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Apatinib Plus Docetaxel Versus Docetaxel as Second-line Treatment in Advanced Gastric Cancer (AHEAD-301)

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ClinicalTrials.gov Identifier: NCT02596256
Recruitment Status : Active, not recruiting
First Posted : November 4, 2015
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Dai, Guanghai, Chinese PLA General Hospital

Brief Summary:
Apatinib plus docetaxel versus docetaxel as second-line treatment in advanced gastric cancer.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Apatinib Drug: Docetaxel Phase 2

Detailed Description:
This trial investigated the safety and efficacy of apatinib plus docetaxel, as a treatment option for heavily pretreated patients with advanced gastric cancer.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Apatinib Plus Docetaxel Versus Docetaxel as Second-line Treatment in Advanced Gastric Cancer Stage II Randomized Controlled Clinical Studies
Study Start Date : April 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: control group
Apatinib Mesylate Tablets (500 mg qd p.o.) and Docetaxel (60mg/m2 i.v. d1 q21d)
Drug: Apatinib
Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity
Other Name: ATAN

Drug: Docetaxel
Docetaxel (60 mg/m2 qd d1 q3w i.v.) until disease progression or intolerable toxicity

Active Comparator: contrast group
Docetaxel (60mg/m2, i.v. d1 q21d)
Drug: Docetaxel
Docetaxel (60 mg/m2 qd d1 q3w i.v.) until disease progression or intolerable toxicity




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: more than 18 years old, male or female;
  2. Pathologically diagnosed with advanced gastric cancer (including adenocarcinoma of the gastroesophageal junction) with measurable metastases outside the stomach (measuring ≥ 10mm on spiral computed tomography(CT) scan, satisfying the criteria in Response Evaluation Criteria In Solid Tumors (RECIST) 1.1);
  3. Failure of prior therapy (during or after treatment) in patients who have received at first line chemotherapy regimens(platinum - based regimens);
  4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1;
  5. Major organ function has to meet the following criteria; (1) For results of blood routine test and biochemical tests:

    1. Hemoglobin (HB) ≥ 80g / L,
    2. ANC ≥ 1.5 × 109 / L,
    3. PLT ≥ 90 × 109 / L,
    4. ALT and AST ≤ 2.5 × ULN, liver metastases, if any, the ALT and AST≤5 × ULN,
    5. Bilirubin ≤ 1.5 times the upper limit of normal (ULN),
    6. Serum creatinine ≤ 1.5 times the upper limit of normal (ULN),
    7. Serum albumin ≥ 30g / L;
  6. An expected survival of ≥ 3 months;
  7. Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug;
  8. Patient has to voluntarily join the study and sign the Informed Consent Form for the study.

Exclusion Criteria:

  1. Confirmed that apatinib and/or its accessories allergy;
  2. Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than Class Ⅰ; Ⅰ-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class Ⅰ cardiac dysfunction; Patients with positive urinary protein;
  3. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
  4. Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months;unresected primary lesion in stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with massive alimentary tract bleeding risk judged by PIs based on gastric endoscopy result;
  5. Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;
  6. Associated with CNS (central nervous system) metastases;
  7. Pregnant or lactating women;
  8. Pts with other malignant tumor within 5 years;
  9. With psychotropic drug abuse history and can't get rid of or mental disorder patients;
  10. Participated in other clinical trials within 4 weeks;
  11. Pts received VEGFR inhibitor treatment(i.e. sorafenib, sunitinib);
  12. Any other condition that might place the patient at undue risk or preclude a patient from completing the study;
  13. Other conditions regimented at investigators' discretion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596256


Locations
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China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital

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Responsible Party: Dai, Guanghai, Department Director, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02596256     History of Changes
Other Study ID Numbers: AHEAD-301
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Apatinib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors