Status:
UNKNOWN
A Phase 1b Study of Sevacizumab in Combination With Chemotherapy in Chinese Patients With Platinum-Resistant Recurrent Ovarian Cancer.
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 combin...
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 combin...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
April 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03763123
Start Date
April 24 2018
End Date
December 31 2020
Last Update
December 4 2018
Active Locations (6)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
2
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
3
The first affiliated hospital,sun yat-sen university
Guangzhou, Guangdong, China
4
the Affiliated Cancer Hospital of Harbin Medical University
Harbin, Hei Longjiang, China