Trial Outcomes & Findings for AMG 706 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer (NCT NCT00574951)

Last Updated: 2018-01-11

Results Overview

RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

CT scan or MRI every other cycle for the first 6 months; then every 3 months thereafter; and at any other time if clinically indicated up to 5 years.

Results posted on

2018-01-11

Participant Flow

The study was activated on 12/10/2007 and closed to accrual on 4/22/2008.

Participant milestones

Participant milestones
Measure	AMG 706 AMG 706 125 mg PO daily continuously (one cycle is 28 days) until disease progression or adverse effects prohibit further therapy
Overall Study STARTED	23
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	AMG 706 AMG 706 125 mg PO daily continuously (one cycle is 28 days) until disease progression or adverse effects prohibit further therapy
Overall Study Ineligible - improper prior treatment	1

Baseline Characteristics

AMG 706 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	AMG 706 n=22 Participants AMG 706 125 mg PO daily continuously (one cycle is 28 days) until disease progression or adverse effects prohibit further therapy
Age, Continuous	64.4 years STANDARD_DEVIATION 9.6 • n=99 Participants
Age, Customized Age at study entry · 50-59 years	7 Participants n=99 Participants
Age, Customized Age at study entry · 60-69 years	9 Participants n=99 Participants
Age, Customized Age at study entry · 70-79 years	5 Participants n=99 Participants
Age, Customized Age at study entry · 80-89 years	1 Participants n=99 Participants
Sex: Female, Male Female	22 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: CT scan or MRI every other cycle for the first 6 months; then every 3 months thereafter; and at any other time if clinically indicated up to 5 years.

Population: Eligible and treated patients.

Outcome measures

Outcome measures
Measure	AMG 706 n=22 Participants AMG 706 125 mg PO daily continuously (one cycle is 28 days) until disease progression or adverse effects prohibit further therapy
Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 Partial response	1 Participants
Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 Complete response	0 Participants

PRIMARY outcome

Timeframe: CT scan or MRI every other cycle for the first 6 months

Population: Time of progression could not be validly collected due to the study being prematurely closed due to severe neurological adverse events, thus 6-month PFS cannot be presented. For safety reasons, most patients (16/22) were taken off study drug prior to progression (or AE), and follow-up for progression after coming off study was not collected.

Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. In this study, time of progression could not be validly collected due to the study being prematurely closed secondary to severe neurological adverse events seen in 4 patients,

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.

Population: Eligible and treated patients.

Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

Outcome measures

Outcome measures
Measure	AMG 706 n=22 Participants AMG 706 125 mg PO daily continuously (one cycle is 28 days) until disease progression or adverse effects prohibit further therapy
Duration of Overall Survival (OS)	13.1 months Interval 8.1 to Not available because data was not sufficiently mature at the time of analysis to calculate the estimate. Won't become available because study was terminated for toxicity

SECONDARY outcome

Timeframe: Assessed every cycle while on treatment, 30 days after the last cycle of treatment

Population: Eligible and treated patients

Number of participants with a maximum grade of 3 or higher during the treatment period.

Outcome measures

Outcome measures
Measure	AMG 706 n=22 Participants AMG 706 125 mg PO daily continuously (one cycle is 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 Cardiac	2 Participants
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 Gastrointestinal	5 Participants
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 Hepatobiliary	1 Participants
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 Metabolic	4 Participants
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 Muskuloskeletal	1 Participants
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 Other Neurological	4 Participants
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 Pain	1 Participants
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 Pulmonary	1 Participants
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 Death, Not CTC coded	1 Participants

SECONDARY outcome

Timeframe: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months thereafter; and at any other time if clinically indicated, up to 5 years

Population: Study Analysis aborted due to severe toxicities. Estimates not calculated. Follow up for progression after coming off study was not collected in a manner that yields time to time to progression data.

Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. In this study time of progression could not be validly collected due to the study being prematurely closed, secondary to severe neurological adverse events seen in 4 patients, and thus progression-free survival (PFS) cannot be presented. For safety reasons, most patients (16/22) were taken off study drug prior to progression (or AE),

Outcome measures

Outcome data not reported

Adverse Events

AMG 706

Serious events: 11 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AMG 706 n=22 participants at risk AMG 706 125 mg PO daily continuously (one cycle is 28 days) until disease progression or adverse effects prohibit further therapy
Cardiac disorders Hypertension	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
General disorders Death No Ctcae Term - Disease Progression Nos	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Gastrointestinal disorders Obstruction, Gi - Small Bowel Nos	9.1% 2/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Gastrointestinal disorders Vomiting	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Hepatobiliary disorders Cholecystitis	9.1% 2/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Metabolism and nutrition disorders Creatinine	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Musculoskeletal and connective tissue disorders Fracture	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Nervous system disorders Neurology - Other	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Nervous system disorders Seizure	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Nervous system disorders Confusion	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up

Other adverse events

Other adverse events
Measure	AMG 706 n=22 participants at risk AMG 706 125 mg PO daily continuously (one cycle is 28 days) until disease progression or adverse effects prohibit further therapy
Ear and labyrinth disorders Auditory/Ear - Other	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Ear and labyrinth disorders Tinnitus	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Blood and lymphatic system disorders Neutrophils	9.1% 2/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Blood and lymphatic system disorders Platelets	9.1% 2/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Blood and lymphatic system disorders Leukocytes	31.8% 7/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Blood and lymphatic system disorders Hemoglobin	50.0% 11/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Cardiac disorders Palpitations	9.1% 2/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Cardiac disorders Hypertension	40.9% 9/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
General disorders Weight Loss	9.1% 2/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
General disorders Fatigue	68.2% 15/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Skin and subcutaneous tissue disorders Rash	9.1% 2/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Skin and subcutaneous tissue disorders Dry Skin	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Endocrine disorders Hot Flashes	9.1% 2/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Endocrine disorders Hypothyroidism	13.6% 3/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Gastrointestinal disorders Heartburn	9.1% 2/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Gastrointestinal disorders Mucositis (Functional/Sympt) - Oral Cavity	9.1% 2/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Gastrointestinal disorders Vomiting	18.2% 4/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Gastrointestinal disorders Anorexia	27.3% 6/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Gastrointestinal disorders Dehydration	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Gastrointestinal disorders Constipation	13.6% 3/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Gastrointestinal disorders Nausea	50.0% 11/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Gastrointestinal disorders Diarrhea	40.9% 9/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Vascular disorders Hemorrhage/Pulmonary - Nose	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Hepatobiliary disorders Cholecystitis	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	9.1% 2/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Infections and infestations Colitis, Infectious (Eg.C. Difficile)	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Bladder	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Metabolism and nutrition disorders Ast	31.8% 7/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Metabolism and nutrition disorders Creatinine	22.7% 5/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Metabolism and nutrition disorders Hypoalbuminemia	13.6% 3/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Metabolism and nutrition disorders Alt	22.7% 5/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Metabolism and nutrition disorders Alkaline Phosphatase	22.7% 5/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Metabolism and nutrition disorders Hypophosphatemia	9.1% 2/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Metabolism and nutrition disorders Hyponatremia	13.6% 3/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Metabolism and nutrition disorders Hypernatremia	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Metabolism and nutrition disorders Hypocalcemia	22.7% 5/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Metabolism and nutrition disorders Hyperglycemia	27.3% 6/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Metabolism and nutrition disorders Hypokalemia	22.7% 5/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Metabolism and nutrition disorders Hypomagnesemia	9.1% 2/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Musculoskeletal and connective tissue disorders Muscle Weakness - Whole Body/Generalized	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Nervous system disorders Neurology - Other	9.1% 2/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Nervous system disorders Mood Alteration - Depression	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Nervous system disorders Seizure	9.1% 2/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Nervous system disorders Cns Ischemia	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Nervous system disorders Confusion	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Nervous system disorders Dizziness	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Nervous system disorders Neuropathy-Sensory	27.3% 6/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Nervous system disorders Neuropathy-Motor	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Eye disorders Flashing Lights/Floaters	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
General disorders Pain: Chest /Thorax Nos	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
General disorders Pain: Head/Headache	59.1% 13/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
General disorders Pain: Extremity-Limb	18.2% 4/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
General disorders Pain: Back	18.2% 4/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
General disorders Pain: Joint	9.1% 2/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
General disorders Pain: Bone	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
General disorders Pain: Stomach	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
General disorders Pain: Abdominal Pain Nos	18.2% 4/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
General disorders Pain: Skin	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Respiratory, thoracic and mediastinal disorders Cough	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Respiratory, thoracic and mediastinal disorders Pleural Effusion	4.5% 1/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Respiratory, thoracic and mediastinal disorders Dyspnea	18.2% 4/22 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up

Additional Information

Angela Kuras on behalf of Mike Sill, PhD

NRG Oncology

Phone: 716-845-5702

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60