A clinical trial to study the effects of two drugs, R-TPR-033 and Erbitux® in patients with head and neck cancer of squamous cell type that has spread to other part of the body

Phase 3

• Conditions: Patients with recurrent loco regional or metastatic squamous cell carcinoma of the head and neck.

• Registration Number: CTRI/2015/06/005909
• Lead Sponsor: Reliance Life Sciences Pvt Ltd

Brief Summary

This is a prospective, multi-centre, open-label, two-arm, parallel group, active-control, randomized comparative clinical study. The present study will evaluate the efficacyxml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

safety and pharmacokinetics of *R-TPR-033* and Erbitux in patients with recurrent loco regional or metastatic squamous cell carcinoma of the head and neck.

The primary outcome measures will be to assess the efficacy as Best overall response rate assessed by RECIST 1.1 criteria

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-25
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• 1.Patients of 18-65 years of age.
• 2.Histologically or cytologically confirmed recurrent locoregional or metastatic squamous-cell carcinoma of the head and neck that is not suitable for local therapy 3.Patients must have documented progression of platinum-based chemotherapy for R/M disease 4.At least one lesion that is measurable by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 5.Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• 6.Estimated life expectancy >4 months 7.ANC ≥1.5x109/L, Platelets ≥100x109/L, Hemoglobin >9.0 g/dL, Serum Creatinine ≤ 1.5 ULN and Total bilirubin ≤ 1.5 mg/dL.
• 8.INR and aPTT ≤1.5× ULN.
• 9.Serum creatinine ≤1.5× ULN, or creatinine clearance ≥50 mL/min 10.Patient or Legally Acceptable Representative able to comprehend and give written informed consent for the study and willing to come for follow-up visits as per protocol requirements.

Exclusion Criteria

• Nasopharyngeal cancer 2.
• Prior treatment with an investigational or approved agent for the purpose of inhibiting HER family members 3.
• Last anti-tumor therapy within 4 weeks before Cycle 1, Day 1.
• Diagnosis of concurrent second malignancy or leukemia 5.
• Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs 6.
• Symptomatic hypercalcemia.
• History of bleeding diathesis or coagulopathy other than that due to anticoagulation therapy 8.
• Active hemoptysis 9.
• Clinically significant gastrointestinal bleeding within 6 months prior to Cycle 1 10.
• History of Interstitial Lung Disease 11.
• Major surgical procedure or significant traumatic injury within approximately 28 days prior to randomization 14.
• Severe dyspnoea 15.
• Pre-existing grade 2 or greater motor or sensory neuropathy 16.
• Women who are pregnant, lactating, or women of childbearing potential who are not using effective contraception.
• Serious underlying medical condition.
• Subject participation in another clinical trial within 90 days prior to administration of IP.
• Current severe, uncontrolled acute or chronic systemic disease Any other condition which investigator feels would pose a significant hazard to subject, if IP is administered.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome Name: Efficacy will be assessed as BOR (Best Overall Response) by RECIST 1.1 criteria	week 18

Secondary Outcome Measures

Name	Time	Method
•To assess efficacy as Disease Control Rate	•To determine disease progression free survival (PFS) rate

Trial Locations

Locations (14)

B.J. Govt Medical College; 🇮🇳 Pune, MAHARASHTRA, India

Curie Manavata Cancer Institute; 🇮🇳 Nashik, MAHARASHTRA, India

Dr. Baraskar Hospital and Cancer Care Center; 🇮🇳 Nagpur, MAHARASHTRA, India

G Kuppuswamy Naidu Memorial Hospital; 🇮🇳 Coimbatore, TAMIL NADU, India

Government Medical College & Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

HCG Cancer Centre; 🇮🇳 Ahmadabad, GUJARAT, India

Karnataka cancer Hospital & Research Centre; 🇮🇳 Bangalore, KARNATAKA, India

KR Medical College & Hospital, Mysore Medical College and Research Institute; 🇮🇳 Mysore, KARNATAKA, India

Meenakshi Mission Hospital & Research Centre; 🇮🇳 Madurai, TAMIL NADU, India

MNJ Institute of Oncology & Regional Cancer Centre; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

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B.J. Govt Medical College

🇮🇳Pune, MAHARASHTRA, India

Dr Jadhav Kirankumar

Principal investigator

9823949126

drkpjadhav@gmail.com