Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioma

Glioblastoma

Gliosarcoma

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Rilotumumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.

AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.

AMG 102

Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102.

Avastin

Katherine B Peters, MD, PhD

Mary Lou Affronti, DNP ANP MHSc

The primary purpose of the study is to assess the response rate of AMG 102 and Avastin treatment in subjects with advanced malignant glioma. Secondary objectives are to estimate overall survival and 6-month progression-free survival rates in this population and to assess the safety of this combination in this population.

Patients must have recurrent histologically confirmed diagnosis of World Health Organization (WHO) grade IV malignant glioma (glioblastoma multiforme or gliosarcoma) with no more than 3 prior progressions. Subjects will receive Avastin and AMG 102 every two weeks. Avastin will be administered prior to AMG 102. Up to 36 adult subjects will take part in this study at Duke.

In initial Phase I and II clinical trials, four potential Avastin-associated safety issues were identified: hypertension, proteinuria, thromboembolic events, and hemorrhage. The most common side effect for AMG 102 have been nausea and fatigue.

AMG 102 and Avastin for Recurrent Malignant Glioma

Phase II Study to Evaluate the Efficacy and Safety of AMG 102 and Avastin in Subjects With Recurrent Malignant Glioma

The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria will be determined. Complete Response (CR) is defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) is defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Tumor assessments are done at baseline and the end of every 6-week cycle thereafter.

Overall survival is defined as the time in months from the start of protocol treatment until the date of death, or the date of last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.

The percentage of participants alive and progression-free at 6 months after the start of study treatment will be determined. PFS6 will be calculated from the date study treatment started until the date of progression or death, or the date of last follow-up if participants are alive without progression. Kaplan-Meier methods will be used to estimate survival.

The percentage of participants who experience unacceptable toxicity, defined as any treatment-related grade 2 or greater CNS hemorrhage or grade 4 or greater non-hematologic toxicity, will be calculated.

Amgen

Katy Peters

Assistant Professor of Medicine

Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.

Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.

AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.

Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102.

AMG 102 With Avastin

Age, Continuous

Sex: Female, Male

11/21/14 Amgen notified PI they stopped their own AMG102 studies due to increased risk found in the TX arm on a different study. Dr. Peters decided to stop TX on the 3 current subjects on her study at that time although no increased risks were found.

Katherine B. Peters, MD, PhD

Radiographic Response

Median Overall Survival (OS)

Six-month Progression-free Survival (PFS6)

Percentage of Participants Who Experience Treatment-related Grade 2 or Greater CNS Hemorrhage or Grade 4 or Greater Non-hematologic Toxicities

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Heart and Blood Diseases

Small Cell Lung Carcinoma

Pleural Effusion

Lung Neoplasms

Pleural Effusion, Malignant

Lymphadenopathy

Pericardial Effusion

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Carboplatin

Etoposide

Cisplatin

Etoposide phosphate

Enzyme Inhibitors

Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide

Blinded placebo and carboplatin or cisplatin and etoposide

Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide

AMG 479

Placebo is administered with Carboplatin and Etoposide

Placebo

Carboplatin is administered to some subjects in combination

Cisplatin is administered to some subjects in combination

This trial is titled "A Phase 1b/2 trial of AMG 479 or AMG 102 with Platinum-Based Chemotherapy as First-Line Treatment for Extensive Stage Small-Cell Lung Cancer (SCLC)."

Part 1, the phase 1b portion of this study, is a multicenter, open-label investigation to identify safe dose levels of either AMG 102 or AMG 479 in combination with etoposide plus cisplatin or carboplatin in subjects with previously untreated extensive stage SCLC.

Part 2, the phase 2 portion of this study, is a multicenter, double-blind, 3-arm investigation to evaluate overall survival of either AMG 102 or AMG 479 in combination with platinum-based chemotherapy.

QUILT-2.013: A Trial of AMG 479 or AMG 102 in Combination With Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer

Amgen Protocol 20060534 - A Phase 1b/2 Trial of AMG 479 or AMG 102 in Combination With Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer

NantCell, Inc.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Analgesics

Anti-Inflammatory Agents

Mitoxantrone

Prednisone

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Immunologic Factors

Phase 1b is an open-label study with AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed, will be administered by IV Q3W in combination with MP.

AMG 102 safe dose level in phase 1b in combination with MP, will be administered by IV Q3W.

Placebo in combination with MP, will be administered by IV Q3W.

Safe dose level in phase 1b of AMG 102 + MP will be administered by Q3W

Investigational product to be given at safe dose from phase 1b, will be administered by IV Q3W.

Investigational product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment, will be administered by IV Q3W.

Administered Q3W for a maximum of 12 cyles

The primary objectives of this study are the following:

Phase 1b: To identify a safe dose level of AMG 102, up to 15 mg/kg Q3W, to combine with mitoxantrone and prednisone (MP) Phase 2: To estimate with adequate precision the effect of the addition of AMG 102 to MP, compared with placebo plus MP, as assessed by the hazard ratio (HR) for overall survival (OS) of previously treated subjects with castrate-resistant prostate cancer (CRPC)

AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer

A Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer

Infections

Digestive System Diseases

Sarcoma

Virus Diseases

Colorectal Neoplasms

Rectal Neoplasms

Colonic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Intestinal Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Soft Tissue Sarcoma

Herbal and Botanical

Panitumumab

Cola

Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.

Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.

Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.

Ganitumab

This study is a global, multicenter, open-label phase 1b and randomized, double-blinded, 2 part, phase 2 study designed to evaluate the safety and efficacy of rilotumumab or ganitumab in combination with panitumumab versus panitumumab alone in patients with metastatic colorectal cancer whose tumors are wild-type KRAS status.

This study consisted of 3 parts:

Part 1: determination of the tolerable dose of rilotumumab in combination with panitumumab to be administered in Part 2.

Part 2: Comparison of the safety and efficacy of rilotumumab or ganitumab in combination with panitumumab versus that of panitumumab alone. In Part 2, participants were randomized 1:1:1 into 3 cohorts: 6 mg/kg panitumumab plus 10 mg/kg rilotumumab, 6 mg/kg panitumumab plus 12 mg/kg ganitumab, or 6 mg/kg panitumumab and placebo (panitumumab alone cohort). Panitumumab was administered open-label, and rilotumumab and ganitumab were double-blinded.

Part 3: Exploratory evaluation of the safety and efficacy of the rilotumumab and ganitumab monotherapy following treatment with panitumumab in Part 2. In Part 3, eligible participants who terminated panitumumab treatment in the Panitumumab Alone arm of Part 2 due to disease progression or intolerability could be randomized 1:1 into 2 double-blind cohorts: 10 mg/kg rilotumumab or 12 mg/kg ganitumab.

Participants who permanently discontinued all the investigational products completed a safety follow-up visit 30 days and a follow-up visit 60 days after the last dose of investigational product. Participants were followed for radiographic disease progression and survival every 3 months after the 30-day safety follow-up visit for up to 2 years after the last participant was enrolled in Part 2.

Panitumumab Combination Study With Rilotumumab or Ganitumab in Wild-type Kirsten Rat Sarcoma Virus Oncogene Homolog (KRAS) Metastatic Colorectal Cancer (mCRC)

A Randomized, Phase 1b/2 Trial of AMG 102 or AMG 479 in Combination With Panitumumab Versus Panitumumab Alone in Subject With Wild-Type KRAS Metastatic Colorectal Cancer

A DLT is defined as any grade 3 or 4 rilotumumab-related or combination (panitumumab and rilotumumab)-related adverse event or laboratory abnormality that is deemed clinically significant by the investigator

An objective response is defined as a confirmed complete (CR) or partial response (PR) no less than 4 weeks after the criteria for response are first met, determined by the investigator considering the radiologic response of all existing target and non-target lesions, evidence of new lesions, and cytology evaluation (as appropriate) according to the Modified-Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 criteria: CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders. Tumor assessments up to the initiation of another anti-tumor therapy including the Part 3 treatment, if applicable, were used.

The interval from the first visit of a confirmed objective response to disease progression as defined by the modified RECIST v1.0 criteria. Participants who did not progress by the earlier of the analysis data cutoff date, initiating a new line of anti-tumor therapy, and the start of Part 3 dosing where applicable were censored at their last evaluable disease assessment date prior to the end of reporting period. Progressive disease is defined as at least a 20% increase in the size of target lesions, or unequivocal progression of existing non-target lesions, or any new lesions.

The interval from the first dose of study therapy to the date of the first confirmed objective response, calculated only for participants with an objective response.

The percentage of participants with an overall objective response of CR, PR, or stable disease (SD). CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD). SD: Neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for PD and no progression of non-target lesions, or the persistence of one or more non-target lesion(s) not qualifying for either CR or PD.

The interval from the first dose of study therapy to the earlier date of disease progression (per modified-RECIST v1.0) or death. Participants who did not progress or die by the analysis data cutoff date were censored at their last evaluable disease assessment date prior to the earlier of the analysis data cutoff date, initiating a new line of anti-tumor therapy, and receiving study treatment in Part 3 where applicable. Participants enrolled into Part 3 or who started a new line of anti-tumor therapy before radiographic progression but subsequently died were considered as having an event with the event date same as the death date.

An event is defined as a radiographic progression or death that occurred from the first dose to 28 days since the last dose of study therapy. Participants who did not progress or die during this period were censored at their last evaluable disease assessment before the end of the 28-day period. Participants who received Part 3 treatment before 28 days since their last dose of study drug in Part 2 and did not have radiographic progression or die were censored at their last evaluable disease assessment prior to receiving therapy in Part 3. Radiographic progressions after start of a new anti-tumor therapy, including Part 3 treatment, or after 28 days since the last dose in Part 2 were excluded from the analysis. Participants who died with no prior radiographic disease progression during Part 3 treatment, but within the 28-day period since the last dose in Part 2 were considered as having an event.

