Trial · NCT02797964

A Phase 1/2 Trial of SRA737 in Subjects With Advanced Cancer

NCT02797964, Phase 1, Phase 2, Completed, Sierra Oncology LLC - a GSK company; results first posted 2022-03-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 1/2 Trial of SRA737 in Subjects With Advanced Cancer. Trials, record NCT02797964. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02797964

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase 1/2 Trial of SRA737 in Subjects With Advanced Cancer
NCT number: NCT02797964
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 107 participants, actual
Lead sponsor: Sierra Oncology LLC - a GSK company
Conditions: Advanced Solid Tumors or Non-Hodgkin's Lymphoma (NHL)
Interventions: SRA737
First posted: 2016-06-14
Last updated: 2023-06-18
Results first posted: 2022-03-10

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Subjects With Adverse Events as Assessed by CTCAE 4.03	Up to 30 days after last dose of SRA737	Treatment-emergent adverse events (TEAEs) were reported until the safety Follow up (SFU) visit, 30 days after the last dose of SRA737 or prior to the initiation of a new anticancer treatment, whichever came first.
Primary	Maximum Tolerated Dose of SRA737	Cycle 1 (28 days) in the Dose Escalation Phase	The highest dose at which ≤ 33% of subjects have a dose limiting toxicity (DLT) in a cohort of up to 6 subjects.
Primary	Recommended Phase 2 Dose of SRA737	Up to 30 days after last dose of SRA737	The RP2D and schedule were defined by the Cohort Review Committee at the end of the study and took all clinically relevant toxicity, PK and PDn data into account. The RP2D was to be a dose equal to or less than the MTD for the selected schedule.
Primary	Disease Control Rate (DCR) of SRA737	Radiographic tumor assessments were performed every 2 cycles of therapy.	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.
Primary	Time to Progression (TTP)	Radiographic tumor assessments were performed every 2 cycles of therapy. Follow-up assessments were made every 16 weeks for subjects who had not progressed and had not initiated new anticancer therapy.	Time to progression (TTP) was defined as the time from Cycle 1 Day 1 to the earliest date of radiographic disease progression per RECIST 1.1, or if the subject did not experience disease progression, to the last imaging assessment. TTP was analyzed using the K-M method.
Primary	Progression Free Survival (PFS)	Radiographic tumor assessments were performed every 2 cycles of therapy. Follow-up assessments were made every 16 weeks for subjects who had not progressed and had not initiated new anticancer therapy.	Progression free survival (PFS) was defined as time from Cycle 1 Day 1 to the earliest date of radiographic disease progression per RECIST 1.1 or death, whichever happened first. Censoring rules are defined in the SAP. PFS was analyzed using the K-M method.
Primary	Overall Survival (OS)	Follow-up assessments were made every 16 weeks for subjects who had not progressed and had not initiated new anticancer therapy.	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.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects With Adverse Events as Assessed by CTCAE 4.03	Up to 30 days after last dose of SRA737	As specified in the Statistical Analysis Plan, the frequency of each AE was evaluated in the overall Safety Evaluable Population rather than by tumor type subgroups with the intention of displaying the overall safety profile of SRA737 in advanced solid tumors. The Safety Evaluable Population includes all enrolled subjects who receive at least 1 dose of SRA737.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Maximum Tolerated Dose of SRA737	Cycle 1 (28 days) in the Dose Escalation Phase	In order to determine the MTD, a total of 18 subjects were enrolled in the dose escalation phase of the study in 9 dosage cohorts. All subjects receiving at least 75% of planned doses of SRA737 within Cycle 1 and those subjects receiving less than these planned doses of SRA737 due to DLT were considered evaluable for dose review decisions.	mg QD	NUMBER
PRIMARY	Recommended Phase 2 Dose of SRA737	Up to 30 days after last dose of SRA737	All 107 subjects treated in the study were included in the review of toxicity, PK and PDn, data in order to determine the RP2D. All clinically relevant toxicity, PK and PDn data up to 30 days after last dose of SRA737 were taken into account.	mg QD	NUMBER
PRIMARY	Disease Control Rate (DCR) of SRA737	Radiographic tumor assessments were performed every 2 cycles of therapy.	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	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Time to Progression (TTP)	Radiographic tumor assessments were performed every 2 cycles of therapy. Follow-up assessments were made every 16 weeks for subjects who had not progressed and had not initiated new anticancer therapy.	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	months	MEDIAN
PRIMARY	Progression Free Survival (PFS)	Radiographic tumor assessments were performed every 2 cycles of therapy. Follow-up assessments were made every 16 weeks for subjects who had not progressed and had not initiated new anticancer therapy.	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	months	MEDIAN
PRIMARY	Overall Survival (OS)	Follow-up assessments were made every 16 weeks for subjects who had not progressed and had not initiated new anticancer therapy.	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.	months	MEDIAN

