Trial Outcomes & Findings for A6 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer (NCT NCT00939809)

Last Updated: 2019-01-15

Results Overview

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

Scans to assess progression were done every other cycle for the first 6 months.

Results posted on

2019-01-15

Participant Flow

The study was activated on 7/6/2009 and closed to accrual on 1/4/2010.

Participant milestones

Participant milestones
Measure	A6 (Subcutaneous) 300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Study STARTED	31
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	A6 (Subcutaneous) 300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Study Adverse Event	2
Overall Study Death	1

Baseline Characteristics

A6 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A6 (Subcutaneous) n=31 Participants 300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Age, Customized 40-49 years	1 participants n=5 Participants
Age, Customized 50-59 years	11 participants n=5 Participants
Age, Customized 60-69 years	17 participants n=5 Participants
Age, Customized 70-79 years	2 participants n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Scans to assess progression were done every other cycle for the first 6 months.

Population: Eligible and treated participants

Outcome measures

Outcome measures
Measure	A6 (Subcutaneous) n=31 Participants 300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Progression-free Survival at 6 Months	6.5 percentage of participants Interval 1.2 to 18.9

PRIMARY outcome

Timeframe: Scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.

Population: Eligible and treated participants

Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRI or CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.

Outcome measures

Outcome measures
Measure	A6 (Subcutaneous) n=31 Participants 300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Tumor Response	0 percentage of participants Interval 0.0 to 9.2

PRIMARY outcome

Timeframe: Every cycle during treatment (average collection time = 4 months)

Population: Eligible and Treated Patients

Outcome measures

Outcome measures
Measure	A6 (Subcutaneous) n=31 Participants 300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 Constitutional	2 Participants
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 Gastrointestinal	1 Participants
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 Hemorrhage	1 Participants

SECONDARY outcome

Timeframe: scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.

Population: Eligible and treated participants

Outcome measures

Outcome measures
Measure	A6 (Subcutaneous) n=31 Participants 300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Progression-free Survival	2.0 months Interval 1.8 to 3.0

SECONDARY outcome

Timeframe: Every other cycle, up to 5 years

Population: Eligible and treated participants

Outcome measures

Outcome measures
Measure	A6 (Subcutaneous) n=31 Participants 300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Overall Survival	10.6 months Interval 8.4 to NA (not applicable): insufficient number of participants with events.

SECONDARY outcome

Timeframe: Day 1 prior to dosing; Day 2 prior to dosing and 4-hour post dosing; Day 8 prior to dosing.

Population: due to the limited activity of this agent, it was decided not to expend resources assaying the PBMCs.

Note: due to the limited activity of this agent, it was decided not to expend resources assaying the PBMCs. Data was not collected.

Outcome measures

Outcome data not reported

Adverse Events

A6 (Subcutaneous)

Serious events: 9 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	A6 (Subcutaneous) n=31 participants at risk 300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
General disorders Death No Ctcae Term - Sudden Death	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Distention	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Anorexia	6.5% 2/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Vascular disorders Hemorrhage, Cns	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Hepatobiliary disorders Cholecystitis	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Nerve-Peripheral	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Pain: Back	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary: Other	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.

Other adverse events

Other adverse events
Measure	A6 (Subcutaneous) n=31 participants at risk 300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
Ear and labyrinth disorders Hearing (Without Monitoring Program)	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Ear and labyrinth disorders Tinnitus	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Blood and lymphatic system disorders Neutrophils	16.1% 5/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Blood and lymphatic system disorders Platelets	16.1% 5/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Blood and lymphatic system disorders Leukocytes	16.1% 5/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Blood and lymphatic system disorders Lymphopenia	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Blood and lymphatic system disorders Hemoglobin	54.8% 17/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Cardiac disorders Hypertension	12.9% 4/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Sweating	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Weight Gain	6.5% 2/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Fever	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Fatigue	45.2% 14/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Insomnia	6.5% 2/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Skin and subcutaneous tissue disorders Nail Changes	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Skin and subcutaneous tissue disorders Injection Site Reaction	9.7% 3/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Skin and subcutaneous tissue disorders Hair Loss/Alopecia (Scalp Or Body)	6.5% 2/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Skin and subcutaneous tissue disorders Bruising	9.7% 3/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Skin and subcutaneous tissue disorders Rash	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Skin and subcutaneous tissue disorders Dry Skin	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Endocrine disorders Hot Flashes	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Flatulence	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Heartburn	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Dysphagia	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Distention	9.7% 3/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Vomiting	12.9% 4/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Anorexia	16.1% 5/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Constipation	22.6% 7/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Nausea	29.0% 9/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Gastrointestinal disorders Diarrhea	6.5% 2/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Vascular disorders Hemorrhage, Gu - Vagina	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Vascular disorders Hemorrhage, Gi - Rectum	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Vascular disorders Hematoma	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Blood and lymphatic system disorders Edema: Trunk/Genital	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Blood and lymphatic system disorders Edema: Limb	6.5% 2/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Ast	6.5% 2/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Gfr	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Metabolic/Laboratory - Other	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Creatinine	6.5% 2/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Hypoalbuminemia	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Alt	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Alkaline Phosphatase	6.5% 2/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Bilirubin	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Lipase	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Hyponatremia	9.7% 3/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Hyperuricemia	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Amylase	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Hypocalcemia	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Hyperglycemia	9.7% 3/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Hypokalemia	6.5% 2/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Metabolism and nutrition disorders Hypomagnesemia	6.5% 2/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Nervous system disorders Mood Alteration - Depression	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Nervous system disorders Mood Alteration - Anxiety	6.5% 2/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Nervous system disorders Tremor	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Nervous system disorders Confusion	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Nervous system disorders Dizziness	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Nervous system disorders Neuropathy-Sensory	19.4% 6/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Eye disorders Flashing Lights/Floaters	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Pain - Other	6.5% 2/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Pain: Pelvis	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Pain: Head/Headache	9.7% 3/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Pain: Extremity-Limb	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Pain: Back	19.4% 6/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Pain: Joint	12.9% 4/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Pain: Bladder	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Pain: Abdominal Pain Nos	41.9% 13/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Pain: Skin	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
General disorders Pain: Muscle	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Respiratory, thoracic and mediastinal disorders Cough	6.5% 2/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	9.7% 3/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Renal and urinary disorders Leak, Gu - Urethra	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Renal and urinary disorders Urinary Retention	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Renal and urinary disorders Bladder Spasm	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Renal and urinary disorders Urinary Frequency	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.
Vascular disorders Thrombosis/Thrombus/Embolism	3.2% 1/31 • Adverse events were queried for and collected every cycle for the duration of treatment.

Additional Information

Jessalyn Reboy

Gynecologic Oncology Group Statistical and Data Center

Phone: 716-845-7738

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place