NCT02797964 · OUTCOME

Disease Control Rate (DCR) of SRA737

A Phase 1/2 Trial of SRA737 in Subjects With Advanced Cancer · Source last updated 2023-06-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Radiographic tumor assessments were performed every 2 cycles of therapy.

What was measured

The disease control rate (DCR) was defined as the number of subjects achieving complete response (CR) + partial response (PR) + stable disease (SD) per RECIST 1.1 criteria. Since no subjects achieved CR or PR in this study, the DCR represents the proportion of subjects in each group who achieved SD.

Analysis population: The Response Evaluable Population (REP) included all enrolled subjects who satisfy all of the following conditions: 1. Measurable disease and assessment at baseline 2. Received at least 75% of 1 cycle of study medication, based on dosing information 3. At least one post baseline disease assessment OR discontinued treatment due to AE or disease progression or death

Groups in this outcome

Colorectal Cancer

Metastatic colorectal cancer (CRC) defined as histologically and/or cytologically confirmed CRC, and must have received at least 1 prior regimen for advanced/metastatic disease.

High Grade Serous Ovarian Cancer

High grade serous ovarian cancer (HGSOC) defined as histologically confirmed high grade serous ovarian, fallopian tube or primary peritoneal cancer who were recurrent platinum intolerant, or with platinum resistant disease defined as radiological evidence of disease progression within 6 months of the last receipt of platinum based chemotherapy.

Non Small Cell Lung Cancer

Advanced non small cell lung cancer (NSCLC) defined as locally advanced and recurrent or metastatic, histologically confirmed NSCLC, and must have received at least 1 prior regimen for advanced/metastatic disease.

Metastatic Other Tumor Type Castration Resistant Prostate Cancer

Metastatic castration resistant prostate cancer (mCRPC) defined as histologically or cytologically confirmed adenocarcinoma of the prostate that has progressed after androgen deprivation therapy.

Head and Neck Squamous Cell Carcinoma

Histologically confirmed HNSCC from any primary site; locally advanced disease (ie, persistent or progressive disease following curative intent radiation, and not a candidate for surgical salvage due to incurability or morbidity), or metastatic disease.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Colorectal Cancer	25
High Grade Serous Ovarian Cancer	26
Non Small Cell Lung Cancer	8
Metastatic Other Tumor Type Castration Resistant Prostate Cancer	13
Head and Neck Squamous Cell Carcinoma	4

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Colorectal Cancer	8	Not reported	Not reported	Not reported	Not reported
High Grade Serous Ovarian Cancer	11	Not reported	Not reported	Not reported	Not reported
Non Small Cell Lung Cancer	3	Not reported	Not reported	Not reported	Not reported
Metastatic Other Tumor Type Castration Resistant Prostate Cancer	8	Not reported	Not reported	Not reported	Not reported
Head and Neck Squamous Cell Carcinoma	3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
8
group Id
OG001
value
11
group Id
OG002
value
3
group Id
OG003
value
8
group Id
OG004
value
3

denoms

counts
group Id
OG000
value
25
group Id
OG001
value
26
group Id
OG002
value
8
group Id
OG003
value
13
group Id
OG004
value
4
units
Participants

description

groups

description
Metastatic colorectal cancer (CRC) defined as histologically and/or cytologically confirmed CRC, and must have received at least 1 prior regimen for advanced/metastatic disease.
id
OG000
title
Colorectal Cancer
description
High grade serous ovarian cancer (HGSOC) defined as histologically confirmed high grade serous ovarian, fallopian tube or primary peritoneal cancer who were recurrent platinum intolerant, or with platinum resistant disease defined as radiological evidence of disease progression within 6 months of the last receipt of platinum based chemotherapy.
id
OG001
title
High Grade Serous Ovarian Cancer
description
Advanced non small cell lung cancer (NSCLC) defined as locally advanced and recurrent or metastatic, histologically confirmed NSCLC, and must have received at least 1 prior regimen for advanced/metastatic disease.
id
OG002
title
Non Small Cell Lung Cancer
description
Metastatic castration resistant prostate cancer (mCRPC) defined as histologically or cytologically confirmed adenocarcinoma of the prostate that has progressed after androgen deprivation therapy.
id
OG003
title
Metastatic Other Tumor Type Castration Resistant Prostate Cancer
description
Histologically confirmed HNSCC from any primary site; locally advanced disease (ie, persistent or progressive disease following curative intent radiation, and not a candidate for surgical salvage due to incurability or morbidity), or metastatic disease.
id
OG004
title
Head and Neck Squamous Cell Carcinoma

param Type

COUNT_OF_PARTICIPANTS

population Description

The Response Evaluable Population (REP) included all enrolled subjects who satisfy all of the following conditions: 1. Measurable disease and assessment at baseline 2. Received at least 75% of 1 cycle of study medication, based on dosing information 3. At least one post baseline disease assessment OR discontinued treatment due to AE or disease progression or death

reporting Status

POSTED

time Frame

Radiographic tumor assessments were performed every 2 cycles of therapy.

title

Disease Control Rate (DCR) of SRA737

type

PRIMARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice