Health Condition 1: null- Non-resectable metastatic colorectal cancer (mCRC) and recurrent or advanced non-squamous non-small cell lung cancer (NSCLC)
Conditions
Interventions
Intervention1: DRL_BZ (Bevacizumab): Part A:
DRL_BZ, 5 mg/kg administered intravenously (i.v.) on day 1 as a 90 min infusion with the needed adjustments every two weeks in conjunction with mFOLFOX6. P
15 mg/kg administered intravenously (i.v.) on day 1 every three weeks plus pemetrexed+carboplatin chemotherapy for 4 cycles. After 4 cycles, treatment will be continued with bevacizumab and pemetrexed
Sponsors
Dr Reddys Laboratories Ltd
DiagnoSearch Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • Age >=18 years • Written informed consent • Histologically/ cytologically confirmed mCRC (St IV, at least M1) - First line treatment (tt) for metastatic disease • Measurable disease (RECIST version 1.1) • Life expectancy >= 3 months; ECOG: 0 - 2 • No scheduled/planned RT or surgery during the course of the study. • At least 4 weeks and complete recovery from the effects of surgery, with complete wound healing • Adequate bone marrow function, haematological parameters, liver function, and renal function. Normal coagulation profile • Appropriate and proper contraception measures by females of child bearing potential
Exclusion criteria
Exclusion criteria: • Prior use of bevacizumab/ another mAb in the past 6 months • Potentially resectable metastatic disease • Prior chemotherapy or other systemic therapy for mCRC • CNS metastases • Allergy or hypersensitivity to bevacizumab, 5-FU, oxaliplatin, leucovorin/ any excipient(s). • Neurosensory disorder/ symptomatic peripheral neuropathy (>=Gr 1 CTCAE) • H/O any other malignancy within 5 yrs (except non-melanoma skin cancer or carcinoma-in-situ of the cervix, or resected intra-ductal breast cancer) • Any clinically significant CVS disease/ lung disease • Clinically relevant non-neoplastic CNS disease • Patients with organ allografts requiring immunosuppressive therapy. • Evidence of bleeding diathesis/ coagulopathy including current anticoagulant/ anti-platelet aggregant treatment (except Aspirin up to 325 mg/day); or any H/O CNS haemorrhage. • Major surgery/trauma within previous 28 days • Minor procedures in the week before screening/ not completely recovered from a prior minor procedure at the time of screening. • Non-healed fracture • Haemoptysis/ other clinically relevant haemorrhage in the 28 days before IP administration / conditions with major risk of bleeding • H/O abdominal fistula, gastrointestinal perforation, diverticulitis/intra-abdominal abscess within 6 months before enrolment or any chronic gastrointestinal disease causing diarrhoea of a severity >1 CTCAE • Any H/O inflammatory bowel disease/ active gastroduodenal ulcer within 4 weeks prior to screening. • Patients requiring prolonged treatment with NSAIDs (except Aspirin up to 325 mg/day as an anti- platelet aggregant therapy). • Clinically detectable ascites. • Known dihydropyrimidine dehydrogenase deficiency. • Uncontrolled systemic diseases including active infection. • Known hepatitis C, hepatitis B, HIV infection. HBsAg positive status. • Any other medical/ psychiatric condition which may affect the patientâ??s safety or study participation and conduct. • Previous exposure to any investigational agent within 4 weeks (6 months for monoclonal antibodies)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PART A: To compare the efficacy measured in terms of progression free survival at 9 months (PFS9) of two anti-VEGF antibodies administered in combination with chemotherapy for mCRC (stage IV) as first-line treatment for metastatic disease. PART B: To compare the efficacy measured in terms of progression free survival at 6 months (PFS6) of two anti-VEGF antibodies administered in combination with chemotherapy for recurrent or advanced non-squamous NSCLC not previously treated with chemotherapy.Timepoint: 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| PART A: To compare the efficacy measured in terms of progression free survival at 6 months (PFS6) of DRL_BZ and RMP administered in combination with chemotherapy for mCRC as well as to assess safety, tolerability and immunogenicity of DRL_BZ. PART B: To assess overall Response Rate, Disease Control Rate and Incidence of adverse events, including infusion reactions, proportions of patients with anti-bevacizumab immune responses. Pharmacokinetic parameters: Cmax, AUC0-t, AUC0-tau Timepoint: 6 Months | — |
Countries
India
Contacts
Public ContactRanjith K
Dr. Reddyâ??s Laboratories Ltd.
Outcome results
None listed