A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Etoposide and Platinum Therapy (PINNACLE)
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ClinicalTrials.gov Identifier: NCT01859741 |
Recruitment Status :
Terminated
(OMP-59R5 did not improve PFS.)
First Posted : May 22, 2013
Results First Posted : May 1, 2019
Last Update Posted : September 9, 2020
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Condition or disease | Intervention/treatment | Phase |
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Stage IV Small Cell Lung Cancer | Drug: OMP-59R5 Drug: Etoposide Drug: Placebo Drug: Cisplatin or Carboplatin | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 172 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1b/2 Study of OMP-59R5 in Combination With Etoposide and Platinum Therapy in Subjects With Untreated Extensive Stage Small Cell Lung Cancer (PINNACLE) |
Actual Study Start Date : | January 7, 2012 |
Actual Primary Completion Date : | April 18, 2017 |
Actual Study Completion Date : | May 8, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: OMP-59R5 Combination with Etoposide and Cisplatin |
Drug: OMP-59R5
OMP-59R5 administered intravenously
Other Name: Tarextumab Drug: Etoposide administered intravenously Drug: Placebo administered IV Drug: Cisplatin or Carboplatin administered intravenously |
Experimental: Etoposide and Cisplatin plus Placebo |
Drug: OMP-59R5
OMP-59R5 administered intravenously
Other Name: Tarextumab Drug: Etoposide administered intravenously Drug: Placebo administered IV Drug: Cisplatin or Carboplatin administered intravenously |
- Phase 1b: To Determine the Maximum Tolerated Dose (MTD) of OMP-59R5 When Administered With Etoposide and Cisplatin or Carboplatin (Number of Subjects With DLTs) [ Time Frame: Up to 1 year in absence of unacceptable toxicity or disease progression. ]To determine the MTD of tarextumab when administered on Day 1 of each 21 day cycle along with etoposide 100 mg/m2 on Days 1, 2 and 3, and cisplatin 80 mg/m2 or carboplatin area under the curve (AUC) of 5 mg/mL•min on Day 1 in subjects with untreated extensive stage small cell lung cancer. DLT evaluable population includes all subjects who received at least 1 partial dose of OMP-59R5 during the Phase 1b dose escalation portion of the study including the carboplatin cohort and who had completed Day 21 cycle of 1 OMP-59R5 administration or had discontinued due to drug-related toxicity.
- Phase 1b: Overall Response (Response Evaluable Population) [ Time Frame: Up to 1 year in absence of unacceptable toxicity or disease progression. ]The best overall response is defined as the best Investigator-assessed response recorded from the start of the treatment until disease progression in the following order of importance: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Evaluable (NE). Response evaluable population includes subjects who received 1 partial dose of OMP-59R5 and at at least 1 post tumor assessment.
- Phase 2: Progression Free Survival (ITT Population) [ Time Frame: Up to 1 year until disease progression or death. ]To determine the improvement in Progression Free Survival (PFS) resulting from the addition of tarextumab to etoposide and platinum therapy (EP) in subjects receiving first-line therapy for extensive stage small cell lung cancer. PFS is based on the Investigator-assessments of tumor response which is defined as the number of days from randomization until death or disease progression as defined by RECIST criteria for the ITT Population.
- Phase 2: Best Overall Tumor Response Based on Investigator Assessment (ITT Population) [ Time Frame: Up to 1 year in absence of unacceptable toxicity or disease progression ]The response rate is the number of subjects per treatment arm who have either a complete response (CR) or partial response (PR) for best overall response (according to RECIST criteria) divided by the number of subjects randomized to the respective arms.

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must meet all of the following criteria to be eligible for the study:
- Histologically or cytologically documented extensive stage small cell lung cancer.
- Adults of 18 years of age or older.
- Performance Status (ECOG) of 0 or 1.
- Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.
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Adequate organ function:
- Adequate hematologic function (absolute neutrophil count [ANC] ≥ 1,500 cells/μL; hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/μL).
- Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min using Cockcroft-Gault formula).
- Adequate hepatic function (alanine aminotransferase [ALT] ≤ 3 x upper limit of normal [ULN], ALT may be ≤ 5 x ULN if due to liver metastases but cannot be associated with concurrent elevated bilirubin >1.5 times the upper limit of normal (ULN) unless it is approved by the Sponsor's Medical Monitor).
- Prothrombin Time (PT)/International Normalized Ration (INR) ≤1.5 × ULN, activated partial thromboplastin time (aPTT) ≤1.5 × ULN.
- Written consent on an Institutional Review Board (IRB)/IndependentEthics Committee (IEC)-approved Informed Consent Form prior to any study-specific evaluation.
- For women of child-bearing potential, negative serum pregnancy test at screening and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration or the last EP in the study, whichever is discontinued last.
- Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration or the last EP in the study, whichever is discontinued last.
Exclusion Criteria:
Subjects who meet any of the following criteria will not be eligible for participation in the study:
- Limited stage small cell lung cancer appropriate for radical treatment with chemoradiation.
- Prior therapy including radiation, chemotherapy or surgery for newly diagnosed extensive stage small cell lung cancer.
- Presence of any serious or uncontrolled illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure unstable angina pectoris, uncontrolled cardiac arrhythmia, uncontrolled arterial thrombosis, symptomatic pulmonary embolism, and psychiatric illness that would limit compliance with study requirement.
- History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or stenting within 6 months prior to the first administration of study drug.
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A history of malignancy with the exception of:
- Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer
- Adequately treated stage I cancer from which the subject is currently in remission, or
- Any other cancer from which the subject has been disease-free for ≥ 3 years
- Known human immunodeficiency virus (HIV) infection.
- Females who are pregnant or breastfeeding.
- Concurrent use of therapeutic warfarin (prophylactic low dose of warfarin, i.e., 1 mg daily for port catheter is allowed)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859741

Documents provided by Mereo BioPharma ( OncoMed Pharmaceuticals, Inc. ):
Responsible Party: | OncoMed Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT01859741 |
Other Study ID Numbers: |
59R5-003 |
First Posted: | May 22, 2013 Key Record Dates |
Results First Posted: | May 1, 2019 |
Last Update Posted: | September 9, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Newly diagnosed Stage IV Small Cell Lung Cancer |
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Cisplatin Carboplatin Etoposide Antineoplastic Agents Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |