A Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/20/2018 |
| Start Date: | May 2015 |
| End Date: | August 2018 |
A Randomized, Double-blind, Placebo-controlled Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine Versus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer
The purpose of this study is to determine whether the combination of MM-141 plus
nab-paclitaxel and gemcitabine is more effective than nab-paclitaxel and gemcitabine alone
based on Progression Free Survival (PFS) in front-line metastatic pancreatic cancer patients
with high serum levels of free IGF-1.
nab-paclitaxel and gemcitabine is more effective than nab-paclitaxel and gemcitabine alone
based on Progression Free Survival (PFS) in front-line metastatic pancreatic cancer patients
with high serum levels of free IGF-1.
This is a randomized, double-blind, placebo-controlled Phase 2 study of MM-141 plus
nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine in front-line
metastatic pancreatic cancer. All patients will be initially screened for free IGF-1 status.
Eligible patients with high free IGF-1 will be randomized to receive MM-141 plus
nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine and patients.
Patients with low free IGF-1 or patients who have high free IGF-1 but are not otherwise
eligible will be followed in an observational group.
nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine in front-line
metastatic pancreatic cancer. All patients will be initially screened for free IGF-1 status.
Eligible patients with high free IGF-1 will be randomized to receive MM-141 plus
nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine and patients.
Patients with low free IGF-1 or patients who have high free IGF-1 but are not otherwise
eligible will be followed in an observational group.
Inclusion Criteria:
- Metastatic adenocarcinoma of the pancreas. Patients with islet cell neoplasms are not
eligible.
- Patient must have received no prior radiotherapy, surgery, chemotherapy, or
investigational therapy for the treatment of metastatic disease.
- Blood sample sent for free IGF-1 testing
- ECOG performance status (PS) of 0 or 1
Exclusion Criteria:
- Patients who only present with localized disease
- Patients with CNS malignancies (primary or metastatic)
- Clinically significant cardiac disease
We found this trial at
48
sites
Buffalo, New York 14263
Principal Investigator: Wen Wee Ma, MD
Phone: 716-845-8309
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2220 Pierce Ave
Nashville, Tennessee 37232
Nashville, Tennessee 37232
615-936-8422
Principal Investigator: Emily Chan, MD
Phone: 615-875-0060
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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116th St and Broadway
New York, New York 10027
New York, New York 10027
(212) 854-1754
Principal Investigator: Paul Oberstein, MD
Phone: 212-342-0248
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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Bethlehem, Pennsylvania
Principal Investigator: Asim Ali, MD
Phone: 484-526-3589
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303 East Superior Street
Chicago, Illinois 60611
Chicago, Illinois 60611
Principal Investigator: Halla Nimeiri, MD
Phone: 312-695-1102
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2035 W Taylor St
Chicago, Illinois
Chicago, Illinois
(312) 996-4350
Principal Investigator: Arkadiusz Dudek, MD
Phone: 312-413-1902
University of Illinois at Chicago A major research university in the heart of one of...
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East Setauket, New York 11733
Principal Investigator: David Chu, MD
Phone: 631-675-5143
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Fullerton, California 92835
Principal Investigator: David Park, MD
Phone: 714-446-5364
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Gilbert, Arizona 85234
Principal Investigator: Madappa N. Kundranda, MD
Phone: 480-256-4649
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Lafayette, Louisiana 70503
Principal Investigator: Salman Malad, MD
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Los Angeles, California
Principal Investigator: Randolph Hecht, MD
Phone: 310-633-8400
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Newnan, Georgia 30265
Principal Investigator: Eyal Meiri, MD
Phone: 770-400-7191
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Park Ridge, Illinois 60068
Principal Investigator: Edward James, MD
Phone: 847-410-0667
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Pembroke Pines, Florida 33028
Principal Investigator: Pablo Ferraro, MD
Phone: 954-265-1864
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Philadelphia, Pennsylvania 19111
Principal Investigator: Crystal Denlinger, MD
Phone: 215-214-1685
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Redondo Beach, California 90277
Principal Investigator: Hugo Hool, MD
Phone: 310-750-3376
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San Francisco, California 94115
Principal Investigator: Andrew Ko, MD
Phone: 415-353-7284
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Santa Barbara, California 93105
Principal Investigator: Gregg Newman, MD
Phone: 805-898-3602
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Santa Maria, California 93454
Principal Investigator: Robert Dichmann, MD
Phone: 805-346-3461
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Spokane Valley, Washington 99216
Principal Investigator: Danko Martincic, MD
Phone: 509-228-1188
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Tulsa Cancer Institute, Pllc Now under the new name of Tulsa Cancer Institute, our specialists...
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Worcester, Massachusetts 01608
Principal Investigator: James Rooney, MD
Phone: 508-556-5431
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