Phase 1 N=49 Basic Science

A Study of Olaratumab and Doxorubicin in Participants With Advanced Soft Tissue Sarcoma

Sarcoma, Soft Tissue

Bottom Line

View on ClinicalTrials.gov: NCT02326025 ↗

Enrolled (actual)

Serious AEs

36.7%

Results posted

Nov 2019

Primary outcome: Primary: Pharmacokinetics (PK): Area Under The Concentration Curve Zero to Infinity (AUC[0-∞]) Doxorubicin — 2580; 2570; 2400; 2470 nanogram*hour/milliliter (ng*h/mL)

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Olaratumab (Drug); Doxorubicin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetics (PK): Area Under The Concentration Curve Zero to Infinity (AUC[0-∞]) Doxorubicin	2580; 2570; 2400; 2470	—
PRIMARY PK: Maximum Concentration (Cmax) Doxorubicin	2570; 2330; 2060; 2070	—
SECONDARY PK:Time of Maximum Observed Concentration (Tmax) Doxorubicin	0.30; 0.31; 0.33; 0.33	—
SECONDARY PK: AUC Zero to Time t, Where t is the Last Time Point (0-tLast) Olaratumab	32800; 32000; 53800; 54100	—
SECONDARY PK: Cmax Olaratumab	292; 386; 512; 634	—
SECONDARY PK: Tmax Olaratumab	2.00; 2.79; 1.67; 3.50	—
SECONDARY Percentage of Participants With Olaratumab Antibodies	0; 0	—
SECONDARY Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]	12.0; 25.0	—

Summary

The purpose of this study is to assess how the body handles olaratumab when it is given with another drug called doxorubicin. The safety and tolerability of these drugs will be studied. Each participant will complete two 21-day cycles in a fixed order. Participants who complete Cycle 2 may continue to receive olaratumab + doxorubicin for an additional six 21-day cycles and then may receive olaratumab alone until discontinuation criteria are met. Screening is required within 21 days prior to first dose. Part B was added in October, 2015 to assess how the body handles a higher dose of olaratumab when given with doxorubicin. Participants may only enroll in one part.

Eligibility Criteria

Inclusion Criteria

Have histological or cytological evidence of a diagnosis of soft tissue sarcoma (STS) that is advanced and/or metastatic
Have the presence of measurable and/or nonmeasurable disease
Have given written informed consent prior to any study-specific procedures
Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale
Have discontinued previous treatments for cancer and recovered from the acute effects of therapy
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria

Have received treatment within 28 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device for noncancer indications
Have received prior treatment with doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones
Have active central nervous system (CNS) metastasis. Participants with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids
Have unstable hepatic disease with a grade equal to or greater than Child-Pugh B
Have an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis
Have a history of another primary cancer, with the exception of a) curatively resected nonmelanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor treated with curative intent, no known active disease present, and no treatment administered during the last 3 years prior to study entry
Have a history of chronic heart failure or left ventricular dysfunction
Have a resting heart rate of less than ( )100 bpm
Have a history of radiation therapy involving the mediastinal/pericardial area. Previous radiation therapy is allowed but must not have included whole pelvis radiation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02326025). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.