The 22nd SEC (Oncology& hematology) meeting deliberated the proposals on and recommended the following:- volunteers.

Transcription

1 :- The 22nd SEC (Oncology& hematology) meeting deliberated the proposals on and recommended the following:- Agenda 1 peg-gcsf 4-270/Biocon Ltd./14 BD 2 Trastuzumab 4-237/Dr. Reddy/14-BD 3 GCSF 4-258/QPSBio/14- BD 4 peg-gcsf 4-259/QPSBio/14- BD GCT Proposals 5 PF /rituxi mab CT/36/14 Biocon Pvt. Ltd Dr. Reddy s Laboratories QPS bioserve India Pvt. Ltd. QPS bioserve India Pvt. Ltd Pfizer Ltd Biological proposals recommended for the proposed PK/PD study of indigenously developed PEG-GCSF in healthy volunteers. recommended for the proposed Phase I/III clinical study of indigenously developed trastuzumab. recommended for the proposed PK/PD study in healthy volunteers. recommended for the proposed PK/PD study in healthy volunteer, with a condition that, there should be Wash out period of 28 days. Accordingly revised protocol should be submitted to this office after which final approval may be granted. pharmacology, single dose, repeated dose toxicity studies and clinical PK/PD, phase I/II studies justify the conduct of this study. purpose of the study is tocompare the efficacy of rituximab-pfizer to rituximab-eu when administered as a first-line treatment to patients with CD20-positive, low tumour burden, follicular lymphoma (LTB-FL). potentially provide alternative treatment to patients with CD20-positive, low tumour burden, follicular lymphoma (LTB-FL). 6 Masitinib CT/42/14 Maya clinic the conduct of the trial. After detailed deliberation the committee opined that since the standard of care possible in GIST is imatinib in adjuvant setting, the present protocol which compares masitinib to placebo needs to be modified. The comparator arm should include only patients not tolerating imatinib not Page 1 of 5

2 those who do not have access to imatinb. Accordingly revised protocol should be submitted for further review. 7 Plasma derived fibrinogen CT/43/14 Max Neeman pharmacology, general toxicity, single dose, immunogenicity toxicity justify 8 Gemcitabine + Capecitabine CT/61/13 9 Ofatumumab CT/743/09 Dr.ShaileshS hrikhande,ta ta memorial hospital GSK purpose of the study is to evaluate the Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Patients with Congenital Afibrinogenaemia. potentially provide alternative treatment option in Patients with Congenital Afibrinogenaemia. the conduct of the trial. Assessment of Risk vs. Benefit to the patients: In light of the fact that the test drugs are already approved in India, the safety profile of the drugs justify the conduct of the trial. purpose of the study is to compare combination of Gemcitabine and Capecitabine therapy with Gemcitabine alone in patients with either pancreatic ductal adrenocarcinoma or peri-ampullary carcinoma who have undergone curative resection. potentially provide alternative treatment option for pancreatic ductal adrenocarcinoma or peri-ampullary carcinoma who have undergone curative resection. After deliberation the committee recommended for the conduct of the trial. pharmacology, general toxicity, Single dose toxicity, repeated dose toxicity and phase I and II clinical trials justify purpose of the study is to to evaluate and compare Page 2 of 5

3 progression free survival of subjects treated with study drug added to fludarabine and cyclophosphamide for the treatment of relapsed chronic lymphocytic leukemia to those treated with fludarabine and cyclophosphamide. potentially provide alternative treatment option for patients with relapsed chronic lymphocytic leukemia. After detailed deliberation the committee recommended protocol amendment 1(appendix 2 times and events only anti-cancer and anti-infectious treatments will be followed after 1 M FUP if associated with SAE, until subsequent anti-cll therapy is initiated) but other part of protocol amendment 1(section time period and frequency for detecting AEs and SAEs SAE no longer reported after commencement of anti-cll therapy)is not recommended. All SAEs to be continually reported till the end of the trial. The committee also recommended protocol amendment LEE011 CT/47/14 vartis pharmacology, general toxicity, single dose, repeat dose toxicity, genotoxicity and phase I,II clinical studies, justify purpose of the study is to estimate the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of the combination of letrozole and LEE011 in postmenopausal patients with HR+/HER2-negative advanced breast cancer. potentially provide alternative option for the treatment of postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer. conduct of the trail. 11 LEE011 CT/51/14 vartis pharmacology, general toxicity, single dose, repeat dose toxicity, genotoxicity and phase I, II clinical studiesjustify purpose of the study to determine whether treatment Page 3 of 5

4 tamoxifen or a NSAI + goserelin + LEE011 prolongs PFS compared to treatment with tamoxifen or a NSAI + goserelin + placebo in premenopausal women with HR + HER2-negative advanced breast cancer potentially provide alternative option for the treatment of premenopausal women with hormone receptor positive, HER2- negative, advanced breast cancer. conduct of the trail with the subject to the condition that pre-clinical reproductive toxicity data shall be submitted to this Directorate before final approval. 12 Trastuzumabbios imilar CT/03/14 13 Buparlisib CT/67/13 ManipalAccu nova vartis Risk versus benefit to the patients The safety profile of the test drug from preclinical pharmacology, repeat dose toxicity studies and phase I clinical trials justify Innovation vis-a-vis existing therapeuticoption- Trastuzumab is a high-end monoclonal antibody. The purpose of the study is to demonstrate comparable clinical efficacy of the test drug with that of the innovator product in Her2 + MBC in neo- adjuvant setting. Unmet medical need in the country Multisource availability of trastuzumab may benefit Indian patients. After detailed deliberation the committee recommended protocol amendment 04( Additional subjects) pharmacology, general toxicity, single dose, repeated dose toxicity studies, Genotoxicity studies, Phototoxicity studies Reproductive toxicity, phase I and IIclinical trials justify purpose of the study is to estimate the efficacy of buparlisib I combination with paclitaxel and to assess the efficacy of the combination with paclitaxel in this patient population in terms of overall survival. Unmet Medical Need in the country:the test drug may potentially provide alternative treatment option for patients with recurrent or metastatic head and neck squamous cell carcinoma. Page 4 of 5

5 After detailed deliberation the committee recommended the protocol amendment 1. Page 5 of 5