A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00796107
• Collaborator: (none)
• Enrollment: 6
• Locations: 6
• Arm: 1
• Actual Duration (Months): 13.1
• Patient Per Site: 1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study aim was to determine the safety and efficacy of R1507 in combination with letrozole in patients with advanced breast cancer. In the first part of the study a cohort of patients with advanced breast cancer received letrozole 2.5mg po daily in combination with R1507 16mg/kg every 3 weeks.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: RG1507; Drug: Letrozole	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label Study to Evaluate the Safety, Tolerability and Effect on Tumor Response of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer.
• Actual Study Start Date: Jan 28, 2009
• Actual Primary Completion Date: Mar 3, 2010
• Actual Study Completion Date: Mar 3, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: R1507 in Combination With Letrozole Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.	Drug: RG1507; R1507 was administered at a dose 16 mg/kg every 3 weeks.; Drug: Letrozole; Letrozole was administered orally at a dose 2.5 mg daily.

Outcome Measures

Primary Outcome Measures

1. Objective Tumor Response (Part 2) [Up to 14 months]

Secondary Outcome Measures

1. Pharmacokinetics (PK) Profile (Part 2) [Up to 14 months]

2. Progression-free Survival (Part 2) [Up to 14 months]

3. Number of Participants With Adverse Events (Part 2) [Up to 14 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• postmenopausal female patients;

• stage IV or locally advanced breast cancer;

• measurable disease;

• letrozole failure (Part 2);

• Eastern Cooperative Oncology Group (ECOG) performance status <=2.

Exclusion Criteria:

• previous chemotherapy for metastatic breast cancer;

• concurrent antibody or immunotherapy for advanced disease, within 4 weeks prior to receipt of study drug;

• history of primary malignancy in 5 years prior to study, excluding adequately treated basal or squamous cell cancer of skin, or cancer in situ of cervix;

• concurrent radiotherapy, or radiotherapy within 28 days prior to receipt of study drug.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States	35294-3300
2		Washington	District of Columbia	United States	20007
3		Miami	Florida	United States	33136
4		Atlanta	Georgia	United States	30322
5		Saint Louis	Missouri	United States	63110
6		Houston	Texas	United States	77030

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT00796107
• Other Study ID Numbers: NO21161
• First Posted: Nov 24, 2008
• Last Update Posted: Nov 13, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Breast Neoplasms; Letrozole

Study Results

Participant Flow

Arm/Group Title	R1507 in Combination With Letrozole
Arm/Group Description	Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
Period Title: Overall Study
STARTED	6
COMPLETED	0
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	R1507 in Combination With Letrozole
Arm/Group Description	Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
Overall Participants	6
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 16.7%
>=65 years	5 83.3%
Sex: Female, Male (Count of Participants)
Female	6 100%
Male	0 0%
Race/Ethnicity, Customized (Number) [Number]
White	6 100%

Outcome Measures

1. Primary Outcome

Title	Objective Tumor Response (Part 2)
Time Frame	Up to 14 months

Outcome Measure Data

Analysis Population Description

Phase 2 of this study was not conducted.

Arm/Group Title	R1507 in Combination With Letrozole
Arm/Group Description	Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
Measure Participants	0

2. Secondary Outcome

Title	Pharmacokinetics (PK) Profile (Part 2)
Time Frame	Up to 14 months

Outcome Measure Data

Analysis Population Description

Phase 2 of this study was not conducted.

Arm/Group Title	R1507 in Combination With Letrozole
Arm/Group Description	Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
Measure Participants	0

3. Secondary Outcome

Title	Progression-free Survival (Part 2)
Time Frame	Up to 14 months

Outcome Measure Data

Analysis Population Description

Phase 2 of this study was not conducted.

Arm/Group Title	R1507 in Combination With Letrozole
Arm/Group Description	Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
Measure Participants	0

4. Secondary Outcome

Title	Number of Participants With Adverse Events (Part 2)
Time Frame	Up to 14 months

Outcome Measure Data

Analysis Population Description

Since Phase 2 of this study was not conducted, this outcome measure was not collected.

Arm/Group Title	R1507 in Combination With Letrozole
Arm/Group Description	Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
Measure Participants	0

Adverse Events

Time Frame	Baseline up to 13 months
Arm/Group Title	R1507 in Combination With Letrozole
Arm/Group Description	Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
All Cause Mortality
	R1507 in Combination With Letrozole
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Serious Adverse Events
	R1507 in Combination With Letrozole
	Affected / at Risk (%)	# Events
Total	1/6 (16.7%)
Gastrointestinal disorders
Diarrhoea	1/6 (16.7%)	1
Other (Not Including Serious) Adverse Events
	R1507 in Combination With Letrozole
	Affected / at Risk (%)	# Events
Total	6/6 (100%)
Blood and lymphatic system disorders
Lymphopenia	1/6 (16.7%)	1
Thrombocytopenia	1/6 (16.7%)	1
Cardiac disorders
Diastolic Dysfunction	1/6 (16.7%)	1
Ear and labyrinth disorders
Vertigo	1/6 (16.7%)	1
Gastrointestinal disorders
Vomiting	1/6 (16.7%)	1
Diarrhoea	3/6 (50%)	4
Rectal Haemorrhage	1/6 (16.7%)	1
Constipation	1/6 (16.7%)	1
Stomatitis	1/6 (16.7%)	1
General disorders
Chills	2/6 (33.3%)	2
Fatigue	4/6 (66.7%)	5
Irritability	1/6 (16.7%)	1
Infections and infestations
Oral Candidiasis	1/6 (16.7%)	1
Pneumonia	1/6 (16.7%)	1
Injury, poisoning and procedural complications
Animal Bite	1/6 (16.7%)	1
Investigations
Blood creatinine increased	1/6 (16.7%)	1
Metabolism and nutrition disorders
Hypokalaemia	1/6 (16.7%)	1
Decreased Apetite	1/6 (16.7%)	2
Hyperglycaemia	1/6 (16.7%)	2
Musculoskeletal and connective tissue disorders
Arthralgia	1/6 (16.7%)	1
Bone Pain	4/6 (66.7%)	5
Muscle Spasms	3/6 (50%)	3
Nervous system disorders
Headache	1/6 (16.7%)	1
Dizziness	1/6 (16.7%)	1
Dysgeusia	1/6 (16.7%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/6 (16.7%)	1
Sinus Congestion	1/6 (16.7%)	1
Skin and subcutaneous tissue disorders
Hyperhidrosis	1/6 (16.7%)	1
Vascular disorders
Deep Vein Thrombosis	1/6 (16.7%)	1

Limitations/Caveats

Phase 2 of this study was not conducted.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.