Second-line CM082 Combined With Paclitaxel For Patients With Advanced Gastric Cancer

NCT03286244 | Unknown Phase 1

• 1 other identifier: CM082-CA-I-104
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, Phase 1b study which will be conducted in two parts: part A is the dose escalation study while part B is dose expansion study. The purpose of the dose escalation part is to identify the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CM082 combined with paclitaxel in patients with advanced gastric cancer who did not respond to first-line standard chemotherapy. In the subsequent dose expansion part, additional subjects will be enrolled to further explore the safety and preliminary clinical activity of CM082 and paclitaxel.

Conditions

Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• DLT and MTD

  DLTs were defined as grade 4 hematological toxicity; grade 3 or more severe nonhematologic toxicity including nausea/vomit, constipation , Hypertension , not controlled by adequate supportive treatment (with exceptions of alopecia); grade 3 febrile neutropenia. The MTD was defined as the highest dose at which no DLT was experienced by the first 3 patients in that cohort, or the dose at which a DLT was experienced by no more than 1 of 6 patients evaluable for toxicity.

  4 weeks

• Percentage of patients who suffer at least one adverse event

  Adverse event assessment and changes in safety assessments include laboratory parameters, vital signs, and ECOG score

  From first dose to within 28 days after the last dose

Secondary Outcomes (2)

• Objective response rate

  12 weeks

• Progression-free survival

  6 months

Study Arms (1)

CM082 plus paclitaxel

EXPERIMENTAL

In dose-escalation part, patients will be treated in dose levels at the following daily doses of CM082 and paclitaxel to establish the MTD and RP2D: CM082 100mg qd + paclitaxel 80mg/m2/day; CM082 150mg qd + paclitaxel 80mg/m2/day; CM082 200mg qd + paclitaxel 80mg/m2/day; In dose-expansion part, patients will be treated at the RP2D established in dose escalation part.

Drug: CM082 plus paclitaxel

Interventions

CM082 plus paclitaxel DRUG

CM082 treatment: A treatment cycle is defined as 28 days. Oral CM082 tablets was given once daily for 3 weeks followed by 1-week break with escalating dose (100 mg, 150 mg and 200mg). Drug: Paclitaxel Paclitaxel 80 mg/m2 will be administrated by intravenous injection on days 1, 8, 15 of a 28-day cycle for no more than 6 cycles.

CM082 plus paclitaxel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully understand the study and sign the informed consent voluntarily;
• Patients with local advanced and/or metastatic gastric adenocarcinoma and/or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology;
• Progressed on previous first-line standard chemotherapy;
• Male or female with an age of 18-70 years(inclusive);
• Body weight ≥40 kg (inclusive);
• At least one measurable lesion (according to RECIST1.1);
• Performance status score (ECOG score) 0-1;
• Expected survival \>12 weeks;
• Adequate bonemarrow, liver, renal and cardiac function, based on blood tests, electrocardiograms, and cardiac echocardiograms.

You may not qualify if:

• Participating in another drug clinical trial in the past 4 weeks; history of systemic anti-tumor treatment within 4 weeks prior to administration of the study drug; history of any major surgery within 4 weeks prior to enrollment to the study;
• Who have not recovered from toxicity caused by previous anti-cancer treatment (CTCAE\>grade 1), or not completely recovered from previous surgery;
• Having received previous chemotherapy regimens with taxanes;
• Take medications that may extend QTc and/or Tdp;
• Active brain metastasis or meningeal metastasis;
• Uncontrolled hypertension (BP\>150/90 on medications);
• Other malignancies within the last 5 years, except for adequately treated cervix carcinoma in situ or basal or squamous-cell or basal cell carcinoma;
• QT interval \> 450 ms;
• Uncontrolled clinical active infection, e.g. acute pneumonia, active hepatitis B or hepatitis C; HIV positive; syphilitic spiral antibody positive;
• Dysphagia, intractable vomiting or known drug malabsorption;
• Drug or alcohol abuser.

Sponsors & Collaborators

• AnewPharma: lead

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, 100021, China

RECRUITING

MeSH Terms

Interventions

vorolanib; Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Aiping Zhou, MD

  National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

  STUDY CHAIR

Central Study Contacts

Aiping Zhou, MD

CONTACT

8610-87788800; zhouap1825@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 18, 2017
• Study Start: March 15, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2020
• Last Updated: February 21, 2019

Record last verified: 2019-02

Locations

CN (1)