A study of Docetaxel Lipid Suspension for Injection in stomach cancer patients

Phase 4

• Conditions: Health Condition 1: C169- Malignant neoplasm of stomach, unspecified

• Registration Number: CTRI/2018/01/011450
• Lead Sponsor: Intas Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patient willing and able to give informed consent to participate in the study

2. Male and Female patients 18-70 years (both inclusive) at screening

3. Patient with confirmed metastatic gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease

4. Patient should have at least one measurable lesion as per RECIST 1.1

5. Patient must have an adequate bone marrow, renal, cardiac and hepatic function

6. Patient should be able to comply with study procedures in the opinion of the investigator

7. Patient with a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG)

8. Patient with Life expectancy more than six months

9. Serum pregnancy test at screening and urine pregnancy test on Day 01(before dosing) of each cycle must be negative

10. Male or Female patients or their partner/s must agree to use effective measures of contraception during the study. Male patients should agree to use effective contraceptive method at least for 6 months after the end of treatment

Exclusion Criteria

1. Patient with the history of hypersensitivity reactions to Taxanes or any other component of formulation

2. Chronic treatment with systemic steroids or another immunosuppressive agents or patient with severely immunocompromised state

3. Patients with an active, severe infection (e.g., tuberculosis, sepsis and opportunistic infections)

4. Patient with known CNS lesions (brain metastasis or carcinomatous meningitis)

5. Any history or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease or any other condition which in the opinion of the investigator could jeopardize the safety of the subject or the validity of the study results

6. Significant peripheral neuropathy

7. Concurrent malignancy or history of malignancy within last 5 years before screening except curatively treated carcinoma in situ of the uterine cervix or basal cell carcinoma of the skin

8. Major surgery within last 3 weeks before screening

9. Radiotherapy within last 6 weeks before screening

10. Any other experimental drugs within a 4 week period prior to start of chemotherapy

11. Patients with hepatitis B, hepatitis C or HIV infection

12. Pregnant or breast-feeding patients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the Efficacy of DoceAqualip 20/80 (Docetaxel Lipid Suspension for Injection) in Patients with Metastatic Gastric AdenocarcinomaTimepoint: Visit 1, Visit 11, Visit 20, Visit 21, Visit 22, Visit 23

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability of DoceAqualip 20/80 (Docetaxel Lipid Suspension for Injection) in Patients with Metastatic Gastric AdenocarcinomaTimepoint: Visit 1 to Visit 23