Source ClinicalTrials.gov

Results by group25

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Subjects With Adverse Events as Assessed by CTCAE 4.03	Safety Evaluable Population	106		Participants
Maximum Tolerated Dose of SRA737	Dose Escalation Phase	1000		mg QD
Recommended Phase 2 Dose of SRA737	Safety Evaluable Population	800		mg QD
Disease Control Rate (DCR) of SRA737	Colorectal Cancer	8		Participants
Disease Control Rate (DCR) of SRA737	High Grade Serous Ovarian Cancer	11		Participants
Disease Control Rate (DCR) of SRA737	Non Small Cell Lung Cancer	3		Participants
Disease Control Rate (DCR) of SRA737	Metastatic Other Tumor Type Castration Resistant Prostate Cancer	8		Participants
Disease Control Rate (DCR) of SRA737	Head and Neck Squamous Cell Carcinoma	3		Participants
Time to Progression (TTP)	Colorectal Cancer	1.87	95% Confidence Interval 1.68 to 3.06	months
Time to Progression (TTP)	High Grade Serous Ovarian Cancer	1.94	95% Confidence Interval 1.81 to 3.68	months

1 to 10 of 25Source ClinicalTrials.gov

See all 25 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Colorectal Cancer	32
Overall Study	STARTED	High Grade Serous Ovarian Cancer	37
Overall Study	STARTED	Non Small Cell Lung Cancer	10
Overall Study	STARTED	Metastatic Other Tumor Type Castration Resistant Prostate Cancer	16
Overall Study	STARTED	Head and Neck Squamous Cell Carcinoma	4
Overall Study	STARTED	Other Tumor Type	8
Overall Study	COMPLETED	Colorectal Cancer	32
Overall Study	COMPLETED	High Grade Serous Ovarian Cancer	37
Overall Study	COMPLETED	Non Small Cell Lung Cancer	10
Overall Study	COMPLETED	Metastatic Other Tumor Type Castration Resistant Prostate Cancer	16

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events94

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	Safety Evaluable Population	74	107	131
other	Nausea	Gastrointestinal disorders	Safety Evaluable Population	72	107	125
other	Vomiting	Gastrointestinal disorders	Safety Evaluable Population	56	107	94
other	Constipation	Gastrointestinal disorders	Safety Evaluable Population	19	107	26
other	Abdominal pain	Gastrointestinal disorders	Safety Evaluable Population	17	107	23
other	Abdominal distension	Gastrointestinal disorders	Safety Evaluable Population	11	107	17
other	Dyspepsia	Gastrointestinal disorders	Safety Evaluable Population	10	107	11
other	Abdominal pain upper	Gastrointestinal disorders	Safety Evaluable Population	7	107	7
other	Ascites	Gastrointestinal disorders	Safety Evaluable Population	6	107	7
other	Gastrooesophageal reflux disease	Gastrointestinal disorders	Safety Evaluable Population	6	107	6

1 to 10 of 94Source ClinicalTrials.gov

See all 94 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Safety Evaluable Population	18	107
Total, other adverse events	Safety Evaluable Population	106	107
Total, serious adverse events	Safety Evaluable Population	48	107

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34665631	DERIVED	PubMed
37120671	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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