A Study to Evaluate the Safety and Pharmacology of DNIB0600A in Participants With Platinum-Sensitive Ovarian Cancer or Non-Squamous Non-small Cell Lung Cancer

Study summary

This open-label, multicenter, phase 1b study will evaluate the safety and pharmacokinetics of DNIB0600A in participants with platinum-sensitive ovarian cancer (PSOC) or Non-Squamous Non-small Cell Lung Cancer (NSCLC). The maximum tolerated dose of intravenously infused DNIB0600A in combination with carboplatin will be determined in escalating dose cohorts. The combination of DNIB0600A and carboplatin will then be evaluated with and without bevacizumab \[Avastin\] in three dose expansion cohorts.

Ask AI to explain this study

Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBevacizumab and Carboplatin

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 4, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?Genentech, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Genentech, Inc.
Interventions being studied: Drug: Bevacizumab; Drug: Carboplatin; Drug: DNIB0600A

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
Histologically documented epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that is platinum sensitive.
PSOC (i.e., epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer) with documented radiographic progression or relapse within 6 to 18 months of most recent platinum-based chemotherapy.
Female participants of childbearing potential must use effective contraception as defined by study protocol and cannot be pregnant or breastfeeding. NSCLC-specific Inclusion Criteria:
Histological documentation of incurable, locally advanced, or metastatic non-squamous
NSCLC that has progressed on prior treatment
Not more than 2 prior regimens in the metastatic setting, including one prior cytotoxic regimen and one prior non-cytotoxic regimen (prior treatment with adjuvant therapy within 6 months of recurrence is considered a treatment regimen in the metastatic setting).
For participants with a documented epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) rearrangement, one additional line of non-cytotoxic prior treatment will be permitted provided the therapy is a targeted agent against the EGFR mutation or ALK rearrangement.
For participants with lung cancer, centrally confirmed high expression of a sodium-dependent phosphate transporter (NaPi2b) by immunohistochemistry (IHC) is required (i.e., IHC 2+ or 3+).

Reasons someone may not be able to joinExclusion criteria

Anti-tumor therapy of any kind or major surgery within 4 weeks prior to Day 1.
For ovarian cancer participants only, platinum-based chemotherapy within 6 months prior to Day 1.
For ovarian cancer participants only, platinum treatment with more than two platinum-based chemotherapy regiments or more than four anti-cancer regimens, overall, for the treatment of ovarian cancer.
Palliative radiation within 2 weeks prior to Day 1.
Toxicity (except alopecia and anorexia) from prior therapy or neuropathy of grades \> 1.
Evidence of any significant disease or condition that could affect compliance with the protocol or interpretation of results.
Known active infection (except fungal nail infections).
History of liver disease or human immunodeficiency virus (HIV).
Other malignancy within the last 5 years, except for adequately treated or controlled carcinoma in situ of the cervix or skin cancer or primary endometrial cancer of stage \</= 1B.
Untreated or active central nervous system (CNS) metastases.
Prior treatment with NaPi2b- targeted therapy. Bevacizumab-Specific

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Massachusetts General Hospital.Boston, Massachusetts
Dana Farber Cancer Inst.Boston, Massachusetts
The University of OklahomaOklahoma City, Oklahoma
The Sarah Cannon Research InstNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 4, 2017. Always confirm current availability with the study team.

View original record ↗