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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-27

Study Completion Date

2010-07-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colon Cancer Colorectal Cancer Gastrointestinal Cancer Metastatic Colorectal Cancer Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Part 1: Panitumumab + Rilotumumab

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.

Group Type EXPERIMENTAL

Panitumumab

Intervention Type DRUG

Panitumumab for intravenous infusion

Rilotumumab

Intervention Type DRUG

Rilotumumab for intravenous infusion

Part 2: Panitumumab Alone

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

Group Type ACTIVE_COMPARATOR

Panitumumab

Intervention Type DRUG

Panitumumab for intravenous infusion

Part 2: Panitumumab + Rilotumumab

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.

Group Type EXPERIMENTAL

Panitumumab

Intervention Type DRUG

Panitumumab for intravenous infusion

Rilotumumab

Intervention Type DRUG

Rilotumumab for intravenous infusion

Placebo

Intervention Type DRUG

Placebo intravenous infusion

Part 2: Panitumumab + Ganitumab

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.

Group Type EXPERIMENTAL

Panitumumab

Intervention Type DRUG

Panitumumab for intravenous infusion

Ganitumab

Intervention Type DRUG

Ganitumab for intravenous infusion

Placebo

Intervention Type DRUG

Placebo intravenous infusion

Part 3: Rilotumumab

Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.

Group Type EXPERIMENTAL

Rilotumumab

Intervention Type DRUG

Rilotumumab for intravenous infusion

Placebo

Intervention Type DRUG

Placebo intravenous infusion

Part 3: Ganitumab

Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.

Group Type EXPERIMENTAL

Ganitumab

Intervention Type DRUG

Ganitumab for intravenous infusion

Placebo

Intervention Type DRUG

Placebo intravenous infusion

Interventions

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Panitumumab

Panitumumab for intravenous infusion

Intervention Type DRUG

Ganitumab

Ganitumab for intravenous infusion

Intervention Type DRUG

Rilotumumab

Rilotumumab for intravenous infusion

Intervention Type DRUG

Placebo

Placebo intravenous infusion

Intervention Type DRUG

Other Intervention Names

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Vectibix® AMG 479 AMG 102

Eligibility Criteria

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Inclusion Criteria

* metastatic adenocarcinoma of the colon or rectum
* wild-type KRAS tumor status
* radiographic evidence of disease progression during or following treatment with irinotecan and/or oxaliplatin containing chemotherapy for mCRC
* measurable disease \>/= 20 mm per Response Evaluation Criteria In Solid Tumors (RECIST)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* adequate laboratory values

Exclusion Criteria

* history of central nervous system (CNS) metastases
* history of another primary cancer, unless:
* curatively resected non-melanomatous skin cancer
* curatively treated cervical carcinoma in situ
* other primary solid tumor treated with curative intent and no known active disease present for \>/= 5 years
* prior treatment with an anti-epithelial growth factor receptor (EGFR), hepatocyte growth factor receptor (HGFR, c-MET), and/or insulin-like growth factor receptor (IGFR) inhibitor
* prior treatment with AMG 102 or AMG 479
* prior treatment with chemotherapy or radiotherapy \</= 21 days
* prior treatment with targeted therapy \</= 30 days
* known allergy or hypersensitivity to panitumumab, AMG 102, or AMG 479
* history of interstitial lung disease
* clinically significant cardiovascular disease \</= 1 year
* active inflammatory bowel disease
* known human immunodeficiency virus (HIV), hepatitis C, or hepatitis B infection
* any co-morbid disease or condition that could increase the risk of toxicity
* serious or non-healing wound \</= 35 days
* any uncontrolled concurrent illness or history of any medical condition that could interfere with the interpretation of the study results
* major surgical procedure \</= 35 days or minor surgical procedure \</= 14 days
* other investigational procedures or drugs \</= 30 days

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No