A Phase 1b, Open-label, Dose-finding Study of AMG 706 in Combination With Gemcitabine and Erlotinib to Treat Subjects With Solid Tumors

NCT01235416 | Completed Phase 1

• 1 other identifier: 20050107
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is an open-label, dose-finding study to determine the target or maximum-tolerated dose and to characterize the safety and pharmacokinetic profile of AMG 706 administered in combination with erlotinib with or without gemcitabine in subjects with solid tumors.

Conditions

Histologically or Cytologically Documented Solid Tumors

Outcome Measures

Primary Outcomes (1)

• incidence of dose-limiting toxicities

  Subjects will be in this study for up to 54 weeks (ie, 2 weeks screening, 48 weeks treatment and 4 weeks follow-up) or longer if subjects are deemed to have continuous clinical benefit from the combination chemotherapy and AMG 706

Secondary Outcomes (2)

• Incidence of adverse events (including serious and treatment-related) and significant laboratory values other than those defined as dose-limiting toxicities

  Subjects will be in this study for up to 54 weeks (ie, 2 weeks screening, 48 weeks treatment and 4 weeks follow-up) or longer if subjects are deemed to have continuous clinical benefit from the combination chemotherapy and AMG 706

• pharmacokinetic profiles of erlotinib and AMG 706

  Subjects will be in this study for up to 54 weeks (ie, 2 weeks screening, 48 weeks treatment and 4 weeks follow-up) or longer if subjects are deemed to have continuous clinical benefit from the combination chemotherapy and AMG 706

Study Arms (3)

AMG 706 50mg

ACTIVE COMPARATOR

50 mg, once daily. (Cohort 1)

Drug: AMG 706

AMG 706 75mg

ACTIVE COMPARATOR

75 mg, twice daily. (Cohort 2)

Drug: AMG 706

AMG 706 125mg

ACTIVE COMPARATOR

125 mg, once daily. (Cohort 3)

Drug: AMG 706

Interventions

AMG 706 DRUG

In each of these 3 planned treatment cohorts, approximately 6 evaluable subjects will be treated with gemcitabine (1000-mg/m2 intravenously over 30 minutes, once weekly starting on day 1, week 1 of cycle 1) and erlotinib (100 mg orally once daily starting on day 1, week 1 of cycle 1)

AMG 706 125mg; AMG 706 50mg; AMG 706 75mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically or cytologically documented solid tumors
• candidates for gemcitabine and erlotinib treatment (for cohorts with gemcitabine), in the opinion of the investigator
• candidates for erlotinib treatment (for cohorts without gemcitabine), in the opinion of the investigator
• Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2 (see Appendix E)
• systolic blood pressure ≤ 145 mm Hg and diastolic blood pressure ≤ 85 mm Hg (hypertension therapy is allowed)
• at least 18 years of age when written informed consent is obtained
• before any study-specific procedure is performed, the appropriate approved written informed consent must be obtained (Section 12.1).

You may not qualify if:

• nonsmall-cell lung cancer with squamous-cell histology
• large central tumor lesions (ie, ≥ 3 centimeters and located adjacent to or within the hilum or mediastinum)
• direct bowel wall invasion except for primary tumors of the bowel
• evidence of active bleeding or bleeding diathesis
• total gastrectomy
• hematologic malignancies
• untreated or symptomatic brain metastases
• history or evidence of interstitial lung disease
• past or current history of second neoplasm, except for curatively treated non-melanoma skin cancer, carcinoma in situ of the cervix and other primary solid cancer with no known active disease present and no curative treatment administered for the last 3 years
• documented myocardial infarction within 1 year before study day 1
• arterial thrombosis or deep vein thrombosis within 1 year before study day 1
• unstable or uncontrolled disease/condition related to or impacting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association (NYHA) \> class II \[Appendix F\])
• major surgical procedure within 30 days before study day 1
• known positive test for human immunodeficiency virus (HIV)
• absolute neutrophil count (ANC) \< 1.5 x 109 /L

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• Kotasek D, Tebbutt N, Desai J, Welch S, Siu LL, McCoy S, Sun YN, Johnson J, Adewoye AH, Price T. Safety and pharmacokinetics of motesanib in combination with gemcitabine and erlotinib for the treatment of solid tumors: a phase 1b study. BMC Cancer. 2011 Jul 26;11:313. doi: 10.1186/1471-2407-11-313.

  PMID: 21791058 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

motesanib diphosphate

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: November 5, 2010
• Study Start: September 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: February 1, 2010
• Last Updated: January 21, 2011

Record last verified: 2011-01