NOLAN: Naproxen or Loratadine and Neulasta
This study is currently recruiting participants.
Verified May 2013 by Amgen
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01712009
First received: October 19, 2012
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
In this study, the investigational products are naproxen, a non-steroidal antiinflammatory drug (NSAID), and loratadine, an anti-histamine. Both agents are being investigated as prophylactic medications to reduce the incidence and/or severity of bone pain in breast cancer subjects receiving adjuvant or neoadjuvant myelosuppressive chemotherapy and pegfilgrastim prophylaxis.
| Condition | Intervention | Phase |
|---|---|---|
|
Bone Pain in Stage I - III Breast Cancer |
Drug: Naproxen Drug: Loratadine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized, Phase 2 Study to Estimate the Effect of Prophylactic Intervention With Naproxen or Loratadine on Bone Pain in Breast Cancer Subjects Receiving Chemotherapy and Pegfilgrastim |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Bone pain (all grade) in cycle 1 [ Time Frame: Will be assessed 30 days after all subjects complete chemotherapy ] [ Designated as safety issue: No ]To estimate the difference in cycle 1 bone pain (all grade) between treatment groups (naproxen, loratadine, or no therapy) captured as part of adverse event (AE) reporting
Secondary Outcome Measures:
- Bone pain (all grade) by cycle (2-4) and across cycles [ Time Frame: Will be assessed 30 days after all subjects complete chemotherapy ] [ Designated as safety issue: No ]Bone pain (all grade) by cycle (2-4) and across cycles (up to and including 4 cycles)
- Severe (grade 3/4) bone pain by cycle and across cycles [ Time Frame: Will be assessed 30 days after all subjects complete chemotherapy ] [ Designated as safety issue: No ]Severe (grade 3/4) bone pain by cycle and across cycles (up to and including 4 cycles)
- Subject reported bone pain [ Time Frame: Will be assessed 30 days after all subjects complete chemotherapy ] [ Designated as safety issue: No ]Subject-reported bone pain by cycle and across cycles (up to and including 4 cycles)
- Maximum Subject Reported bone pain [ Time Frame: Will be assessed 30 days after all subjects complete chemotherapy ] [ Designated as safety issue: No ]Maximum subject-reported bone pain by cycle and across cycles (up to and including 4 cycles)
- Area under the Curve for subject-reported bone pain [ Time Frame: Will be assessed 30 days after all subjects complete chemotherapy ] [ Designated as safety issue: No ]AUC for subject-reported bone pain during by cycle and across all cycles (up to and including 4)
- Adverse Event and Serious Adverse Events [ Time Frame: Will be assessed 30 days after all subjects complete chemotherapy ] [ Designated as safety issue: Yes ]AEs and Serious Adverse Events (SAEs) related to pegfilgrastim, naproxen, or loratadine
- Severity of Adverse Events [ Time Frame: Will be assessed 30 days after all subjects complete chemotherapy ] [ Designated as safety issue: Yes ]Severity of AEs related to pegfilgrastim, naproxen, or loratadine
| Estimated Enrollment: | 600 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Prophylactic naproxen |
Drug: Naproxen
Subjects will receive prophylactic naproxen 500 mg twice a day (BID) taken orally beginning the day of pegfilgrastim administration, and continuing for 5 days in total
|
| Experimental: Prophylactic loratadine |
Drug: Loratadine
Subject will receive prophylactic loratadine 10 mg once a day (QD) taken orally beginning the day of pegfilgrastim administration, and continuing for 5 days in total
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Age 18 years or older
- ECOG performance status 0-2
- Female with newly diagnosed, chemo-naive stage I-III breast cancer
- Medically eligible to safely receive adjuvant or neoadjuvant chemotherapy, pegfilgrastim, naproxen and loratadine as determined by investigator
- Creatinine ≤ 1.5 X upper limit of normal
- Planning to receive at least 4 cycles of adjuvant or neoadjuvant chemotherapy
- Planning to receive prophylaxis with pegfilgrastim starting in the first cycle and continuing throughout each chemotherapy cycle of the treatment period
- Other criteria may apply
Key Exclusion Criteria:
- History of other malignancy within past 5 years
- History of clinically significant bleeding disorders, thromboembolism within 6 months
- Currently enrolled in another investigational device or drug study
- Planning to receive weekly chemotherapy
- Ongoing chronic pain, or other painful conditions requiring treatment
- Chronic steroid use
- Chronic use of (NSAIDs) or anti-histamines outside of those dictated by randomization groups
- Prior use of granulocyte-colony stimulating factor (G-CSF)
- History of clinically significant gastrointestinal (GI) bleeding, history of GI ulcers or active GI bleeding within 6 months prior to randomization
- Other criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712009
Show 42 Study Locations
Contacts
| Contact: Amgen Call Center | 866-572-6436 |
Show 42 Study LocationsSponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01712009 History of Changes |
| Other Study ID Numbers: | 20110147 |
| Study First Received: | October 19, 2012 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Amgen:
|
Breast cancer Chemotherapy Neulasta Pegfilgrastim Naproxen |
Loratadine Non-steroidal antiinflammatory drug (NSAID) Anti-histamine Bone Pain |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Naproxen Anti-Inflammatory Agents, Non-Steroidal Loratadine Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents |
Therapeutic Uses Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Antipruritics Dermatologic Agents Anti-Allergic Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 16, 2013