NCT02797964 · OUTCOME

Overall Survival (OS)

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: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: Follow-up assessments were made every 16 weeks for subjects who had not progressed and had not initiated new anticancer therapy.

What was measured

Overall survival (OS) was defined as time from Cycle 1 Day 1 to the date of death (or date last known to be alive). OS was analyzed using the K-M method.

Analysis population: The Response Evaluable Population (REP) included all subjects who satisfy 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 1 post baseline disease assessment OR discontinued treatment due to AE or disease progression or death Note: The median OS was not estimated in the mCRPC, HNSCC, or "Other" tumor type subgroups due to insufficient number of participants with events.

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 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.

Other Tumor Type

Any locally advanced or metastatic, histologically or cytologically proven solid tumor or NHL, that had relapsed after or progressing despite conventional treatment for which no conventional therapy was considered appropriate by the investigator or had been declined by the subject.

Overall

All subjects included in the Response Evaluable Population

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	24
High Grade Serous Ovarian Cancer	26
Non Small Cell Lung Cancer	8
Metastatic Castration Resistant Prostate Cancer	13
Head and Neck Squamous Cell Carcinoma	4
Other Tumor Type	8
Overall	81

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Colorectal Cancer	5.72	Not reported	4.14	NA	The upper 95% CI was not estimated due to insufficient number of participants with events
High Grade Serous Ovarian Cancer	6.93	Not reported	4.80	NA	The upper 95% CI was not estimated due to insufficient number of participants with events
Non Small Cell Lung Cancer	6.08	Not reported	0.49	NA	The upper 95% CI was not estimated due to insufficient number of participants with events
Metastatic Castration Resistant Prostate Cancer	NA	Not reported	NA	NA	The median and 95% CIs were not estimated due to insufficient number of participants with events
Head and Neck Squamous Cell Carcinoma	NA	Not reported	3.55	NA	The median and upper 95% CI were not estimated due to insufficient number of participants with events
Other Tumor Type	NA	Not reported	1.64	NA	The median and upper 95% CI were not estimated due to insufficient number of participants with events
Overall	6.93	Not reported	5.72	NA	The upper 95% CI was not estimated due to insufficient number of participants with events

Complete source fields

classes

categories
measurements
comment
The upper 95% CI was not estimated due to insufficient number of participants with events
group Id
OG000
lower Limit
4.14
upper Limit
NA
value
5.72
comment
The upper 95% CI was not estimated due to insufficient number of participants with events
group Id
OG001
lower Limit
4.80
upper Limit
NA
value
6.93
comment
The upper 95% CI was not estimated due to insufficient number of participants with events
group Id
OG002
lower Limit
0.49
upper Limit
NA
value
6.08
comment
The median and 95% CIs were not estimated due to insufficient number of participants with events
group Id
OG003
lower Limit
NA
upper Limit
NA
value
NA
comment
The median and upper 95% CI were not estimated due to insufficient number of participants with events
group Id
OG004
lower Limit
3.55
upper Limit
NA
value
NA
comment
The median and upper 95% CI were not estimated due to insufficient number of participants with events
group Id
OG005
lower Limit
1.64
upper Limit
NA
value
NA
comment
The upper 95% CI was not estimated due to insufficient number of participants with events
group Id
OG006
lower Limit
5.72
upper Limit
NA
value
6.93

denoms

counts
group Id
OG000
value
24
group Id
OG001
value
26
group Id
OG002
value
8
group Id
OG003
value
13
group Id
OG004
value
4
group Id
OG005
value
8
group Id
OG006
value
81
units
Participants

description

Overall survival (OS) was defined as time from Cycle 1 Day 1 to the date of death (or date last known to be alive). OS was analyzed using the K-M method.

dispersion Type

95% Confidence Interval

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 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
description
Any locally advanced or metastatic, histologically or cytologically proven solid tumor or NHL, that had relapsed after or progressing despite conventional treatment for which no conventional therapy was considered appropriate by the investigator or had been declined by the subject.
id
OG005
title
Other Tumor Type
description
All subjects included in the Response Evaluable Population
id
OG006
title
Overall

param Type

MEDIAN

population Description

The Response Evaluable Population (REP) included all subjects who satisfy 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 1 post baseline disease assessment OR discontinued treatment due to AE or disease progression or death Note: The median OS was not estimated in the mCRPC, HNSCC, or "Other" tumor type subgroups due to insufficient number of participants with events.

reporting Status

POSTED

time Frame

Follow-up assessments were made every 16 weeks for subjects who had not progressed and had not initiated new anticancer therapy.

title

Overall Survival (OS)

type

PRIMARY

unit Of Measure

months

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Preserved source evidence · Not medical advice