Cmax]
  • Area Under the Curve [AUC], [ Time Frame: 3 years ]
    Area Under the Curve [AUC]
  • Tmax [ Time Frame: 3 years ]
    Tmax for Cmax of sevacizumab
  • Objective Response Rate (ORR) [ Time Frame: 3 years ]
  • Disease Control Rate (DCR) [ Time Frame: 3 years ]
  • Overall Survival (OS) [ Time Frame: 3 years ]
  • Progression Free Survival (PFS) [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1b Study of Sevacizumab in Combination With Chemotherapy in Chinese Patients With Platinum-Resistant Recurrent Ovarian Cancer.
Official Title  ICMJE 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.
Brief 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. 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).
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Drug: Sevacizumab
    Drug: Sevacizumab escalating doses of Sevacizumab : 0.5mg/kg,1mg/kg,1.5mg/kg and 2mg/kg
  • Drug: Paclitaxel
    paclitaxel 80mg/m2 as a > 3-hour IV infusion on days 1, 8,15, and 22 every 4 weeks;
  • Drug: Topotecan
    topotecan 4 mg/m2 as a >30 minute IV infusion on days 1, 8, and 15 every 4 weeks ;
Study Arms  ICMJE Experimental: Sevacizumab +Chemotherapy Combined chemotherapy drug including
Investigators 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.
Interventions:
  • Drug: Sevacizumab
  • Drug: Paclitaxel
  • Drug: Topotecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 1, 2018)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. age≥18 years
  2. Histologically documented platinum resistant
  3. 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.
  4. At least one measurable leision. (according to RECIST 1.1 )
  5. Eastern Cooperative Oncology Group performance status (ECOG PS) 0−1.
  6. 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
  7. Progression within 6 months from completion of a minimum of 4 platinum therapy cycles.
  8. Life expectancy ≥12 weeks.
  9. 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
  10. Toxicity from previous treatment has to restore to ≤ grade 1 (NCI CTC4.0)
  11. Patients signed written inform consent.
  12. Willingness and capability to communicate with investigators and to comply with protocol requirements

Exclusion Criteria:

  1. Previous treatment with > 2 anti-cancer regimens.
  2. Patients whose disease was refractory to their previous platinum treatment. (Refractory disease was defined as those patients who progressed during the preceding platinum treatment.)
  3. Ovarian tumors with low malignant potential (i.e. borderline tumors).
  4. Patients with a prior invasive malignancy (except non-melanoma skin cancer) or whose prior malignancy treatment contraindicated the current protocol therapy.
  5. Any prior radiotherapy to the pelvis or abdomen.
  6. Patients with serious non-healing wound, ulcer, or bone fracture.
  7. 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.
  8. Serious infection requiring intravenous antibiotic therapy
  9. history or evidence of thrombotic or hemorrhagic disorder within 6 months before first study treatment
  10. untreated CNS disease unrelated to cancer or symptomatic CNS metastasis
  11. 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.
  12. left ventricular ejection fraction below the institutional lower limit of normal
  13. pre-existing neuropathy ≥ CTC Grade 2 for those in the paclitaxel group
  14. Known allergies to any excipient in the study drug
  15. Pregnant and lactating women
  16. Patients with proteinuria (urine protein >1+ at screening, or urine protein 1+, not recover to normal value within 24h)
  17. Previously received anti-VEGF protein drugs, such as Bevacizumab, Sevacizumab
  18. 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.
  19. Participation in other clinical trials within 4 weeks before enrollment
  20. The investigators consider the patients are not suitable for this trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03763123
Other Study ID Numbers  ICMJE SIM-63-OC-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jiangsu Simcere Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jiangsu Simcere Pharmaceutical Co., Ltd.
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP