Trial · NCT01137071

Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer

NCT01137071, Phase 2, Terminated, Recepta Biopharma; results first posted 2016-12-29

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer. Trials, record NCT01137071. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01137071

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Trial

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

Title: Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
NCT number: NCT01137071
Status: Terminated
Phases: Phase 2
Enrollment: 29 participants, actual
Lead sponsor: Recepta Biopharma
Conditions: Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
Interventions: Monoclonal antibody Hu3S193
First posted: 2010-06-04
Last updated: 2017-02-23
Results first posted: 2016-12-29

Source ClinicalTrials.gov

Registered outcomes58

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

List	Outcome	Time frame	Description
Primary	1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy	1-Year - From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first.	PFS2 is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period. Disease progression is defined by appearance of any new lesion (measurable and non-measurable) by the RECIST criteria. Disease progression date is the date when a new lesion is documented.
Secondary	1-year Disease Progression-free Survival Rate	1 year from the beginning of platinum-based rescue chemotherapy start date
Secondary	Two-year Overall Survival Rate	2-year overall survival rate after the beginning of rescue platinum-based chemotherapy.	Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.
Secondary	Safety - Vital Signs - Heart Rate	Baseline, week 2 , week 4 and week 27	Vital signs were assessed throughout the study treatment (consolidation therapy).Through study completion, an average of 27 weeks.
Secondary	Safety - Vital Signs - Respiratory Rate	Baseline, week 2, week 4 and week 27	Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
Secondary	Safety - Vital Signs - Systolic and Diastolic Blood Pressure	Baseline, week 2, week 4 and week 27	Both parameters were assessed throughout the study treatment. Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
Secondary	Safety - Vital Signs - Temperature	Baseline, week 2, week 4 and week 27	Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
Secondary	Incidence of Adverse Events (AEs) - Gastrointestinal Disorders	From the first infusion of medication to 30 days after the last one	The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Secondary	Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions	From the first infusion of medication to 30 days after the last one	The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Secondary	Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders	From the first infusion of medication to 30 days after the last one	The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

1 to 10 of 58Source ClinicalTrials.gov

See all 58 registered outcomes

Outcomes58

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy	1-Year - From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first.	In the ITT (intention to treat) population, 25 patients out of the 29 considered for the PFS2 analysis presented disease progression or death and 4 were censored. The median time to disease progression or death was 11.8 months (95% CI (confidence interval), 10.6 to 13.9 months).	Months	MEDIAN
SECONDARY	1-year Disease Progression-free Survival Rate	1 year from the beginning of platinum-based rescue chemotherapy start date	In the ITT (Intention-to-treat) population, 25 patients out of the 29 considered for the PFS2 analysis presented disease progression or death and 4 were censored.	percentage of participants	NUMBER
SECONDARY	Two-year Overall Survival Rate	2-year overall survival rate after the beginning of rescue platinum-based chemotherapy.	Within the ITT population, 7 patients died and 22 were censored. The 2-year overall survival rate was 70.7%.	percentage of participants	NUMBER
SECONDARY	Safety - Vital Signs - Heart Rate	Baseline, week 2 , week 4 and week 27	All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) - ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14	bpm	MEDIAN
SECONDARY	Safety - Vital Signs - Respiratory Rate	Baseline, week 2, week 4 and week 27	All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) - ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14	ipm (Incursions per minute)	MEDIAN
SECONDARY	Safety - Vital Signs - Systolic and Diastolic Blood Pressure	Baseline, week 2, week 4 and week 27	All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) - ITT dataset. Diastolic Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14/ Systolic Baseline n=28, week 2 n=27, week 4 n= 28, week 27 n= 14	mmHg	MEDIAN
SECONDARY	Safety - Vital Signs - Temperature	Baseline, week 2, week 4 and week 27	All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) - ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14	°C	MEDIAN
SECONDARY	Incidence of Adverse Events (AEs) - Gastrointestinal Disorders	From the first infusion of medication to 30 days after the last one	All patients who received at least one dose of investigational product were included in the safety dataset.	Incidence	NUMBER
SECONDARY	Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions	From the first infusion of medication to 30 days after the last one	All patients who received at least one dose of investigational product were included in the safety dataset.	Incidence	NUMBER
SECONDARY	Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders	From the first infusion of medication to 30 days after the last one	All patients who received at least one dose of investigational product were included in the safety dataset.	Incidence	NUMBER

1 to 10 of 58Source ClinicalTrials.gov

See all 58 outcomes

Results by group113

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

Outcome	Group	Category	Value	Spread	Units
1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy	hu3S193		11.7614	95% Confidence Interval 10.5902 to 13.9251	Months
1-year Disease Progression-free Survival Rate	hu3S193		48.2		percentage of participants
Two-year Overall Survival Rate	hu3S193		70.7		percentage of participants
Safety - Vital Signs - Heart Rate	hu3S193	Baseline	78.00	Standard Deviation 12.11	bpm
Safety - Vital Signs - Heart Rate	hu3S193	Week 2	80.00	Standard Deviation 11.49	bpm
Safety - Vital Signs - Heart Rate	hu3S193	Week 4	76.00	Standard Deviation 10.58	bpm
Safety - Vital Signs - Heart Rate	hu3S193	Week 27	75.00	Standard Deviation 9.84	bpm
Safety - Vital Signs - Respiratory Rate	hu3S193	Baseline	19.00	Standard Deviation 2.10	ipm (Incursions per minute)
Safety - Vital Signs - Respiratory Rate	hu3S193	Week 2	19.00	Standard Deviation 1.62	ipm (Incursions per minute)
Safety - Vital Signs - Respiratory Rate	hu3S193	Week 4	19.00	Standard Deviation 1.59	ipm (Incursions per minute)

1 to 10 of 113Source ClinicalTrials.gov

See all 113 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	hu3S193	29
Overall Study	COMPLETED	hu3S193	15
Overall Study	NOT COMPLETED	hu3S193	14

Source ClinicalTrials.gov

Adverse events40

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	Nausea	Gastrointestinal disorders	hu3S193	19	29	69
other	Vomiting	Gastrointestinal disorders	hu3S193	17	29	64
other	Abdominal pain	Gastrointestinal disorders	hu3S193	9	29	16
other	Constipation	Gastrointestinal disorders	hu3S193	7	29	10
other	Diarrhoea	Gastrointestinal disorders	hu3S193	6	29	8
other	Abdominal pain upper	Gastrointestinal disorders	hu3S193	3	29	3
other	Dry mouth	Gastrointestinal disorders	hu3S193	2	29	2
other	Dyspepsia	Gastrointestinal disorders	hu3S193	2	29	2
other	Influenza like illness	General disorders	hu3S193	8	29	9
other	Fatigue	General disorders	hu3S193	3	29	4

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	hu3S193
Total, other adverse events	hu3S193	28	29
Total, serious adverse events	hu3S193	3	29

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33664128	DERIVED

Source 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.

GET https://conductscience.org/api/trials/v1/NCT01137071

GET https://conductscience.org/api/trials/v1/NCT01137071/registered?page=2

API reference For AI assistants