Cancer
constitutes a heterogeneous group of disease whose clinical identification and
prognosis presents numerous challenges. The condition is much worse for
patients with refractory/recurrent/metastatic cancers, where the outcomes are
much poorer and cure is hardly a possibility. There is a substantial need for
developing screening methods to predict therapeutic effectiveness of drug
treatment regimens. A successful predictive method would provide maximum
benefits to patients while greatly enhancing the cost effectiveness and
efficiency of cancer treatment.
Mitra
Biotech Ltd. has developed CANScriptâ„¢ assay. CANScriptâ„¢ assay is a
multi-dimensional platform which enables challenging the patient’s own tumor
tissue against a number of drug combinations in a human-tumor microenviroment
that mimics tumors surroundings on an in
vitro plate. The test analyzes various parameters like cell viability, cell
proliferation, apoptosis and tumor morphology. The CANScriptTM
algorithm draws the results of various assays to arrive at a single predictive
score called the ‘M-Score’ for each drug/drug combination. Higher the M-Score,
greater is the tumor response to the drug.
In
the present protocol, Mitra Biotech and TMH intend to evaluate the applicability
of the “CANScript™†personalized preclinical tumor explant platform to
accurately forecast the therapeutic efficacy of candidate targeted drugs and
chemotherapeutics in patients with TNBCs and H&N Ca who present with tumors
that are clinically appropriate for biopsy.
The
study is an Observational Clinical Trial to reconfirm in a clinical setting the
specificity and sensitivity of CANScriptâ„¢ assay. The study will involve
classification of CANScriptâ„¢ assay results into responders & non-responders.
M> 25 is responder & M < 25 is non-responder. This is a non-randomized,
observational, investigator initiated trial. Head & Neck (H&N) and
Triple Negative Breast Cancer (TNBC) patients would be screened for eligibility
to be included in the study. Prior to initiating chemotherapy
patients would undergo a biopsy to obtain a tumor specimen and collection of
blood sample of patients enrolled in the study. These samples would be used for CANScriptTM
assay. The assay would be performed in vitro by using chemotherapeutic agents
that are part of standard of care at Tata Memorial Centre (TMC). Study patients would receive
chemotherapy that is part of the Standard of Care for that disease. Treatment decisions will always be
determined by the attending oncologist as per the standard of care practiced at
TMC. H&N cancer patients will
undergo 2 cycles of selected chemotherapy following which they will be
evaluated for response. Based on response, the Investigator may advice a 3rd
cycle of chemotherapy, after which the patients would again be evaluated for
response. On completion of the primary study chemotherapy the Investigator will
decide further course of local therapy as per standard of care in the form of
either: a. Surgery b. Radiation
therapy (RT) c. Chemo-Radio
Therapy (CTRT) d. Surgery
followed by either RT or CTRT H&N patients enter a long term
follow-up evaluation to be conducted every 90 days from last date of local
therapy upto maximum 2 years from the date of study enrollment. In the long
term follow up the patients would be evaluated for response to therapy
received, progression and survival. TNBC patients will receive 3 cycles
of chemotherapy following which they will be evaluated for response. Based on
the response, the Investigator will decide to continue the therapy up to 6
cycles following which the patients would be re-evaluated for response. In some
cases the patient may be further continued on some type of chemotherapy if so
considered by the treating physician. TNBC patients enter a long term
follow-up evaluation to be conducted every 90 days from last date of
chemotherapy up to maximum 2 years from the date of study enrollment. In the
long term therapy the patients would be evaluated for response to therapy
received, progression and survival. CANScriptTM assessment
will be carried out and completed in one week from the time tumor samples are
received from the patient. However, the Investigator would be blinded to the
results of the assay. The sponsor also would be blinded to the outcome of the
response to therapy. The results of the CANScriptTM
assay would be compared post un-blinding with the response that the subject
achieved as the Primary Objective Evaluation and with the time to progression
and death as the long term and Secondary Objective evaluation.
These
outcomes would be considered to establish the Specificity and Sensitivity of
the CANScriptTM assay in predicting outcome of chemotherapy.
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