The interval from the first dose of study therapy to the date of death. Participants still alive at the analysis data cutoff date were censored at their last contact date.

A serious adverse event (SAE) is defined as an AE that is fatal, life threatening (places the participant at immediate risk of death), requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other significant medical hazard. AEs were graded for severity according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 3: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. AEs were assessed by the investigator for the relationship of the AE to each one or more of the investigational products by the question: "Is there a reasonable possibility that the event may have been caused by the investigational product?"

The severity of laboratory toxicities was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 3: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal.

Validated immunoassays were used to detect anti-panitumumab, anti-rilotumumab and anti-ganitumab binding antibodies.

Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Part 1: Panitumumab + Rilotumumab

Part 2: Panitumumab Alone

Part 2: Panitumumab + Rilotumumab

Part 2: Panitumumab + Ganitumab

Total

Part 1 Participants

Part 2 Participants

White or Caucasian

Black or African American

Hispanic or Latino

Asian

Other

Race/Ethnicity, Customized

Colon cancer

Rectal cancer

Primary Tumor Type

Well differentiated

Moderately differentiated

Poorly differentiated

Undifferentiated

Unknown

Adenocarcinoma Differential of Primary Tumor

Data available for 9, 46, 46, and 45 participants in each treatment group respectively

Months Since Primary Diagnosis

Months Since Metastatic Disease Diagnosis

Safety analysis set, including participants who received at least one dose of respective investigational product in the corresponding parts of the study.

Study Director

The first 6 DLT evaluable participants, including participants who received at least 2 doses of panitumumab and rilotumumab as scheduled (ie, Week 1 and 3) and have a minimum 28 days follow-up for safety or, have received at least 1 dose of panitumumab and rilotumumab and had a DLT within the first 28 days on study.

Part 1: Number of Participants With Dose-limiting Toxicities (DLT)

For the primary analysis of objective response rate (ORR) for Part 2, a Beta(6.3, 33.7) and Beta(1.1, 5.9) was used as priors for panitumumab alone and combination regimens in calculating the posterior distribution of the ORR for each respective treatment group. The posterior mean and 95% credible region are reported.

The posterior mean difference in ORR and the 95% credible region for the difference in the ORR between panitumumab + rilotumumab compared to panitumumab alone.

The posterior mean difference in ORR and the 95% credible region for the difference in the ORR between panitumumab + ganitumab compared to panitumumab alone.

The posterior distribution of the odds ratio for an ORR was used to assess whether rilotumumab and/or ganitumab in combination with panitumumab has a higher ORR compared to panitumumab alone. A 95% credible region was calculated for the odds ratio.

The posterior probability of the odds ratio being \> 1 is reported as the P-value.

The posterior distribution of the odds ratio for an ORR was used to assess whether rilotumumab and/or ganitumab in combination with panitumumab has a higher ORR compared to panitumumab alone. A 95% credible region was calculated for the odds ratio. The posterior probability of the odds ratio being \> 1 is reported as the P-value.

Efficacy analysis set (enrolled participants who received at least one dose of respective investigational product in the corresponding parts of the study) with measurable baseline disease.

Part 2: Percentage of Participants With an Objective Response

Efficacy analysis set; participants with an objective response of CR or PR.

Part 2: Duration of Response

Part 2: Time to Response

Part 2: Percentage of Participants With Disease Control

Progression-free Survival

On-treatment Progression-free Survival

Overall Survival

Any adverse event

Safety analysis set (all enrolled participants who received at least 1 dose of investigational product).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
AMG 102 and Avastin for Recurrent Malignant Glioma	NCT01113398	Glioblastoma Mu... Gliosarcoma	AMG 102 Avastin	18 Years -	Duke University
QUILT-2.013: A Trial of AMG 479 or AMG 102 in Combination With Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer	NCT00791154	Lung Cancer Small Cell Lung... Solid Tumors Extensive-stage...	AMG 479 Etoposide Placebo AMG 102 Carboplatin Cisplatin	18 Years -	NantCell, Inc.
AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer	NCT00770848	Cancer Castrate-Resist... Mestastatic Pro... Prostate Cancer	AMG 102 AMG 102 Mitoxantrone Placebo Prednisone	18 Years -	Amgen
Panitumumab Combination Study With Rilotumumab or Ganitumab in Wild-type Kirsten Rat Sarcoma Virus Oncogene Homolog (KRAS) Metastatic Colorectal Cancer (mCRC)	NCT00788957	Colon Cancer Colorectal Canc... Gastrointestina... Metastatic Colo... Rectal Cancer	Panitumumab Ganitumab Rilotumumab Placebo	18 Years -	Amgen

Spots Global Cancer Trial Database for amg 102

Every month we try and update this database with for amg 102 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for amg 102

Every month we try and update this database with for amg 102 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for amg 102 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.