A Study of the Safety and Pharmacology of GDC-0980 in Combination With Either Paclitaxel and Carboplatin (With or Without Bevacizumab) or Pemetrexed and Cisplatin in Patients With Solid Tumors
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ClinicalTrials.gov Identifier: NCT01301716 |
Recruitment Status :
Completed
First Posted : February 23, 2011
Last Update Posted : November 2, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Cancers | Drug: GDC-0980 Drug: bevacizumab Drug: carboplatin Drug: cisplatin Drug: paclitaxel Drug: pemetrexed | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 75 participants |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0980 in Combination With Either Paclitaxel and Carboplatin (With or Without Bevacizumab) or Pemetrexed and Cisplatin in Patients With Solid Tumors |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | August 2014 |
Actual Study Completion Date : | August 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: A |
Drug: GDC-0980
Oral escalating dose Drug: carboplatin Intravenous repeating dose Drug: paclitaxel Intravenous repeating dose |
Experimental: B |
Drug: GDC-0980
Oral escalating dose Drug: bevacizumab Intravenous repeating dose Drug: carboplatin Intravenous repeating dose Drug: paclitaxel Intravenous repeating dose |
Experimental: C |
Drug: GDC-0980
Oral escalating dose Drug: cisplatin intravenous repeating dose Drug: pemetrexed intravenous repeating dose |
- Incidence of adverse events [ Time Frame: Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first ]
- Incidence of dose limiting toxicities (DLTs) [ Time Frame: Up to 21 days from Last Patient In (LPI) in Stage 1 of study ]
- Nature of adverse events [ Time Frame: Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first ]
- Nature of dose limiting toxicities (DLTs) [ Time Frame: Up to 21 days from Last Patient In (LPI) in Stage 1 of study ]
- Severity of adverse events [ Time Frame: Up to 30 days after last dose of study treatment ]
- Total exposure [ Time Frame: Up to 32 months or early study discontinuation ]
- Maximum plasma concentration [ Time Frame: Up to 32 months or early study discontinuation ]
- Time to maximum observed plasma concentration [ Time Frame: Up to 32 months or early study discontinuation ]
- Plasma half-life [ Time Frame: Up to 32 months or early study discontinuation ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically documented, incurable, locally advanced, or metastatic solid malignancy
- Adequate hematologic and end organ function
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement to use an effective form of contraception and to continue its use for the duration of the study
- Measurable disease per RECIST (Response Evaluable Criteria in Solid Tumors), with the exception of prostate cancer (two rising PSA Levels that meet the criteria of progression per PSA Working Group) and ovarian cancer (two rising CA-125 levels greater than the ULN)
Exclusion Criteria:
- Current dyspnea at rest due to complications of advanced malignancy, or other conditions requiring continuous supplemental oxygen
- Uncontrolled hypomagnesemia or hypokalemia
- History of Grade >= 3 fasting hyperglycemia
- Any condition requiring full-dose anticoagulants
- Known HIV infection
- Known untreated or active central nervous system (CNS) metastases
- Pregnancy, lactation, or breastfeeding
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the first dose of study treatment or anticipation of need for major surgical procedure during the course of the study
- For Arm B: Conditions that preclude the use of bevacizumab
- For Arm C: Conditions that preclude the use of pemetrexed or cisplatin

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301716
United States, California | |
Los Angeles, California, United States, 90025 | |
United States, Florida | |
Tampa, Florida, United States, 33612 | |
United States, Massachusetts | |
Boston, Massachusetts, United States, 02114 | |
Boston, Massachusetts, United States, 02215 | |
Spain | |
Madrid, Spain, 28050 |
Study Director: | Clinical Trials | Genentech, Inc. |
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT01301716 |
Other Study ID Numbers: |
PIM4946g GO01336 ( Other Identifier: Hoffmann-La Roche ) |
First Posted: | February 23, 2011 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | November 2016 |
Paclitaxel Bevacizumab Cisplatin Carboplatin Pemetrexed Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |